FDA Adverse Event Injury Summary report: N

TALENT THORACIC STENT GRAFT SYSTEM

MDR report key: 1101747 · Received August 7, 2008

Report

Report Number
2953200-2008-00662
Event Type
Injury
Date Received
August 7, 2008
Report Date
July 16, 2008
Manufacturer
MEDTRONIC CARDIOVASCULAR
Product Code
MIH
PMA / PMN Number
P070007
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GM
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A CHRONIC FALSE THORACIC ANEURYSM DUE TO A PREVIOUS THORACIC REPAIR 33 YEARS AGO. THIS EVENT WAS REPORTED IN THE JOURNAL OF VASCULAR SURGERY 2008; 47: 1195-1202, JUNE 2008. THE STENT GRAFTS WERE IMPLANTED BETWEEN 2001 AND 2007. IT WAS REPORTED THE PATIENT HAD A TYPE 1A ENDOLEAK AND A RECURRING CEREBRAL EMBOLIZATION OWING TO PROXIMAL STENT MIGRATION INTO THE OSTIUM OF THE LEFT CAROTID ARTERY AND HEMOPTYSIS CAUSED BY AN AORTOBRONCHIAL FISTULA. THIS PATIENT HAD PREVIOUSLY UNDERGONE SEVERAL PROCEDURES, INCLUDING A LEFT THORACOTOMY AND AORTIC PATCH PLASTY FOR A FALSE ANEURYSM AFTER TRAUMATIC ISTHMUS RUPTURE. THE PATIENT PRESENTED 33 YEARS LATER WITH PARALYSIS OF THE LEFT RECURRENT PATCH, WHICH WAS TREATED WITH A THORACIC ENDOGRAFT. THREE YEARS LATER THE PATIENT WAS REFERRED WITH CEREBRAL EMBOLIZATIONS AND HEMOPTYSIS. THE ENTIRE DEVICE HAD MIGRATED PROXIMALLY AND THE BARE STENT PROTRUDED IN THE OSTIUM OF THE LEFT CAROTID ARTERY CAUSING RECURRENT EMBOLIZATIONS. IN ADDITION THERE WAS A LARGE PROXIMAL TYPE 1 ENDOLEAK AND AN AORTOBRONCHIAL FISTULA. THE PATIENT REFUSED FURTHER ENDOVASCULAR REPAIR BECAUSE THIS WOULD INDICATE STERNOTOMY WITH DEBRANCHING OF THE SUPRA-AORTIC VESSELS AND EXTENSION OF THE ENDOGRAFT. THE PATIENT WAS TREATED BY ELECTIVE CONVERSION PROCEDURE INVOLVING HEMI ARCH AND DESCENDING AORTIC REPLACEMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WAS DISCHARGED.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 47 YR Required Intervention