FDA Adverse Event Malfunction Summary report: N

ENDURANT ABDOMINAL STENT GRAFT SYSTEM

MDR report key: 2073703 · Received April 13, 2011

Report

Report Number: 2953200-2011-00811
Event Type: Malfunction
Date Received: April 13, 2011
Date of Event: March 15, 2011
Report Date: March 15, 2011
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION, RESULTS: MODERATE TO SEVERE THROMBOSIS, MILD ANGULATION OF THE AORTIC NECK. EVALUATION, CONCLUSION: MODERATE TO SEVERE THROMBOSIS, MILD ANGULATION OF THE AORTIC NECK.

Description of Event or Problem · 1

AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM, APPROXIMATELY ONE MONTH AGO. THE PROXIMAL AORTIC NECK HAD MODERATE TO SEVERE THROMBOSIS, MILD ANGULATION AND NO CALCIFICATION. THE ILIAC ARTERIES HAD MILD CALCIFICATION BILATERALLY. IT WAS REPORTED THAT THE ENDURANT BIFURCATED STENT GRAFT WAS DEPLOYED DOWN TO THE END OF THE CONTRALATERAL LIMB. THE CONTRALATERAL LIMB ON THE BIFURCATED STENT GRAFT WAS KINKED, DUE TO VESSEL THROMBOSIS AND THE PHYSICIAN WAS UNABLE TO CANNULATE THE GATE. THE PHYSICIAN FULLY DEPLOYED THE IPSILATERAL LIMB AND THEN ADVANCED A GUIDEWIRE UP AND OVER THE BIFURCATION TO SNARE THE CONTRALATERAL LIMB DELIVERY CATHETER AND PULLED INTO THE CONTRALATERAL GATE. THE STENT GRAFT DEPLOYED WITHOUT ISSUE WITH THE LIMBS CROSSED. THE END RESULT WAS EXCELLENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDURANT ABDOMINAL STENT GRAFT SYSTEM		MIH	MEDTRONIC IRELAND	NA	V00814978

Patients

Seq	Age	Sex	Outcome	Treatment
1	87 YR