ENDURANT ABDOMINAL STENT GRAFT SYSTEM

MDR report key: 2230691 · Received August 17, 2011

Report

Report Number: 2953200-2011-01451
Event Type: Injury
Date Received: August 17, 2011
Date of Event: May 24, 2011
Report Date: July 19, 2011
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: MIH
PMA / PMN Number: P100021
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: (GRAFT OCCLUSION).

Description of Event or Problem · 1

AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.8 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 3 MONTHS AGO. THE AORTIC NECK WAS 26 MM LONG AND 24 MM IN DIAMETER. THE COMMON ILIAC ARTERIES WERE 11 MM IN DIAMETER, MILDLY TORTUOUS, AND MILDLY CALCIFIED. IT WAS REPORTED THAT THE ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED WITHOUT ISSUES; HOWEVER, APPROXIMATELY 2 MONTHS POST-IMPLANTATION, THE PATIENT PRESENTED WITH MILD CLAUDICATION. A CT DEMONSTRATED A COMPLETE OCCLUSION OF THE IPSILATERAL LIMB. AS THE CLAUDICATION IS MILD AND MANAGEABLE, THE PHYSICIAN HAS ELECTED TO NOT PERFORM ANY INTERVENTION, BUT TO MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDURANT ABDOMINAL STENT GRAFT SYSTEM		MIH	MEDTRONIC CARDIOVASCULAR GALWAY	NA	V00868600

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR