WATCHMAN FLEX LAA Closure Device

I was just reviewing information I received after my WATCHMAN implant. One was the card I should carry in my wallet and the other was information from Boston Scientific regarding the website that was for the “Directions For Use” DFU for this product. I printed the 8 page PDF and was not very happy when I found on page 5 “potential harmful events which may be associated with the use of the Watchman FLX Implant or or implantation procedure included but not limited to………”. The list is very extensive. No one discussed this with me prior to my implant. Perhaps these were listed on the forms that I had to initial or sign, but I think I would have questioned it.

I am wondering if anyone in the “Watchman Club” is aware of this information or if a half page of issues were discussed with you prior to the implant. (Web site is www.Boston scientific-elabeling.com.

I look forward to any responses to this little surprise.

I didn't see that particular document but I was made aware of all the horrible things that can happen when anyone sticks a catheter into your heart for any reason, which is mostly what that list is.

The problem is, you show that list to anyone and they'll be an instant "NO!" even if the procedure is necessary to save their life. The list doesn't include the odds of each thing happening, which is near zero for almost all of them. We're talking about the odds of being struck by lightning in the Arctic. But the list does include all the possible things a completely incompetent operator might do. In fact, that's what most of that list is.

So don't choose an incompetent operator and you can erase almost everything on that list.

You need someone really good.

During one hospitalization, I was assigned an ep because Natale was out of state and his np was on maternity leave. I asked this ep out of curiosity and boredom if he implants the watchman. He was honest and said not anymore because he was tearing hearts. It didn’t matter because I wanted dr Natale to implant it but it made me grateful that dr Natale exists and could implant it, which he did this February. I had no problems and my watchman was successful sealed via 3 TEE confirmations.

Thank you for the responses. Reading the adverse effects of the Watchman are daunting. This further proves to me that choosing a top EP to do my ablation and watchman implant was the right decision. I usually do my research and can’t believe I did not know some of these outcomes before the procedure. BUT, decision was made, the EP is a “top tier” and today I wam doing well.

Just another thought because my anxiety has just increased about a decision I made and was comfortable with until now………I know it is best to have the first and second TEE done in Austin. There was a great response to that post previously. Dr. Natale did refer me to someone in the Midwest for my second and last TEE per my request. Carey, you responded that you would feel confident doing that because of the recommendation from Dr. N. Now having read the adverse effects, I am wondering if having the second done closer to home is a mistake. You gave me the response I wanted in the former post…..I am just “up in the air” once again about this.

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Carey
We're talking about the odds of being struck by lightning in the Arctic.

I was a little freaked out the first time I encountered thunder snow. Lightning, thunder and snow all at the same time. Was expecting blood and locusts but went back inside and fell asleep.

Those caveats are published at the insistence of the underwriters. Offering something to the public that can make you money comes with liability risks that must be mitigated, and that is through premiums and risk-assessment. The insurers of the companies and administering physicians state that patients must be cautioned, and one way to do that is to provide the caveats boldly in the monographs.

Think of the risks associated with apixaban. Would you decline to take it....today...and for the same reasoning?

Or aspirin, Aleve (naproxen), any antibiotic, statins, SSRIs, and so on. They all carry risks. One should ask oneself, "What is the alternative?"

Ill chime in as i too am in the Dr Natale Watchman Club as my journey was a bit different: LAA isolated 8-6-21 (atypical flutter ablation)
2-16-22 return to Austin for my Watchman with Dr Natale. He rather reluctantly approved my request to have the first TEE back in Charlotte: Dr Holshouser EP
3-31-22 TEE - Holshouser called me the day after saying its perfect that it and I could not look better. All results were transmitted back to Austin. In the few weeks after the TEE i had a few tachy runs. I blame the TEE but no proof. Dr Holshouser said based on what he saw there was absolutely no need for another TEE that i was endothelialized. So I decided for me to ride with it. Ive talked back to Austin to advise them. Its been 10 months now. Flutter episodes zero. RHR 58-62. BP 132/78 on avg. at 69 back lifting weights walking & yard work . Fortunately Carey a voice of reason. There a risk to everything and I firmly believe that the past 2-3 yrs of covid etc has elevated FEAR to a new level. Me included. Hell i had covid one yr ago. I was willing to trust my Watchman was sealed & secure. Im on no meds either other than crumbs of propananol. I do take natto garlic olive oil udos oil and other supplements, i walk an hour a day too

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gloaming
One should ask oneself, "What is the alternative?"

Realizing at a younger age that “If I had known I was going to live so long, I’d have taken better care of myself.” isn't just an amusing saying.

Or, as me dear ol' dad told me, "Sin in haste, repent at leisure."

Pixie you will be ok if you get someone experienced. Mine and everyone who belongs to the watchman club were probably nervous but more likely less so if they got a top tier EP. I didn’t give it a thought about iatrogenic problems and picked Natale.

If you decide to pick an Ep solely with a pulse who lives conveniently near you, even then ask questions including if they had complications in their experience of implantations.
[advances.massgeneral.org]



Edited 1 time(s). Last edit at 12/18/2022 11:39PM by susan.d.

Good to hear your take on this, Susan.

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PavanPharter
I was a little freaked out the first time I encountered thunder snow. Lightning, thunder and snow all at the same time. Was expecting blood and locusts but went back inside and fell asleep.

Speaking of thunder snow, this is a true story....

One day a few years ago it was a cold, windy day in February with a mix of sleet and snow. I was shocked to suddenly hear a loud clap of thunder. That was only the second time I'd ever heard thunder snow and I've lived in snow country for over 40 years. Because I was an EMT at the time, pretty soon I heard through the EMS grapevine what that loud clap of thunder actually did.

It seems that a woman was away at church with her children, but her husband had stayed home because he wanted to work in his basement workshop. This apparently displeased God very much, because that clap of thunder was the man getting both of his heels blown off by lightning. Yes, really. In a basement.. underground... in Connecticut... in February.

Apparently, the lightning struck the ground very near his house and the electrical surge fed into his home wiring. He happened to be holding a power tool at the time, which the surge blew up, burning his hand. It then exited through his heels standing on the bare concrete floor. His heels were so badly burned that they were nearly destroyed.

That was the only thunder I heard that day. I bet he hasn't missed a day of church since.

Lol...Carey.

I am an agnostic but am loath to say it out loud, just in case, and here I am writing it for thousands to see ( and maybe the one who sees all just spotted it...oh dear) ><

And I bet he doesn’t go barefoot and he wears rubber shoes to ground himself. Great story! Wouldn’t a surge protected GFCI outlet prevent this?

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susan.d
Wouldn’t a surge protected GFCI outlet prevent this?

Nope. There are no consumer-grade devices that can stop the electrical surge from a direct or very near lightning strike.