BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2920132 · Received January 9, 2013

    Report

    Report Number
    2017233-2013-00010
    Event Type
    Death
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. REFER TO THE FOLLOWING MEDWATCH # FOR THE REPORT INVOLVING THE GORE TRI-LOBE BALLOON CATHETER: 2017233-2013-00011.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT UNDERWENT TREATMENT OF A DISTAL THORACIC AORTIC ANEURYSM WITH A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED WITH NO ISSUE INTENTIONALLY COVERING THE CELIAC ARTERY. DURING ANGIOPLASTY OF THE PROXIMAL SEAL ZONE WITH A GORE TRI-LOBE BALLOON CATHETER, THE PT'S AORTA RUPTURED. IT WAS REPORTED THAT THE PT'S AORTA WAS VERY THIN AND FRIABLE. AN ATTEMPT WAS REPORTEDLY MADE TO CONVERT THE PT TO OPEN REPAIR, BUT THE PT EXPIRED. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS THE RUPTURE. AN AUTOPSY WAS NOT PERFORMED, AND THE DEVICES REMAIN IMPLANTED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11254 GORE TAG THORACIC ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES 10449950

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death DEPAKOTE| AMLODIPINE| MULTIVITAMIN| CLONIDINE| ASPIRIN| METOPROLOL| CITALOPRAM| PT MEDICATIONS INCLUDE: COMBVIENT