TALENT ABDOMINAL STENT GRAFT SYSTEM (COILTRAC)

Report

Report Number: 2953200-2010-01313
Event Type: Injury
Date Received: July 14, 2010
Date of Event: June 15, 2010
Report Date: June 15, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR
Product Code: MIH
PMA / PMN Number: P070027
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): EVAL, RESULTS: (ENDOLEAK). (LIMB PLACEMENT WAS SHORT IN THE ILIAC ARTERY). CONCLUSION: (LIMB PLACEMENT WAS SHORT IN THE ILIAC ARTERY).

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 APPROX 21 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. AT THE TIME OF THE INITIAL IMPLANT, THE CONTRALATERAL AND IPSILATERAL LIMBS WERE BOTH PLACED INTO THE COMMON ILIAC ARTERIES BY ONLY ABOUT 1.5 CM. IT WAS REPORTED THAT APPROXIMATELY 1 MONTH AGO, THE PT PRESENTED EMERGENTLY WITH ABDOMINAL AND BACK PAIN. AT THE TIME OF THE EVENT, THE ANEURYSM WAS 5.5-6 CM IN DIAMETER, AND THE AORTIC NECK AND VESSELS WERE UNREMARKABLE. A DISTAL TYPE I ENDOLEAK WAS NOTED ON THE LEFT/CONTRALATERAL SIDE. THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING AN ANEURX EXTENSION GRAFT DISTALLY. ALSO, BECAUSE THE IPSILATERAL LIMB (MFR REPORT # 2953200-2010-01314) WAS SHORT IN THE ILIAC ARTERY AT THE TIME OF IMPLANT, THE PHYSICIAN ADDED AN ANEURX EXTENSION AS A PROPHYLACTIC MEASURE, EVEN THOUGH NO ENDOLEAK WAS NOTED. NO ADD'L 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 (COILTRAC)		MIH	MEDTRONIC CARDIOVASCULAR	NA	V00125691

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Required Intervention