BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 5357868 · Received January 11, 2016

    Report

    Report Number
    2953200-2016-00066
    Event Type
    Death
    Date Received
    January 11, 2016
    Date of Event
    September 22, 2015
    Report Date
    December 17, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; OUTCOMES AFTER PARTIAL ENDOGRAFT EXPLANTATION. SEAN P. STEENBERGE, SEAN P. LYDEN, MD, ERIC J. TURNERY, MD, REBECCA L. KELSO, MD, SUNITA D. SRIVASTAVA, MD, MATTHEW J. EAGLETON, MD, DANIEL G. CLAIR, MD (ANNALS OF VASCULAR SURGERY 2015) 10.1016/J.AVSG.2015.09.018. A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM REPAIR. IT WAS REPORTED THAT AN AORTODUODENAL FISTULA (INFECTION) WITH DENSELY SCARRED TISSUE AROUND COMMON ILIAC ARTERIES WAS FOUND PRECLUDING COMPLETE EXPLANTATION. THE PHYSICIAN PERFORMED THE INTERVENTION AND DISTAL ANASTOMOSIS OF REPAIR AT COMMON ILIAC ARTERY ORIGINS WAS DONE. THE PATIENT EXPIRED FROM INTRAOPERATIVE FROM COAGULOPATHY AND HEMORRHAGE. ABSTRACT OBJECTIVE: TO EVALUATE THE ANEURYSM RELATED COMPLICATIONS AND DEVICE ISSUES IN PATIENTS WHO UNDERWENT PARTIAL ENDOGRAFT EXPLANTATION DURING LATE CONVERSION OF ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO OPEN REPAIR. MATERIAL AND METHODS: A RETROSPECTIVE ANALYSIS WAS PERFORMED ON PATIENTS WHO HAD PARTIALLY EXPLANTED ENDOGRAFTS DURING LATE CONVERSION BETWEEN 1999 AND 2012. MEDICAL RECORDS WERE REVIEWED FOR PATIENT DEMOGRAPHICS, SUBSEQUENT OPERATIONS, AND ANEURYSM RELATED COMPLICATIONS. POST-OPERATIVE ABDOMINAL X-RAY FILMS AND COMPUTED TOMOGRAPHY SCANS WERE ANALYZED FOR ENDOGRAFT MIGRATION, COMPONENT SEPARATION, DEVICE FRACTURE, AND ARTERIAL GROWTH OR ANEURYSM ISSUES. RESULTS: BETWEEN 1999 AND 2012, 22 PATIENTS HAD LATE CONVERSION AFTER EVAR WITH PORTIONS OF THE DEVICE LEFT IN SITU. FIVE OF THE PARTIALLY REMOVED DEVICES WERE ZENITH, SIX TALENT, FIVE ANCURE, THREE ANEURX, TWO EXCLUDER ENDOGRAFTS AND ONE COOK AUI GRAFT. THERE WERE FOUR IN HOSPITAL MORTALITIES. THERE WERE NO GRAFT MIGRATIONS, COMPONENT SEPARATIONS, DEVICE FRACTURES, NEW ANEURYSMAL DEGENERATION, OR RUPTURES WITH A MEDIAN FOLLOW UP OF 26.5 MONTHS. CONCLUSIONS: PARTIAL ENDOGRAFT REMOVAL DURING LATE CONVERSION IS NOT ASSOCIATED WITH COMPLICATIONS FROM THE REMAINING DEVICE PIECES DURING FOLLOW UP. WE RECOMMEND FURTHER STUDY OF THIS PATIENT POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17970 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R