ANEURX ILIAC EXT CUFF SG W/XCELERANT DEL SYSTEM

MDR report key: 5215334 · Received November 10, 2015

Report

Report Number: 2953200-2015-01954
Event Type: Death
Date Received: November 10, 2015
Date of Event: October 17, 2015
Report Date: October 17, 2015
Manufacturer: MEDTRONIC CARDIOVASCULAR SANTA ROSA
Product Code: MIH
PMA / PMN Number: P990020
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD PRESENTED EMERGENTLY WITH A CONTAINED ANEURYSM RUPTURE. AT THAT TIME THE PHYSICIAN STATED THAT ON CT IT WAS THOUGHT THERE WAS A FRACTURE IN THE ILIAC LIMB ON LEFT SIDE THAT CAUSED THE RUPTURE. THE DECISION WAS MADE TO TREAT THE PATIENT. ACCESS WAS OBTAINED AND AN ANGIOGRAM REVEALED THAT THERE WAS NO STENT FRACTURE AND THE LEFT ILIAC HAD BECOME ANEURYSMAL DISTAL TO STENT GRAFT AND HAD RUPTURED. A 16X13X156 ENDURANT STENT GRAFT WAS PLACED IN THE EXISTING GRAFT EXTENDING INTO LEFT EXTERNAL ILIAC. THIS SUCCESSFULLY STOPPED THE LEAKING ANEURYSM. THE PHYSICIAN NOTED ON ANGIOGRAM THAT THE RIGHT ILIAC ARTERY HAD BECOME ANEURYSMAL DISTAL TO THE STENT GRAFT ALSO, SO EXTENDED INTO THE RIGHT EXTERNAL WITH A 16X13X93 ENDURANT STENT GRAFT. THE PATIENT REFUSED BLOOD PRODUCTS AND IN POST-OP DEVELOPED SEVERE ANEMIA. THE PATIENT HAD A CARDIAC ARREST AND EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
745822	ANEURX ILIAC EXT CUFF SG W/XCELERANT DEL SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC CARDIOVASCULAR SANTA ROSA	YRIRHXC16115

Patients

Seq	Age	Sex	Outcome	Treatment
1	00091 YR		Death\| R