ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Report

Report Number: 2953200-2010-01165
Event Type: Death
Date Received: June 18, 2010
Date of Event: March 14, 2014
Report Date: November 11, 2014
Manufacturer: MEDTRONIC CARDIOVASCULAR
Product Code: MIH
PMA / PMN Number: P990020
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION RESULTS: (SHORT SEAL ZONE).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT EXPIRED, THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

Description of Event or Problem · 1

AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 57 MONTHS AGO. THERE IS A DISTANCE OF 2 CM FROM THE LEFT RENAL ARTERY WHICH IS HIGHER, TO THE LOWER RIGHT RENAL ARTERY. THE ANEURX STENT GRAFT WAS INITIALLY PLACED BELOW THE LOWEST RENAL ARTERY. IT WAS REPORTED THAT THE PT WAS EVALUATED AT ANOTHER INSTITUTION AND THE PHYSICIAN THERE NOTED THAT THE STENT GRAFT IS IN A SHORT PORTION OF THE AORTIC NECK; HOWEVER, THERE WAS NO ENDOLEAK OR MIGRATION. THE PHYSICIAN WAS NOT COMFORTABLE WITH THE FIXATION AND SEAL ZONE BELOW THE RIGHT RENAL ARTERY. THE DECISION WAS MADE TO PERFORM A TRANSPOSITION OF THE RIGHT RENAL ARTERY AND IMPLANT A TALENT CONVERTER AND AN OCCLUDER FOLLOWED BY A FEM-FEM BYPASS. THE PHYSICIAN FELT THIS WAS A MORE PERMANENT FIX. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC CARDIOVASCULAR	NA	720054

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR		Death\| R