TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

MDR report key: 1772389 · Received July 23, 2010

Report

Report Number: 2953200-2010-01384
Event Type: Injury
Date Received: July 23, 2010
Date of Event: June 25, 2010
Report Date: June 25, 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: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): RESULTS - ENDOLEAK; ANGULATED, REVERSE FUNNEL-SHAPED AORTIC NECK; PULLED THE STENT GRAFT DOWN.

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. ANEURYSM MORPHOLOGY WAS NOT REPORTED. THE AORTIC NECK WAS REVERSE FUNNEL-SHAPED WITH 45 DEGREES ANGULATION. IT WAS REPORTED THAT DURING THE REMOVAL OF THE DELIVERY CATHETER FOR THE TALENT BIFURCATED STENT GRAFT, THE PHYSICIAN INADVERTENTLY PULLED THE MAIN BODY DOWN, RESULTING IN A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO PLACE A TALENT AORTIC CUFF; HOWEVER, THERE WAS STILL A SLIGHT UNK ENDOLEAK PRESENT. NO FURTHER INTERVENTION WAS PERFORMED, AND THE ENDOLEAK LATER RESOLVED ON ITS OWN. 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 GALWAY	NA	V00477118

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Required Intervention