BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 6889770 · Received September 25, 2017

    Report

    Report Number
    2017233-2017-00494
    Event Type
    Injury
    Date Received
    September 25, 2017
    Date of Event
    January 1, 2017
    Report Date
    October 9, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHED THE ARTICLE (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). LOT/SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    WITHIN THE ARTICLE ¿SECONDARY PROCEDURES FOLLOWING ILIAC BRANCH DEVICE TREATMENT OF ANEURYSMS INVOLVING THE ILIAC BIFURCATION: THE PELVIS REGISTRY¿, PUBLISHED BY KONSTANTINOS P. DONAS ET AL, WITHIN THE JOURNAL OF ENDOVASCULAR THERAPY, 2017, VOL. 24(3) 405¿410, THE PUBLISHED RESULTS INDICATED THE FOLLOWING: BETWEEN JANUARY 2005 AND DECEMBER 2015, 575 SURGICAL-HIGH-RISK PATIENTS WITH ISOLATED ILIAC ANEURYSMS (N=79) OR AORTOILIAC ANEURYSMS INVOLVING THE ILIAC BIFURCATION (N=496) WERE TREATED WITH PLACEMENT OF 650 ZBIS ILIAC BRANCH DEVICES (IBDS) OR GORE IBDS (75 BILATERAL) IN 6 EUROPEAN CENTERS. THE MAJORITY (546) OF PATIENTS UNDERWENT PLACEMENT OF A ZBIS IBD (COOK MEDICAL, (B)(4)); 29 HAD IMPLANTATION OF A GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (W.L. GORE & ASSOCIATES, (B)(4)). BALLOON-EXPANDABLE (N=557) OR SELF-EXPANDING (N=211) COVERED STENTS WERE USED AS BRIDGING DEVICES, INCLUDING ATRIUM ADVANTA V12 (MAQUET GETINGE GROUP, (B)(4)), VIABAHN (W.L. GORE & ASSOCIATES; N=60), FLUENCY (BARD PERIPHERAL VASCULAR, (B)(4)), AND BEGRAFT (BENTLEY INNOMED, (B)(4)). IN TOTAL 29 PATIENTS WERE IMPLANTED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE PRIMARY OUTCOME WAS PROCEDURE-RELATED REINTERVENTIONS FOR OCCLUSION OR HIGH-GRADE (>70%) STENOSIS OF THE BRIDGING DEVICE, OCCLUSION OF THE IPSILATERAL COMMON OR EXTERNAL ILIAC ARTERY (EIA), TYPE I ENDOLEAK, RUPTURE, OR INFECTION FOLLOWING IBD IMPLANTATION. AMONG 10 (1.5%) OCCLUDED EIAS IPSILATERAL TO A DEPLOYED IBD WITHIN THE FIRST 30 DAYS AFTER THE IMPLANTATION, 6 UNDERWENT A REINTERVENTION WITH ADDITIONAL STENT PLACEMENT AFTER THROMBOLYSIS (N=4) OR A FEMOROFEMORAL OR ILIOFEMORAL CROSSOVER BYPASS (N=2). THE OTHER 4 OCCLUSIONS WERE TREATED CONSERVATIVELY DUE TO MODERATE CLAUDICATION. BOTH EIA AND COMMON ILIAC ARTERY (CIA) SEGMENTS OCCLUDED IN 30 (4.6%) OF THE 650 IBDS. TWO PATIENTS HAD A CROSSOVER BYPASS (N=1) OR EIA¿COMMON FEMORAL BYPASS (N=1); 14 WERE TREATED BY ENDOVASCULAR MEANS WITH STENT/STENT-GRAFT PLACEMENT AFTER SUCCESSFUL THROMBOLYSIS. IN THE OTHER 14 PATIENTS, NO SPECIFIC TREATMENT WAS PERFORMED DUE TO MODERATE CLAUDICATION (N=3) OR HIGH RISK FOR SURGICAL CONVERSION DUE TO COMORBIDITIES OR PATIENT REFUSAL (N=11). SEVEN (1.2%) IBDS PRESENTING ISOLATED EIA OCCLUSION DURING LATE FOLLOW-UP WERE TREATED. SIX OCCLUSIONS WERE RECANALIZED AND RECEIVED A NITINOL STENT; 1 PATIENT UNDERWENT SURGICAL REPAIR BY DISOBLITERATION AND PATCHPLASTY OF THE COMMON FEMORAL ARTERY AND EIA. A DEFINITE ALLEGATION ON A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS IN RELATION TO THE ABOVE MENTIONED ADVERSE EVENTS WAS NOT STATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669374 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention