ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION

MDR report key: 2800408 · Received October 16, 2012

Report

Report Number: 1820334-2012-00480
Event Type: Injury
Date Received: October 16, 2012
Date of Event: September 28, 2012
Report Date: September 28, 2012
Manufacturer: COOK, INC.
Product Code: MIH
PMA / PMN Number: P020018
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVENT EVAL: STILL UNDER INVESTIGATION.

Description of Event or Problem · 1

A (B)(6) MALE PT UNDERWENT AAA REPAIR WITH RIGHT APPROACH. THE PT WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WAS CONDUCTED AS LABELED; PROXIMAL NECK DIAMETER: 30MM, ACCESS ROUTE (RIGHT AND LEFT): 8-9MM, DIAMETER OF ANEURYSM: 50MM, NO CALCIFICATION OR BLOOD CLOTS OBSERVED. CONTRALATERAL (LEFT) ILIAC LEG GRAFT WAS EVENTUALLY PLACED OVERLAPPING 2 STENTS OF THE MAIN BODY THOUGH IT WAS SUPPOSED TO OVERLAP ONLY 1.5 STENT. FINAL CONFIRMATORY ANGIOGRAPHY TAKEN IN THE GRAFT CONFIRMED TYPE IV ENDOLEAK FROM THE MAIN BODY. THEN, BODY EXTENSION WAS ADDITIONALLY PLACED IN THE POSITION OF THE SECOND AND THIRD STENTS OF THE MAIN BODY. HOWEVER, ENDOLEAK WAS NOT RESOLVED. (1820334-2012-00479). DUE TO THE PLACING POSITIONS OF THE EXTENSION AND THE LEFT ILIAC LEG, THE BODY EXTENSION OCCLUDED PROXIMAL SITE OF THE CONTRALATERAL (LEFT) ILIAC LEG GRAFT, WHICH RESULTED IN ABSENT PULSE IN THE LEFT EXTREMITY. THEN, FEM-FEM BYPASS WAS PERFORMED, AND BLOOD FLOW RETURNED. (1820334-2012-00480). THERE HAS BEEN NO ADVERSE EFFECTS TO THE PT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION	MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	COOK, INC.	NA	3156617

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Required Intervention