MEDTRONIC ANEURX (FLEXIBLE) STENT GRAFT SYSTEM

MDR report key: 2191211 · Received July 29, 2011

Report

Report Number: 2953200-2011-01364
Event Type: Injury
Date Received: July 29, 2011
Date of Event: July 2, 2011
Report Date: January 25, 2012
Manufacturer: MEDTRONIC CARDIOVASCULAR
Product Code: MIH
PMA / PMN Number: P990020
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

RESULTS: OPEN SURGICAL REPAIR.

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: (STENT GRAFT MIGRATION). RESULTS AND CONCLUSION: (DISEASE PROGRESSION; NECK DILATATION).

Description of Event or Problem · 1

ADDITIONAL INFORMATION HAS BEEN RECEIVED: IT WAS REPORTED THAT THE PATIENT HAD AN OPEN REPAIR PERFORMED. THE SURGICAL CONVERSION WAS SUCCESSFUL AND THE PATIENT IS FINE. EXACT DATE OF INTERVENTION AND NATURE OF THE OPEN REPAIR ARE UNKNOWN.

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 9 YRS AGO. VESSEL AND ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. CURRENTLY, THE VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS DISEASE PROGRESSION WITH AORTIC NECK DILATATION. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED DISTALLY WITHOUT A TYPE I ENDOLEAK. THE PT IS SCHEDULED TO BE TREATED AT A LATER DATE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MEDTRONIC ANEURX (FLEXIBLE) STENT GRAFT SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC CARDIOVASCULAR	NA	M02E550169

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention