TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

Report

Report Number: 2953200-2011-00876
Event Type: Injury
Date Received: April 22, 2011
Date of Event: March 25, 2011
Report Date: March 25, 2011
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P070027
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: (STENT GRAFT MIGRATION, ENDOLEAK). RESULTS & CONCLUSION: (DISEASED AND ELONGATED AORTIC NECK).

Description of Event or Problem · 1

A TALENT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX FOUR MONTHS AGO. ANEURYSM MORPHOLOGY AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. CURRENTLY, THE ANEURYSM IS 6 CM IN DIAMETER AND THERE WAS DISEASE PROGRESSION AND ELONGATION OF THE AORTIC NECK. A RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED APPROX 12 MM DISTAL TO THE RENAL ARTERIES WITH A TYPE I ENDOLEAK PRESENT. IT WAS ALSO NOTED THAT THERE IS LOSS OF SEAL ZONE OF THE CONTRALATERAL ILIAC LIMB WITH NO APPOSITION BETWEEN THE STENT GRAFT AND THE VESSEL WALL, HOWEVER, THERE WAS NO ENDOLEAK NOTED (REF MFR # 2953200-2011-00877). THERE WAS ALSO A SLIGHT KINK IN THE CONTRALATERAL ILIAC STENT GRAFT AND ARTERY. THE CAUSE OF THE SEAL LOSS IN THE DISTAL AREA IS MOST LIKELY RELATED TO THE ELONGATION OF THE AORTIC NECK, WHICH RESULTED IN THE CHANGE IN THE ILIAC TORTUOSITY AND KINK OF THE ILIAC ARTERY. THE PT MAY BE TREATED IN THE NEXT FEW WEEKS; HOWEVER, NO FURTHER INFO WAS PROVIDED. NO ADD'L 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 IRELAND	NA	V00461832

Patients

Seq	Age	Sex	Outcome	Treatment
1	87 YR		Required Intervention