BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 10354079 · Received August 1, 2020

    Report

    Report Number
    2017233-2020-01070
    Event Type
    Injury
    Date Received
    August 1, 2020
    Date of Event
    November 10, 2019
    Report Date
    August 26, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RECEIVED FEEDBACK FROM THE GORE FIELD SALES ASSOCIATE THAT NO FURTHER INFORMATION IS AVAILABLE, THE CASE/COMPLAINT WILL BE CLOSED WITH INFORMATION PROVIDED IN THE ARTICLE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL NUMBER REMAINS UNKNOWN. THE DEVICE IS UNAVAILABLE, SO NO ENGINEERING EVALUATION CAN BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATED ARTICLE IS CITED AS: NI Q, YANG S, XUE G, ZHOU Z, ZHANG L, YE M, VIABAHN STENT GRAFT FOR THE ENDOVASCULAR TREATMENT OF OCCLUSIVE LESIONS IN THE FEMOROPOPLITEAL ARTERY: A RETROSPECTIVE COHORT STUDY WITH FOUR-YEAR FOLLOW-UP, ANNALS OF VASCULAR SURGERY (2019), DOI: HTTPS://DOI.ORG/10.1016/ J.AVSG.2019.11.018. PROVIDED MEAN AGE AND GENDER OF ARTICLE WERE USED TO COMPLETE PATIENT INFORMATION. COMPLAINT NUMBER WAS USED FOR PATIENT IDENTIFIER. FURTHER INVESTIGATION IS BEING CONDUCTED AND THE INFORMATION WILL BE INCLUDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    WITHIN THE ARTICLE ¿VIABAHN STENT GRAFT FOR THE ENDOVASCULAR TREATMENT OF OCCLUSIVE LESIONS IN THE FEMOROPOPLITEAL ARTERY: A RETROSPECTIVE COHORT STUDY WITH FOUR-YEAR FOLLOW-UP¿, PUBLISHED BY MENG YE ET AL, WITHIN THE JOURNAL ANNALS OF VASCULAR SURGERY, THE ARTICLE INDICATES THE FOLLOWING: THE AIM OF THE STUDY WAS TO EVALUATE THE LONG-TERM PATENCY OF THE GORE® VIABAHN® ENDOPROSTHESES IN PATIENTS WITH OCCLUSIVE LESIONS IN THE FEMOROPOPLITEAL ARTERY. A TOTAL OF 66 PATIENTS, WHO HAD BEEN TREATED WITH THE GORE® VIABAHN® ENDOPROSTHESES DURING THE PERIOD FROM JUNE 2013 TO DECEMBER 2016, WERE RETROSPECTIVELY INCLUDED. IN ALL CASES ACCESS TO THE ARTERY WAS ACHIEVED FROM THE CONTRALATERAL FEMORAL ARTERY BY A CROSSOVER APPROACH. AFTER PRE-DILATION WITH A 3¿4-MM BALLOON, THE GORE® VIABAHN® ENDOPROSTHESES WERE DEPLOYED PERCUTANEOUSLY THROUGH 7 FR SHEATHS. POST-DILATION WAS PERFORMED IN ALL PATIENTS. 61 PATIENTS WERE FOLLOWED FOR A MEAN DURATION OF 29.5 MONTHS. THE FOLLOW-UP¿S TOOK PLACE AFTER 1-YEAR, 2-YEARS, 3-YEARS, AND 4-YEARS. TWO PATIENTS HAD PERIOPERATIVE COMPLICATIONS, INCLUDING TWO WITH DISTAL EMBOLISM WHICH WAS TREATED BY CATHETER-DIRECTED THROMBOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818278 GORE VIABAHN ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention