TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

MDR report key: 1760605 · Received July 14, 2010

Report

Report Number: 2953200-2010-01303
Event Type: Injury
Date Received: July 14, 2010
Date of Event: June 14, 2010
Report Date: June 14, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR
Product Code: MIH
PMA / PMN Number: P070027
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): RESULTS: (GRAFT MIGRATION), (DISEASE PROGRESSION AND SEVERE AORTIC NECK ANGULATION; TYPE II ENDOLEAK).

Description of Event or Problem · 1

A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 14 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW-UP APPROXIMATELY 1 MONTH AGO, AND THE CT DEMONSTRATED A TYPE II ENDOLEAK. AT THE TIME OF THE FOLLOW-UP, VESSEL MORPHOLOGY WAS REPORTED AS MILD TORTUOSITY AND MILD CALCIFICATION, AND THE AORTIC NECK WAS 30-31 MM IN DIAMETER AND HAD DISEASE PROGRESSION AND SEVERE ANGULATION OF 70 DEGREES. THE PHYSICIAN ELECTED TO PERFORM COILING, WHICH SUCCESSFULLY RESOLVED THE TYPE II ENDOLEAK. DURING THE INTERVENTION, IT WAS ALSO NOTED THAT THE TALENT BIFURCATED STENT GRAFT HAD MIGRATED DISTALLY ABOUT 8 MM, ALTHOUGH THERE WAS NO ENDOLEAK. THE PHYSICIAN ELECTED TO PLACE TWO 36 MM TALENT AORTIC CUFFS, WHICH SUCCESSFULLY RESOLVED THE MIGRATION. NO ADDITIONAL 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	NA	V00206796

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Required Intervention