ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

MDR report key: 1922919 · Received October 19, 2010

Report

Report Number: 3002808486-2010-00013
Event Type: Injury
Date Received: October 19, 2010
Date of Event: September 21, 2010
Report Date: September 21, 2010
Manufacturer: WILLIAM COOK EUROPE
Product Code: MIH
PMA / PMN Number: P070016
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT IS STILL UNDER INVESTIGATION.

Description of Event or Problem · 1

A (B)(6) FEMALE PT UNDERWENT THORACIC ANEURYSM REPAIR ON (B)(6) 2010. THE PHYSICIAN WAS TREATING A PENETRATING ULCER WITH SACCULAR ANEURYSM OF DISTAL ARCH. SUBCLAVIAN BYPASS WAS COMPLETED AND A 16 AMPLATZER WAS PLACED, DISTAL TO THE LEFT CAROTID ARTERY. DURING THE PROCEDURE, COOK ENGINEERS WERE CALLED BECAUSE THE TX2 DEVICE WAS FULLY DEPLOYED AND ALL TRIGGER WIRES WERE OUT OF THE PT AND ACCOUNTED FOR. DEVICE APPEARED TO NOT BE FULLY OPENED. PLACEMENT WAS EXACT, MINIMAL MOVEMENT, PT'S BLOOD PRESSURE WAS STABLE AND BREATH WAS HELD DURING DEPLOYMENT. FEMORAL ARTERIES WERE VERY SMALL AND DISEASED AND RUPTURED WHEN DEVICE WAS REMOVED, A CONDUIT WAS SUGGESTED. THE PHYSICIANS WERE VERY AWARE RUPTURE WAS POSSIBLE AND HAD VIABONDS ON HAND AND BALLOON IN THE EVENT IT OCCURRED. PT ALSO HAD A HISTORY PREVIOUS OPEN AAA REPAIR W/AORTO BI ILIAC BYPASS GRAFT. FROM THE INFO PROVIDED BY THE REPORTER, A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT	MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	WILLIAM COOK EUROPE	NA	E2615385

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention