TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT

Report

Report Number: 2953200-2011-00163
Event Type: Death
Date Received: January 21, 2011
Date of Event: December 22, 2010
Report Date: December 22, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: MIH
PMA / PMN Number: P070007
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). EVAL RESULTS: (ENDOLEAK, DEATH), (TORTUOUS AORTA AND DIFFICULT DISTAL LANDING ZONE). CONCLUSIONS: (TORTUOUS AORTA AND DIFFICULT DISTAL LANDING ZONE).

Description of Event or Problem · 1

A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROX 4 MONTHS AGO. ANEURYSM MORPHOLOGY FROM THE TIME OF IMPLANT WAS NOT REPORTED. THE AORTA WAS TORTUOUS AND THE DISTAL LANDING ZONE WAS DESCRIBED AS DIFFICULT. IT WAS REPORTED THAT A TYPE 1 ENDOLEAK WAS IDENTIFIED RECENTLY DURING A ROUTINE F/U; HOWEVER, THE LOCATION OF THE ENDOLEAK COULD NOT BE IDENTIFIED AS PROXIMAL OR DISTAL. IT WAS ALSO NOTED THAT THERE MAY BE A MISALIGNED PROXIMAL SPRING SEEN AT THIS F/U VISIT AND THIS WAS NOT CLEARLY SEEN AT THE TIME OF IMPLANT. AN INTERVENTION TO SEAL THE GRAFTS PROXIMALLY AND DISTALLY IS PLANNED AT A LATER DATE (SEE MFR # 2953200-2010-02447 AND MFR # 2953200-2010-02448). IT WAS REPORTED THAT THE PT WAS TREATED APPROX ONE MONTH AFTER INITIAL IMPLANT WITH A 46X46 TALENT CAPTIVA AND A DISTAL EXTENSION, SUCCESSFULLY RESOLVING THE LEAK. THE PT WAS EXPERIENCING DISSEMINATED INTRAVASCULAR COAGULATION AND EXPIRED. THE PHYSICIAN WAS AT THE AUTOPSY AND NOTED THAT THERE WERE NO ENDOLEAKS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT		MIH	MEDTRONIC CARDIOVASCULAR GALWAY	NA	V00456700

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Death