BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2826313 · Received October 30, 2012

    Report

    Report Number
    2017233-2012-00739
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    February 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE CAUSE OF THE MALAPPOSITION IS UNKNOWN. RIESENMAN PJ, BROOKS JD, FARBER MA. ACUTE BLUNT TRAUMATIC INJURY TO THE DESCENDING THORACIC AORTA. JOURNAL OF VASCULAR SURGERY 2012; 56(5); 1274-1280.

    Description of Event or Problem · 1

    AN ARTICLE IN THE JOURNAL OF VASCULAR SURGERY REVIEWED OUTCOMES OF PATIENTS WHO SUSTAINED ACUTE BLUNT DESCENDING THORACIC AORTIC INJURY BETWEEN (B)(6) 1990 AND (B)(6) 2010. OF THE 100 PATIENTS IDENTIFIED OVER THE 20-YEAR STUDY PERIOD, 60 (60%) UNDERWENT CONVENTIONAL OPEN REPAIR, 26 (26%) UNDERWENT ENDOVASCULAR REPAIR, AND 14 (14%) DID NOT UNDERGO AN AORTIC INTERVENTION. THIS ARTICLE DESCRIBES A PATIENT WHO RECEIVED A TAG DEVICE THAT WAS DEPLOYED SUCCESSFULLY AT THE TIME OF THE PRIMARY PROCEDURE BUT WAS FOUND TO BE MALAPPOSED ON POST-OPERATIVE DAY 3. THIS PATIENT WAS TREATED WITH A TALENT DEVICE IN A SIMILAR FASHION TO OUR OTHER PATIENT WHO EXPERIENCED THE SAME COMPLICATION AT THE TIME OF THEIR PRIMARY INTERVENTION. IT WAS REPORTED IN THE ARTICLE THAT THE MEAN AGE WAS 39.5(+/- 20.1) YEARS AND 68% OF THE PATIENTS WERE MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R