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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
Model Number 10371
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Thrombosis/Thrombus (4440)
Date of Event 10/04/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed and a 33mm watchman flx laa closure device was implanted.At the five-year follow up, a large thrombus measuring 66 x 37 x 31 mm in size was noted to be attached to the posterior and superior aspect of the laa wall and bridged to the watchman device.The device-related thrombus was noted via transthoracic echocardiogram (tte) and confirmed with magnetic resonance imaging (mri).The watchman device continued to occlude the laa.There was no thrombus noted within the laa.It is reported that the patient followed their post-implant drug regiment.The patient was placed on warfarin and expected to follow up to reassess the thrombus in three months.
 
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Brand Name
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
Common Device Name
SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
MDR Report Key12751043
Report Number2134265-2021-13803
Device Sequence Number1453927
Product Code NGV
UDI-Device Identifier08714729838265
UDI-Public08714729838265
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P130013
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date11/18/2016
Device Model Number10371
Device Catalogue Number10371
Device Lot Number0016547563
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/13/2021
Initial Report FDA Received Date11/04/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured12/05/2013
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age75 YR
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