ANEURX STENT GRAFT SYSTEM

Report

Report Number: 2953200-2012-02132
Event Type: Injury
Date Received: November 6, 2012
Date of Event: October 11, 2012
Report Date: October 11, 2012
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P990020
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; DISEASE PROGRESSION AND SEVERE AORTIC NECK ANGULATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; DISEASE PROGRESSION AND SEVERE AORTIC NECK ANGULATION).

Description of Event or Problem · 1

AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. CURRENTLY THERE IS DISEASE PROGRESSION AND SEVERE AORTIC NECK ANGULATION, 75 DEGREE. IT WAS REPORTED FIVE YEARS POST IMPLANT THE PATIENT WAS TREATED WITH AN AEXCH282840 AND AN AXF3434W28XH DUE TO MIGRATION AND A TYPE I ENDOLEAK OF THE BIFURCATED STENT GRAFT. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED THAT THERE WAS A TYPE III SEPARATION BETWEEN THE ANEURX AND TALENT CUFFS THAT WERE IMPLANTED, DUE TO THE CONTINUED DISEASE PROGRESSION AND ANGULATION OF THE AORTIC NECK. A PALMAZ STENT WAS IMPLANTED; HOWEVER, IT WAS THE UNDERSIZED. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT CUFF, JAILING THE PALMAZ STENT AGAINST THE VESSEL WALL. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANEURX STENT GRAFT SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V00539544

Patients

Seq	Age	Sex	Outcome	Treatment
1	00070 YR		Required Intervention