BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 10023554 · Received May 5, 2020

    Report

    Report Number
    2017233-2020-00313
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    March 21, 2017
    Report Date
    August 5, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B7: ADDED PATIENT PRECONDITIONS OF THE COVERED STENT GROUP. H6-CODE 3221: THE REQUESTS TO THE AUTHOR REMAINED UNANSWERED. THE LOT NUMBERS REMAIN UNKNOWN. WITHOUT ADDITIONAL INFORMATION, GORE WAS UNABLE TO DO FURTHER INVESTIGATION OF THIS EVENT. FOR THIS LITERATURE TWO MEDWATCH REPORTS HAVE BEEN TRANSMITTED: MFR REPORT#: 2017233-2020-00312 (GORE#: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: C1. NAME (#1) - CBAS® HEPARIN SURFACE; - MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. - LOT #UNKNOWN. - CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: "EDITOR¿S CHOICE E OUTCOMES OF SELF EXPANDING PTFE COVERED STENT VERSUS BARE METAL STENT FOR CHRONIC ILIAC ARTERY OCCLUSION IN MATCHED COHORTS USING PROPENSITY SCORE MODELLING¿ MICHELE PIAZZA ET AL. EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, EUR J VASC ENDOVASC SURG (2017) 54, 177-185 RECEIVED 17 NOVEMBER 2016, ACCEPTED 21 MARCH 2017, AVAILABLE ONLINE 6 MAY 2017 HTTP://DX.DOI.ORG/10.1016/J.EJVS.2017.03.019. PATIENT AGE: MEAN AGE 68 YEARS. PATIENT GENDER: VAST MAJORITY IS MALE. DATE THE EVENTS OCCURRED ARE UNKNOWN, SO THE DATE THE ARTICLE WAS ACCEPTED WAS USED AS DATE OF EVENT. (B)(4). ADDITONAL INFORMATION WAS REQUESTED FROM THE AUTHOR, LIKE PATIENT INFORMATION, LOT NUMBERS OR DATE OF EVENTS AND ADDITIONAL SURGERIES. THE DEVICES REMAIN IMPLANTED, SO AN ENGINEERING EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: "EDITOR¿S CHOICE E OUTCOMES OF SELF EXPANDING PTFE COVERED STENT VERSUS BARE METAL STENT FOR CHRONIC ILIAC ARTERY OCCLUSION IN MATCHED COHORTS USING PROPENSITY SCORE MODELLING" MICHELE PIAZZA ET AL. EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, EUR J VASC ENDOVASC SURG (2017) 54, 177-185. RECEIVED 17 NOVEMBER 2016, ACCEPTED 21 MARCH 2017, AVAILABLE ONLINE 6 MAY 2017 HTTP://DX.DOI.ORG/10.1016/J.EJVS.2017.03.019 THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE OUTCOMES OF SELF-EXPANDING PTFE COVERED STENTS (CS) WITH BARE METAL STENTS (BMS) IN THE TREATMENT OF CHRONIC ILIAC ARTERY OCCLUSIONS (IAOS) OF THE COMMON ILIAC ARTERY (CIA), THE EXTERNAL ILIAC ARTERY (EIA), OR BOTH. BETWEEN JANUARY 2009 AND DECEMBER 2015, IN TOTAL 107 PATIENTS WERE TREATED. PATIENTS WERE SELECTED FOR REVASCULARISATION FOR PERSISTENT SEVERE CLAUDICATION (< 100 M) AFTER MEDICAL AND PHYSICAL REHABILITATION, THE PRESENCE OF DISABLING CLAUDICATION (< 30 M), AND CRITICAL LIMB ISCHAEMIA. PERI- AND EARLY POST-OPERATIVE (WITHIN 30 DAYS OF SURGERY) MEDICAL AND SURGICAL OUTCOMES AND PRIMARY PATENCY AT 36 MONTHS AFTER SURGERY WERE PRESENTED. ACCESS WAS GAINED BY A GROIN CUTDOWN OR THROUGH A PERCUTANEOUS IPSILATERAL FEMORAL ARTERY, CONTRALATERAL CFA OR LEFT BRACHIAL ARTERY ACCESS. IAO RECANALISATION WAS PERFORMED WITH INTRALUMINAL OR SUBINTIMAL PASSAGE OF A HYDROPHILIC WIRE AND CATHETER. PREDILATATION WAS PERFORMED WITH 4-7 MM DIAMETER NON-COMPLIANT BALLOONS. CFA ENDARTERECTOMY AND PATCH ANGIOPLASTY WERE INCLUDED WITH ILIAC STENTING IN CASES OF CONCOMITANT CFA STENOSIS. FOR BILATERAL CIA OR AORTIC BIFURCATION INTERVENTION, A ¿KISSING BALLOON¿ TECHNIQUE WAS PERFORMED. CS GROUP: IN TOTAL 78 CS WERE IMPLANTED, THEREOF 47 GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (60%). A CS WAS PREFERRED FOR SHORT LESIONS, WHEN THERE WAS A HIGH RISK OF ARTERIAL RUPTURE DURING BALLOONING. A CS WAS PREFERRED FOR LONG LESIONS, IF THERE WAS EVIDENCE OF DIFFUSE CALCIFICATION OF THE ENTIRE AXIS WITH CONCOMITANT SEVERE STENOSIS/OCCLUSION OF THE IPSILATERAL HYPOGASTRIC. A CS WAS PREFERRED FOR LONG LESIONS UNDERGOING SUBINTIMAL RECANALISATION. OF 51 LIMBS WITH LONG LESIONS INVOLVING BOTH THE CIA AND EIA, A SINGLE LONG CS (8 CM, N = 3; 10 CM, N = 9; 15 CM, N = 8) WAS USED TO TREAT THE ENTIRE AXIS IN 20 CASES. THESE CASES PRESENTED CONCOMITANT IPSILATERAL HYPOGASTRIC OCCLUSION/SUB-OCCLUSION. IN THE ARTICLE THE FOLLOWING EARLY POSTOPERATIVE COMPLICATIONS WITHIN 30 DAYS AFTER SURGERY IN THE CS GROUP WERE REPORTED: TWO PATIENTS PRESENTED WITH BUTTOCK CLAUDICATION TREATED WITH CONSERVATIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489772 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization