ENDURANT II

MDR report key: 4003154 · Received August 12, 2014

Report

Report Number: 2953200-2014-01576
Event Type: Injury
Date Received: August 12, 2014
Date of Event: July 18, 2014
Report Date: July 18, 2014
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

A ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 6 CM ABDOMINAL AORTIC ANEURYSM. THE DIAMETER OF THE NECK WAS 23 MM, WITH A LENGTH OF 17 MM AND AN ANGULATION OF 45 DEGREES. ACCESS VESSEL TORTUOSITY AND CALCIFICATION WERE REPORTED TO BE MILD. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO IMPLANT THE STENT GRAFT. THE GRAFT WAS INTENTIONALLY LANDED APPROXIMATELY 5 MM BELOW THE ORIGINALLY INTENDED POSITION, AS THE PHYSICIAN FELT THE NECK WAS LONG ENOUGH TO DO SO. THIS RESULTED IN A TYPE I ENDOLEAK. THE PHYSICIAN IMPLANTED A CUFF AT THE LEVEL OF THE LOWEST RENAL ARTERY. AFTER BALLOONING, A FINAL ANGIOGRAM WAS PERFORMED, AND THE LEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
478778	ENDURANT II	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V04252948

Patients

Seq	Age	Sex	Outcome	Treatment
1	00073 YR		Required Intervention