ENDURANT ABDOMINAL STENT GRAFT SYSTEM

MDR report key: 2251419 · Received September 13, 2011

Report

Report Number: 2953200-2011-01572
Event Type: Injury
Date Received: September 13, 2011
Date of Event: August 15, 2011
Report Date: August 15, 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: AS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVAL, RESULTS: (ENDOLEAK), (CAUSE OF EVENT IS UNK). CONCLUSIONS: (CAUSE OF EVENT IS 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. ANEURYSM AND VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT A BIFURCATED STENT GRAFT WAS PLACED AS PLANNED WITH A CONTRALATERAL LIMB AS A DISTAL EXTENSION INTO THE RIGHT EXTERNAL ILIAC ARTERY. THE RIGHT INTERNAL ILIAC ARTERY HAD PREVIOUSLY BEEN COILED. ON THE FINAL RUN THERE APPEARED TO BE A LEAK IN THE GRAFT IN THE RIGHT COMMON ILIAC ARTERY REGION JUST PROXIMAL TO THE COILED INTERNAL WHERE THE OVERLAP OF THE IPSILATERAL LIMB OF THE BIFURCATED GRAFT WAS AND THE DISTAL EXTENSION. (MFR REPORT# 2953200-2011-01572, 2953200-2011-01573) THE STENT GRAFT WAS RE-BALLOONED BUT THIS DID NOT IMPROVE THE LEAK. THE AREA WAS RE-LINED WITH ANOTHER STENT GRAFT OF THE SAME SIZE AND THE LEAK RESOLVED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. AN INTERNAL REVIEW OF THE RETURNED FILMS SHOW AND ENDOLEAK IN THE AREA NEAR THE JUNCTION OF THE IPSILATERAL AND IPSILATERAL EXTENSION; TYPE AND CAUSE COULD NOT BE DETERMINED. AFTER RE-LINING THE ENDOLEAK APPEARED TO HAVE RESOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDURANT ABDOMINAL STENT GRAFT SYSTEM		MIH	MEDTRONIC CARDIOVASCULAR IRELAND	NA	V00903100

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR		Required Intervention