TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

MDR report key: 1760621 · Received July 14, 2010

Report

Report Number: 2953200-2010-01310
Event Type: Injury
Date Received: July 14, 2010
Date of Event: June 14, 2010
Report Date: June 14, 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: IL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): EVALUATION RESULTS: (DISSECTION), (NARROW VESSELS; MODERATE TO SEVERE VESSEL CALCIFICATION).

Description of Event or Problem · 1

A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSEL MORPHOLOGY WAS REPORTED AS MILD TORTUOSITY AND MODERATE TO SEVERE CALCIFICATION, AND THE ILIAC ARTERIES WERE 8 MM IN DIAMETER ON THE RIGHT SIDE AND 7 MM IN DIAMETER ON THE LEFT SIDE. THE AORTIC NECK ANGULATION WAS 15 DEGREES. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE TALENT DELIVERY SYSTEM THROUGH THE LEFT SIDE TO THE INTENDED LANDING AREA AND DURING THAT ATTEMPT, A DISSECTION IN THE LEFT ILIAC/COMMON ILIAC ARTERY BIFURCATION WAS NOTED. THE DEVICE WAS REMOVED FROM THE PATIENT AND DISCARDED BY THE USER FACILITY. THE PHYSICIAN ELECTED TO IMPLANT TWO 12 MM ANEURX ILIAC LIMBS TO COVER THE DISSECTION AND THEN WAS ABLE TO DELIVER AND IMPLANT AN ANEURX BIFURCATED STENT GRAFT TO COMPLETE THE CASE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT 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	V00439062

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention