TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

Report

Report Number: 2953200-2010-01954
Event Type: Injury
Date Received: October 14, 2010
Date of Event: September 14, 2010
Report Date: September 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: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): EVAL RESULTS: (ENDOLEAK). (DISEASE PROGRESSION).

Description of Event or Problem · 1

AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM 113 MONTHS AGO. (MFR REPORT #2953200-2010-01876). THE AORTIC NECK IS 5 CM IN LENGTH. THE ANEURYSM WAS 6.5 CM IN DIAMETER AT TIME OF IMPLANT AND IN THE LEFT ILIAC ARTERY ,THERE WAS A 4.0 CM ANEURYSM. CURRENTLY, THE ABDOMINAL ANEURYSM IS SMALLER IN DIAMETER THAN AT THE TIME OF IMPLANT, IT IS 3.8 CM IN DIAMETER AND THE ILIAC ARTERY ANEURYSM IS GONE. THE VESSEL HAS REMODELED AND RESULTED IN STENT GRAFT MIGRATION. THERE IS ANOTHER ANEURYSM 3.5 CM IN DIAMETER ABOVE THE STENT GRAFT UP TO THE RENAL ARTERIES. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH AN ANEURX AORTIC CUFF. THE CUFF WAS IMPLANTED; HOWEVER, THERE WAS STILL A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN THEN IMPLANTED A TALENT AORTIC CUFF HOWEVER; THE ENDOLEAK STILL WAS NOT RESOLVED. (MFR 2953200-2010-01953). THE PT'S BLOOD PRESSURE DROPPED AND THE PHYSICIAN SUSPECTED A POSSIBLE RUPTURE, HOWEVER, THE PHYSICIAN CONVERTED THE PATIENT TO AN OPEN REPAIR AND FOUND THAT THERE WAS NOT A RUPTURE. THE CAUSE OF THE BLOOD PRESSURE DROPPING IS UNK. THE EXPLANTED STENT GRAFTS WERE DISCARDED BY THE USER FACILITY.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR