FDA Adverse Event Injury Summary report: N

WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

MDR report key: 12610751 · Received October 11, 2021

Report

Report Number
2134265-2021-12636
Event Type
Injury
Date Received
October 11, 2021
Date of Event
August 13, 2021
Report Date
October 11, 2021
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
NGV
UDI-DI
08714729860488
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
KY, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT A SYSTEMIC EMBOLISM OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A 20MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM WERE USED. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH PRESCRIPTIONS FOR ASPIRIN AND APIXABAN, AN ANTICOAGULANT. ON (B)(6) 2021, 94 DAYS POST PROCEDURE, THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT WITH CHEST PAIN WHEN COUGHING. THE PATIENT HAD CEASED TAKING APIXABAN AND PRESENTED SWELLING OF THE FEET. THE PATIENT WAS ADMITTED TO ANOTHER MEDICAL FACILITY TO TREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), POSSIBLE VASCULAR INEFFICIENCY IN THE LEFT LOWER EXTREMITY, AND CONCERNS OF DEEP VEIN THROMBOSIS (DVT). A LOWER VENOUS DUPLEX SCAN INDICATED NO EVIDENCE FOR ACUTE, DEEP, OR SUPERFICIAL THROMBOSIS OF THE LOWER EXTREMITIES. LOWER EXTREMITY ARTERIAL DOPPLER REVEALED THE ANKLE BRACHIAL INDEX (ABI) WERE NORMAL AT REST AND THERE WAS NO INDICATION OF DIGITAL ISCHEMIA. THE ARTERIAL SEGMENTAL DOPPLER INDICATED BLUNTED WAVEFORMS IN THE DIGITS OF THE LOWER LEFT EXTREMITY. IT WAS CONCLUDED THAT THE PATIENT POSSIBLY HAD AN EMBOLIZATION DISTALLY RELATED TO ATRIAL FIBRILLATION. THE PATIENT WAS ADMINISTERED INTRAVENOUS HEPARIN, AN ANTICOAGULANT, THEN APIXABAN 5MG TWICE DAILY. ON (B)(6) 2021 THE EVENT WAS DEEMED RESOLVED AND THE PATIENT WAS DISCHARGED. THE PATIENT WILL FOLLOW UP WITH THEIR PRIMARY CARE PHYSICIAN AT A LATER DATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1505690 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0026739617 08714729860488

Patients

Seq Age Sex Outcome Treatment
1 62 YR Other