TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

MDR report key: 1760732 · Received July 15, 2010

Report

Report Number: 2953200-2010-01322
Event Type: Injury
Date Received: July 15, 2010
Date of Event: May 1, 2010
Report Date: June 16, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: MIH
PMA / PMN Number: P070027
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVAL RESULTS: GRAFT OCCLUSION. SEVERE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION.

Description of Event or Problem · 1

A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 2 MONTHS AGO. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSELS HAD SEVERE TORTUOSITY AND SEVERE CALCIFICATION. THE EXTERNAL ILIAC ARTERY WAS 9 MM IN DIAMETER. IT WAS REPORTED THAT AN ANEURX CONTRALATERAL LIMB (MFR REPORT # 2953200-2010-01323) AND A TALENT BIFURCATED STENT GRAFT WERE IMPLANTED WITH THE LIMBS UNCROSSED. APPROX 1 WEEK POST-IMPLANTATION, THE PT PRESENTED WITH LEG PAIN, AND THE CT DEMONSTRATED THAT THE IPSILATERAL LIMB OF THE BIFURCATED STENT GRAFT AND THE CONTRALATERAL ANEURX LIMB WERE BOTH KINKED AND OCCLUDED. THE KINK AND OCCLUSION WERE WHERE THE TWO STENT GRAFTS JOINED, AND MAY HAVE BEEN CAUSED BY THE SEVERE VESSEL TORTUOSITY. THE PHYSICIAN ELECTED TO PERFORM A FEMORAL-FEMORAL BYPASS, WHICH SUCCESSFULLY RESOLVED THE OCCLUSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO		MIH	MEDTRONIC CARDIOVASCULAR GALWAY	NA	V00475161

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Required Intervention