FDA Adverse Event Injury Summary report: N

TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

MDR report key: 1841620 · Received September 16, 2010

Report

Report Number: 2953200-2010-01759
Event Type: Injury
Date Received: September 16, 2010
Date of Event: August 17, 2010
Report Date: August 17, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR
Product Code: MIH
PMA / PMN Number: P070027
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION, RESULTS: (GRAFT MIGRATION, ENDOLEAK), (CONICAL AORTIC NECK WITH ANGULATION). CONCLUSION: (CONICAL AORTIC NECK WITH ANGULATION).

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 2 YEARS AGO. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. THE AORTIC NECK WAS CONICAL IN SHAPE, RANGING FROM 27 MM IN DIAMETER AT THE RENAL ARTERIES AND 36 MM IN DIAMETER AT 15 MM BELOW. THE NECK WAS ALSO ANGULATED 45 DEGREES LATERALLY AND THEN TOOK A 45 DEGREE TURN IN THE OTHER DIRECTION. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT HAD MIGRATED 4 MM DISTALLY AND HAD FALLEN INTO THE ANEURYSM SAC APPROXIMATELY ONE MONTH AGO, RESULTING IN A PROXIMAL TYPE I ENDOLEAK. THE MIGRATION WAS ATTRIBUTED TO THE NECK ANGULATION. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING TWO TALENT THORACIC 36 MM AORTIC CUFFS TO BUILD THE DEVICE UP FROM THE FLOW DIVIDER TO THE RENAL ARTERIES, WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK. 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	NA	V00183209

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Required Intervention