ENDURANT ABDOMINAL STENT GRAFT

MDR report key: 2261510 · Received September 21, 2011

Report

Report Number: 2953200-2011-01624
Event Type: Death
Date Received: September 21, 2011
Date of Event: August 1, 2011
Report Date: August 25, 2011
Manufacturer: MEDTRONIC CARDIOVASCULAR IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): RESULTS: DEATH, OCCLUSION, BLEEDING. CAUSE OF EVENTS ARE UNK. CONCLUSIONS: CAUSE OF EVENTS ARE UNK.

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS A STRAIGHT ILIAC ARTERY. ONE BIFURCATED STENT GRAFT, THE ANEURX WAS ON THE RIGHT (MFR REPORT# 2953200-2011-01627) AND TWO ENDURANT LIMBS WERE PLACED ON THE LEFT. IVUS CONFIRMED THEY WERE GOOD. IT WAS REPORTED THAT THE PT PRESENTED WITH A COLD LEFT LEG. THE CT DEMONSTRATED THAT THE LEFT ILIAC LIMB WAS OCCLUDED. (MFR REPORT# 2953200-2011-01624, MFR REPORT# 2953200-2011-01625, AND MFR REPORT# 2953200-2011-01626). THE PHYSICIAN BEGAN THROMBOLYSIS THERAPY WHICH RESOLVED THE OCCLUSION OF THE STENT GRAFT BY THE NEXT MORNING. AFTER THE THROMBOLYSIS THERE WAS NO EVIDENCE OF THE STENT STENOSIS IN EITHER LIMB. THERE WERE NO KINKS, FOLDING, OR ANY DEFECT NOTED IN THE ILIAC STENT GRAFT. LATER THAT SAME DAY, THE PT SUFFERED AN INTRACRANIAL BLEED AND EXPIRED. THE PT HAD ARTERIAL FIBRILLATION AND WAS NOT ON ANTICOAGULATION, SO THE PT MAY HAVE HAD AN EMBOLISM RESULTING IN THE OCCLUSION IN THE ILIAC LIMB.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDURANT ABDOMINAL STENT GRAFT		MIH	MEDTRONIC CARDIOVASCULAR IRELAND	NA	V00846188

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Death