BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HEMOBAHN ENDOPROSTHESIS

    MDR report key: 3037490 · Received March 28, 2013

    Report

    Report Number
    2017233-2013-00187
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 28, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS FROM THE FOLLOWING LITERATURE ARTICLE: HOUTHOOFD S, YAZAR O, TOPAL H. DAENENS K, FOURNEAU I. STENT GRAFT INFECTION IN THE LOWER LIMB. ACTA CHIRUGICA BELGICA 2012; 112(6): 441-443. H6: NO LOT NUMBER INFORMATION WAS SUPPLIED; THEREFORE, NO REVIEW OF THE MANUFACTURING PAPERWORK COULD BE PERFORMED. THE DEVICE WAS NOT RETURNED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. WITHOUT ADDITIONAL INFORMATION IT IS IMPOSSIBLE TO FURTHER INVESTIGATE THIS EVENT.

    Description of Event or Problem · 1

    IN THE MEDICAL LITERATURE IT WAS STATED THAT IN 2005, A PATIENT WAS IMPLANTED WITH A GORE HEMOBAHN ENDOPROSTHESIS FOR AN ANEURYSM IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE ARTICLE STATED THAT IN (B)(6) 2007, THE PATIENT PRESENTED WITH THROMBOSIS OF THE STENT GRAFT. THROMBECTOMY AND THROMBOLYSIS OF THE STENT GRAFT. THROMBECTOMY AND THROMBOLYSIS PROCEDURES WERE PERFORMED. ONE YEAR LATER, THE PATIENT RETURNED WITH ACUTE ISCHEMIA OF THE LEFT LIMB. A BELOW-THE-KNEE AMPUTATION WAS PERFORMED. THE AMPUTATION HAD TO BE EXTENDED TWICE BUT REMAINED INFERIOR TO THE KNEE. TWO MONTHS POSTOPERATIVELY, A TRANSARTICULAR KNEE AMPUTATION WAS PERFORMED. AFTER TWO MONTHS, THE PATIENT PRESENTED WITH TWO WOUNDS ON THE DORSAL SITE OF HIS UPPER LEG WITH INFECTION. THE INFECTION WAS MEDICALLY TREATED. AFTER SIX MONTHS, THE FISTULA STILL PERSISTED. CT SCAN REVEALED AN OCCLUSION OF THE HEMOBAHN IN THE SFA AND AIR BUBBLES AROUND THE STENT GRAFT. SURGICAL EXPLORATION REVEALED A CONNECTION BETWEEN THE PROXIMAL FISTULA AND THE SFA. PUS WAS DRAINED AFTER THE TRANSECTION OF THE ARTERY. THE STENT GRAFT WAS REMOVED USING A RING STRIPPER. PATIENT WAS MEDICALLY TREATED AND THE WOUND HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129565 GORE HEMOBAHN ENDOPROSTHESIS NA MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention