ENDURANT STENT GRAFT SYSTEM

Report

Report Number: 2953200-2011-01261
Event Type: Injury
Date Received: July 8, 2011
Date of Event: June 9, 2011
Report Date: June 9, 2011
Manufacturer: MEDTRONIC CARDIOVASCULAR IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION, RESULTS: (ARTERIAL VESSEL OCCLUSION); (UNKNOWN CAUSE OF EVENT). CONCLUSIONS: (UNKNOWN CAUSE OF EVENT).

Description of Event or Problem · 1

AN ANEURX STENT GRAFT SYSTEM (REF MFR 2953200-2011-01029) WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX SIX YEARS AGO. THE ANEURYSM DIAMETER AT THE TIME OF IMPLANT WAS NOT REPORTED. THE VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 2.5 CM TO 3 CM IN LENGTH AND THE ILIAC LIMBS WERE NARROW IN DIAMETER. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED IN THE PT. A CT SCAN 10 WEEKS AGO DEMONSTRATED THAT THE ANEURYSM MEASURED 5.6 CM ANTERIOR TO POSTERIOR X 5.8 CM TRANSVERSELY. THERE WAS CONTRAST ALONG THE UPPER MARGIN OF THE STENT GRAFT, CONSISTENT WITH A PROXIMAL TYPE I ENDOLEAK. THE PT WAS SUCCESSFULLY TREATED WITH A 28 MM ANEURX CUFF AND A 36 MM ENDURANT CUFF AND THIS RESOLVED THE ENDOLEAK. ON A CT SCAN TAKEN ONE MONTH AGO, THE ENDURANT CUFF (REF MFR 2953200-2011-01261), WHICH WAS PLACED AS THE MOST PROXIMAL GRAFT, WAS SEEN TO HAVE 75% COVERAGE OF THE RIGHT RENAL (LOWEST RENAL) AND 25% OF THE LEFT RENAL. AT IMPLANT, NO COVERAGE WAS NOTED; THE CAUSE OF THE EVENT IS UNK. THERE WAS AN ELEVATED CREATININE. A RENAL BYPASS WAS PERFORMED WITHOUT ISSUES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE POST BYPASS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDURANT STENT GRAFT SYSTEM		MIH	MEDTRONIC CARDIOVASCULAR IRELAND	NA	V00853940

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Required Intervention