ENDURANT ABDOMINAL STENT GRAFT SYSTEM

Report

Report Number: 2953200-2013-00121
Event Type: Injury
Date Received: January 18, 2013
Date of Event: December 21, 2012
Report Date: December 24, 2012
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION, ARTERIAL DISSECTION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERELY CALCIFIED ILIAC ARTERIES). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SEVERELY CALCIFIED ILIAC ARTERIES).

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.8 DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE PROXIMAL NECK WAS 21 MM IN DIAMETER AND 43 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 15 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 13 MM IN DIAMETER. THE VESSELS WERE SEVERELY CALCIFIED. AN ENDURANT BIFURCATED STENT GRAFT AND TWO ILIAC STENT GRAFT AN ENLW1610C124EJ AND AN ENEW1010C82EJ WERE IMPLANTED. ON THE FINAL ANGIOGRAM IT SHOWED THAT THE RIGHT CONTRALATERAL LIMB OCCLUDED AND A THERE WAS A DISSECTION OF THE ACCESS AREA. THE DISSECTION WAS TREATED. IT IS UNKNOWN IF THE OCCLUSION WAS TREATED. THE PHYSICIAN COMMENTED THE OCCLUSION WAS DUE TO THE SEVERE CALCIFICATION OF THE VESSELS WHERE THE CUT DOWN WAS DONE AND THAT IS THE LIKELY CAUSE OF THE OCCLUSION. THE OCCLUSION IS NOT RELATED TO THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
27843	ENDURANT ABDOMINAL STENT GRAFT SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	00070 YR		Required Intervention