BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HEMOBAHN ENDOPROSTHESIS

    MDR report key: 2070297 · Received April 18, 2011

    Report

    Report Number
    2017233-2011-00198
    Event Type
    Injury
    Date Received
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    REVIEW OF A LITERATURE ARTICLE REVEALED 1 CASE REPORT ASSOCIATED WITH HEMOBAHN. A HEMOBAHN DEVICE WAS IMPLANTED IN A (B)(6) PT WITH ABDOMINAL AORTIC ANEURYSM. POST DEVICE IMPLANT, INCREASING ANEURYSM DIAMETER SAC HYGROMA WAS DIAGNOSED. SAC HYGROMA WAS DIAGNOSED AS THE CAUSE FOR INCREASING ANEURYSM DIAMETER DOCUMENTED ON SPIRAL COMPUTED TOMOGRAPHY (CT). THE DIAGNOSIS OF SAC HYGROMA WAS MADE BASED ON THE LACK OF A DEMONSTRABLE ENDOLEAK ON CT IMAGING, THE PRESENCE OF A GELATINOUS, CLEAR FLUID IN THE SAC, AND A NON-PULSATILE SAC PRESSURE THAT WAS ABOUT ONE THIRD OF THE SYSTEMIC BLOOD PRESSURE. THE PT WAS FOLLOWED AT REGULAR INTERVALS WITH SPIRAL CT AND PERCUTANEOUS CT-GUIDED TRANS-LUMBAR INTRA-SAC PRESSURE MEASUREMENTS. SURGICAL INTERVENTION WAS PERFORMED WITH A LARGE FENESTRATION IN THE ANEURYSM SAC, PARTLY RESECTING THE ANEURYSM WALL. THE FLUID REMOVED FROM THE SAC WAS TRANSLUCENT, WHITISH, SEMI-LIQUID, GELATINOUS, AND VISCOUS. HOWEVER, THE OPEN FENESTRATION DID NOT PREVENT HYGROMA RECURRENCE. THE ANEURYSM DIAMETER REMAINED UNCHANGED DURING THE OBSERVATION PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HEMOBAHN ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG320

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention