BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL EXTENSION CUFF

    MDR report key: 2000437 · Received February 18, 2011

    Report

    Report Number
    2953200-2011-00454
    Event Type
    Death
    Date Received
    February 18, 2011
    Date of Event
    January 3, 2005
    Report Date
    January 19, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS: (ENDOLEAK, DEATH).

    Description of Event or Problem · 1

    AN ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT 72 MONTHS AGO THE ANEURYSM MEASURES 63 MM IN DIAMETER AND THE AORTIC NECK DIAMETER HAS INCREASED FROM 22 MM TO 27 MM IN DIAMETER. IT WAS REPORTED THAT DUE TO A TYPE 2 ENDOLEAK, THE PATIENT HAD A SUCCESSFUL COIL EMBOLIZATION PROCEDURE DONE. A FEW MONTHS LATER, A CT REVEALED THAT THE STENT GRAFT MIGRATED DISTALLY AND A SMALL TYPE I ENDOLEAK WAS PRESENT. THE PHYSICIAN REQUESTED A TALENT AORTIC CUFF AS A COMPASSIONATE USE FOR TREATMENT FOR THIS PATIENT. THE TALENT CUFF WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. (REF MFR# 2953200-2004-01124). ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT THE PATIENT HAD OPEN REPAIR ON 60 MONTHS AFTER THE SECONDARY INTERVENTION DUE TO A RUPTURING ANEURYSM. IT WAS REPORTED THAT THE RUPTURE WAS RELATED TO A SIGNIFICANT TYPE 3 ENDOLEAK SEPARATION OF ANOTHER MANUFACTURER'S STENT GRAFT AND A TALENT EXTENSION CUFF. IT WAS NOT POSSIBLE TO PERFORM ENDOVASCULAR REPAIR. IT WAS REPORTED THAT THE PATIENT LATER EXPIRED 18 MONTHS LATER OF UNKNOWN CAUSES. (REF MFR# 2953200-2011-00455 AND 2953200-2011-00456). PLEASE NOTE THAT THIS DEVICE (B)(4) IS SIMILAR TO A UNITED STATES DISTRIBUTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL EXTENSION CUFF NONE MIH MEDTRONIC CARDIOVASCULAR NA 139780

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R