FDA Adverse Event Injury Summary report: N

WATCHMAN FLX? PRO

MDR report key: 22771441 · Received August 11, 2025

Report

Report Number
2124215-2025-55305
Event Type
Injury
Date Received
August 11, 2025
Date of Event
July 24, 2025
Report Date
April 24, 2026
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
NGV
UDI-DI
00191506004613
PMA / PMN Number
P130013
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED ON A PATIENT WITH A PACEMAKER AND HISTORY OF VON WILLEBRAND DISEASE. A WATCHMAN DOUBLE CURVE ACCESS SYSTEM (WAS) AND A 27MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. THE TRANSEPTAL PUNCTURE (TSP) WAS COMPLETED WITH A VERSACROSS CONNECT IN AN INFERIOR/MID LOCATION ON THE FOSSA USING INTRACARDIAC ECHO (ICE) GUIDANCE. THE PHYSICIAN HAD CHALLENGES GETTING THE VERSACROSS WIRE PAST THE PACER LEADS AND HAD TO REDIRECT SEVERAL TIMES. AFTER GETTING ACROSS TO LEFT SIDE, THE 27MM WDS WAS ADVANCED AND DEPLOYED. IT WAS NOTED THAT THE 27MM WDS WAS TOO SMALL AND HAD LOW COMPRESSION. THE 27MM WDS WAS REMOVED AND REPLACED WITH A LARGER 31MM WATCHMAN FLX PRO DEVICE. THE 31MM WDS MET POSITION, ANCHOR, SIZE AND SEAL (PASS) CRITERIA AND THE 31MM CLOSURE DEVICE RELEASED. A PERICARDIAL EFFUSION SWEEP WAS PERFORMED BEFORE THE PROCEDURE, SEVERAL TIMES DURING AND AFTER IMPLANT PROCEDURE WITH NO FINDINGS. IT WAS REPORTED THAT AFTER THE PATIENT WAS RETURNED TO POST-OP CARE AREA, THE PATIENT BLOOD PRESSURE WAS OBSERVED TO BE NOTABLY LOWER. THE ANESTHESIOLOGIST PERFORMED A LIMITED ECHO AND NO PERICARDIAL EFFUSION WAS SEEN. PER THE ANESTHESIOLOGIST, ALBUMIN AND FLUIDS WERE ADMINISTERED AND THE PATIENT VITALS TEMPORARILY RETURNED TO NORMAL. ABOUT 15-20 MINUTES LATER THE PATIENT BLOOD PRESSURE SOFTENED AND ANOTHER ECHO WAS PERFORMED. AT THIS TIME A MODERATE EFFUSION WAS SEEN ON IMAGING. THE PATIENT WAS TAKEN TO THE CATH LAB WHERE ABOUT 400ML OF BLOOD WAS REMOVED TO TREAT THE EFFUSION. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) ONCE STABILIZED AND MONITORED OVERNIGHT. THE FOLLOWING MORNING, THE DRAIN WAS REMOVED FROM PATIENT'S CHEST. PER IMPLANTER, THE PATIENT WAS DOING WELL AND WAS PLANNED TO BE DISCHARGED THE NEXT DAY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
230243 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60310 0036392092 00191506004613

Patients

Seq Age Sex Outcome Treatment
1 79 YR Female Required Intervention| H