MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

MDR report key: 1884615 · Received October 19, 2010

Report

Report Number: 2953200-2010-01996
Event Type: Injury
Date Received: October 19, 2010
Date of Event: September 21, 2010
Report Date: September 21, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR
Product Code: MIH
PMA / PMN Number: P990020
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): RESULTS: (MIGRATION, ENDOLEAK), (DISEASE PROGRESSION WITH VESSEL TORTUOSITY).

Description of Event or Problem · 1

AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 111 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNK. CURRENTLY, THE ILIAC VESSELS WERE REPORTED TO BE SEVERELY TORTUOUS. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED THAT THE BIFURCATED STENT GRAFT HAS MIGRATED 15 CM DISTALLY, RESULTING IN A TYPE III (JUNCTIONAL SEPARATION) ENDOLEAK BETWEEN THE BIFURCATED STENT GRAFT AND THE DISTAL AORTIC CUFF (MFR REPORT #2953200-2010-01997). AT THE TIME OF THE EVENT, THE AORTIC NECK WAS ANGULATED ANTERIORLY 20 DEGREES AND REVERSE FUNNEL SHAPED, AND THE CAUSE OF THE MIGRATION WAS ATTRIBUTED TO DISEASE PROGRESSION AND VESSEL TORTUOSITY. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING A TALENT CONVERTER AND AN OCCLUDER AND THEN PERFORMED A FEMORAL-TO-FEMORAL BYPASS SUCCESSFULLY. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)		MIH	MEDTRONIC CARDIOVASCULAR	NA	M01C750925

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR		Required Intervention