ANEURX ABDOMINAL STENT GRAFT

MDR report key: 2190878 · Received July 28, 2011

Report

Report Number: 2953200-2011-01345
Event Type: Injury
Date Received: July 28, 2011
Date of Event: June 27, 2011
Report Date: June 29, 2011
Manufacturer: MEDTRONIC CARDIOVASCULAR SANTA ROSA
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): EVALUATION, RESULTS: (MIGRATION). RESULTS AND CONCLUSIONS: (DISEASE PROGRESSION; AORTIC NECK DILATATION).

Description of Event or Problem · 1

AN ANEURX ABDOMINAL STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OVER SIX YEARS AGO. CURRENT VESSEL MORPHOLOGY WAS REPORTED AS MILD TO MODERATE CALCIFICATION AND TORTUOSITY; AN AORTIC NECK ANGULATION OF 45 DEGREES; A REVERSE FUNNEL SHAPE AORTIC NECK DIAMETER OF 25-28 MM. THE PATIENT HAD REFUSED TO COME IN FOR FOLLOW UP VISITS. ONE MONTH AGO, AT A FOLLOW-UP VISIT, THE CT SCAN SHOWED A PROXIMAL TYPE I ENDOLEAK, WITH A CAUDAL MIGRATION, SO THAT THE DEVICE WAS 35 MM FROM THE LOWEST RENAL ARTERY, DUE TO DISEASE PROGRESSION, AORTIC NECK DILATATION AND ANEURYSM EXPANSION. A 32 MM ENDURANT CUFF WAS PLACED. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANEURX ABDOMINAL STENT GRAFT		MIH	MEDTRONIC CARDIOVASCULAR SANTA ROSA	NA	271122

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR		Required Intervention