ENDURANT

Report

Report Number: 2953200-2014-01147
Event Type: Injury
Date Received: June 6, 2014
Date of Event: May 16, 2014
Report Date: May 16, 2014
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 42 MM ABDOMINAL AORTIC ANEURYSM. THE DIAMETER OF THE PROXIMAL NECK WAS 19 MM, AND THE LENGTH WAS 33 MM. THE DIAMETER OF THE TERMINAL AORTA WAS 16.2 X 14.7 MM, AND A CALCIFIED LESION WAS PRESENT IN THIS AREA. THE RIGHT ILIAC WAS 11 MM IN DIAMETER, AND THE LEFT WAS 11 MM IN DIAMETER. THERE WAS A REVERSE DOG-LEG BEND IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY. THE ACCESS VESSELS WERE 9 MM IN DIAMETER. THE PROCEDURE WAS SUCCESSFUL WITH NO ISSUES NOTED. IT WAS REPORTED THAT AT 5 MONTHS POST-IMPLANT, THE PATIENT¿S ABI WAS DETERMINED TO BE 0.84. AT THE ONE YEAR FOLLOW-UP VISIT, THE ABI WAS DETERMINED TO BE 0.59. THE PATIENT WAS URGENTLY TAKEN TO SURGERY AND IT WAS CONFIRMED THAT THE RIGHT CONTRALATERAL LIMB HAD BECOME THROMBOSED. A THROMBECTOMY WAS PERFORMED AND A BARE METAL STENT WAS IMPLANTED. ADEQUATE BLOOD FLOW WAS CONFIRMED THROUGH THE STENT GRAFT WITH GOOD PULSES IN THE RIGHT LOWER EXTREMITY. THE PHYSICIAN COMMENTED THAT THE PATIENT WAS AT RISK FOR LIMB OCCLUSION DUE TO THE ANATOMY OF THE TERMINAL AORTA AND RIGHT COMMON ILIAC ARTERY, AND IT IS BELIEVE THAT THE OCCLUSION WAS DUE TO THE PATIENT¿S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
333159	ENDURANT	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V03989294

Patients

Seq	Age	Sex	Outcome	Treatment
1	00082 YR		Required Intervention