FDA Adverse Event Death Summary report: N

WATCHMAN® ACCESS SYSTEM

MDR report key: 6139393 · Received December 1, 2016

Report

Report Number: 2134265-2016-11066
Event Type: Death
Date Received: December 1, 2016
Date of Event: October 11, 2016
Report Date: November 9, 2016
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NGV
PMA / PMN Number: M110009
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MDR ID: 2134265-2016-11062. IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED AND SUBSEQUENTLY THE PATIENT EXPIRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. THE WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED IN THE LAA AND A 24MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS ADVANCED. THE WATCHMAN LAA CLOSURE DEVICE WAS DEPLOYED IN THE LAA SUCCESSFULLY. SHORTLY AFTER THE PROCEDURE, A PERICARDIAL EFFUSION APPEARED. PERICARDIOCENTESIS WAS PERFORMED AND 400 ML OF FLUID WAS WITHDRAWN. THE PERICARDIAL EFFUSION REAPPEARED AND ANOTHER 400 ML OF FLUID WITHDRAWN. A THORACOTOMY WAS PERFORMED; HOWEVER, THE PATIENT EXPIRED "SOME" HOURS LATER IN THE INTENSIVE CARE UNIT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
789316	WATCHMAN® ACCESS SYSTEM	SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL	NGV	BOSTON SCIENTIFIC - MAPLE GROVE	UNK728

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death\| R