FDA Adverse Event Injury Summary report: N

WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

MDR report key: 6125707 · Received November 23, 2016

Report

Report Number: 2134265-2016-10861
Event Type: Injury
Date Received: November 23, 2016
Date of Event: November 1, 2016
Report Date: November 1, 2016
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NGV
PMA / PMN Number: P130013
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MDR ID: 2134265-2016-10860. IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM WAS ADVANCED THROUGH A WATCHMAN ACCESS SYSTEM. THE CLOSURE DEVICE WAS DEPLOYED AND RELEASED SUCCESSFULLY. AN ECHOCARDIOGRAM AND ANGIOGRAM WERE PERFORMED WHICH CONFIRMED THERE WAS NO PERICARDIAL EFFUSION. ABOUT 30-50 MINUTES AFTER THE DEVICE WAS IMPLANTED, THE PATIENT'S BLOOD PRESSURE DROPPED. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND SHOWED A PERICARDIAL EFFUSION. THEY DRAINED ABOUT 300ML OF BLOOD FROM THE PATIENT. PROTAMINE WAS GIVEN TO THE PATIENT AND THE BLEEDING STOPPED. THE PATIENT STAYED OVERNIGHT IN THE INTENSIVE CARE UNIT AT THE HOSPITAL AND IS REPORTED TO BE IN STABLE CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
776480	WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM	SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL	NGV	BOSTON SCIENTIFIC - MAPLE GROVE	M635WS21060	0019495859

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Hospitalization\| R