ENDURANT ABDOMINAL STENT GRAFT SYSTEM

MDR report key: 2050884 · Received April 1, 2011

Report

Report Number: 2953200-2011-00733
Event Type: Injury
Date Received: April 1, 2011
Date of Event: March 2, 2011
Report Date: March 2, 2011
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: (ARTERIAL OCCLUSION). RESULTS & CONCLUSIONS: (SMALL DIAMETER VESSELS DISTAL TO THE STENT GRAFT LIMB).

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.0 CM DIAMETER ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2011. THE NECK DIAMETER WAS 21 MM PROXIMALLY AND DISTALLY. THE LCIA WAS 9 MM IN DIAMETER AND THERE WAS POOR FLOW LUMEN TO BEGIN WITH. IT WAS REPORTED THAT THE PT PRESENTED WITH AN OCCLUDED LCIA ON (B)(6) 2011. THE OCCLUSION EXTENDED FROM THE AORTIC BIFURCATION ON THE LEFT ALL THE WAY DOWN THE TAKE OFF OF THE SFA ON THE LEFT SIDE. CURRENTLY, THE LCIA LUMEN IS 5 - 6 MM IN DIAMETER. THE DECISION WAS MADE TO THROMBOLIZE THE LCIA WITH A FOGARTY CATHETER AND TO PLACE A BALLOON EXPANDABLE STENT TO KEEP IT OPEN. THE PT WAS BROUGHT BACK THE NEXT DAY AND THROMBUS WAS REMOVED WITH A BALLOON THROMBECTOMY CATHETER. THE RIGHT AND LEFT COMMON ILIAC ARTERIES WERE STENTED WITH A 10 MM DIAMETER BALLOON EXPANDABLE STENTS. THE LEFT EXTERNAL ILIAC ARTERY WAS STENTED WITH SELF EXPANDING STENTS AND POST DILATED WITH A 10 MM BALLOON (SEE MFR #2953200-2011-00734). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDURANT ABDOMINAL STENT GRAFT SYSTEM		MIH	MEDTRONIC IRELAND	NA	V00561700

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Required Intervention