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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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BOSTON SCIENTIFIC CORPORATION 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 Stroke/CVA (1770)
Date of Event 05/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event: estimated as it was reported that the event occurred around (b)(6) 2020.
 
Event or Problem Description
It was reported that a cerebral vascular accident occurred.A left atrial appendage (laa) closure procedure was performed and a watchman laa closure device was implanted.In (b)(6) 2020, the patient had a stroke and was prescribed warfarin.The patient was in the process of setting up another magnetic resonance imaging (mri) appointment.
 
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Brand Name
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
Common Device Name
SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11991325
Report Number2134265-2021-07339
Device Sequence Number923990
Product Code NGV
UDI-Device Identifier08714729838234
UDI-Public08714729838234
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P130013
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/14/2021
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 Date12/31/2019
Device Model Number10371
Device Catalogue Number10371
Device Lot Number0020037951
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/25/2021
Initial Report FDA Received Date06/14/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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