ZENITH RENU AAA, ANCILLARY GRAFT MAIN BODY EXTENSION

MDR report key: 1951889 · Received December 2, 2010

Report

Report Number: 1820334-2010-00680
Event Type: Injury
Date Received: December 2, 2010
Date of Event: December 2, 2010
Report Date: December 2, 2010
Manufacturer: COOK, INC.
Product Code: MIH
PMA / PMN Number: P020018
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVENT EVAL: STILL UNDER INVESTIGATION AT THIS TIME.

Description of Event or Problem · 1

AS REPORTED TO COOK: A MALE PT UNDERWENT AN AAA, ABDOMINAL AORTIC ANEURYSM, REPAIR FOR A TYPE I ENDOLEAK. DURING THE DEPLOYMENT OF THE MAIN BODY EXTENSION, THE DEVICE WOULD NOT DEPLOY IN A PERPENDICULAR FASHION WHILE UNSHEATHING. IT WOULD DEPLOY "LOPSIDED." THE PHYSICIAN THEN DEPLOYED ANOTHER MFR'S STENT (1820334-2010-00679). A RENU EXTENSION WAS THEN DEPLOYED SUCCESSFULLY BUT DID NOT RESOLVE THE ENDOLEAK. THE HEMOSTATIC VALVE LEAKED ON THE RENU DEVICE DURING PLACEMENT. THE PHYSICIAN THEN LEFT THE PROCEDURE DUE TO NOT CONVERTING TO AN OPEN SURGICAL PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZENITH RENU AAA, ANCILLARY GRAFT MAIN BODY EXTENSION	MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	COOK, INC.	NA	2533093

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention