BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 10489215 · Received September 3, 2020

    Report

    Report Number
    2017233-2020-01210
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 13, 2020
    Report Date
    April 27, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Description of Event or Problem · 1

    JOURNAL PRE-PROOF -ENDOSCOPIC INCISIONAL THERAPY AND OTHER NOVEL STRATEGIES FOR EFFECTIVE TREATMENT OF CONGENITAL ESOPHAGEAL STENOSIS¿; JESSICA YASUDA, M.D.; STEVEN STAFFA, M.D.; SUSANNAH CLARK, M.D.; PETER NGO, M.D.; BENJAMIN ZENDEJAS, M.D.; THOMAS HAMILTON, M.D.;RUSSELL JENNINGS, M.D.; MICHAEL MANFREDI, M.D.; JOURNAL OF PEDIATRIC SURGERY;ACCEPTED DATE: 4 JANUARY 2020; DOI:HTTPS://DOI.ORG/10.1016/J.JPEDSURG.2020.01.013. THE PURPOSE OF THE STUDY WAS THAT THE DOCTORS HYPOTHESIZED THAT NOVEL METHODS OF ENDOSCOPIC CONGENITAL ESOPHAGEAL STENOSIS (CES) MANAGEMENT INCLUDING ENDOSCOPIC INCISIONAL THERAPY (EIT) WOULD LEAD TO LESS SURGICAL INTERVENTION. THIS ARTICLE IS A RETROSPECTIVELY REVIEWED THE MEDICAL RECORDS OF ALL PATIENTS WITH CES TREATED BY OUR TERTIARY CARE CENTER WHO HAD AT LEAST ONE ENDOSCOPY BETWEEN JULY 2007 AND JULY 2019. THERE ARE 4 (VIABAHN HEPARIN COATED ENDOPROSTHESIS) STENT MIGRATIONS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956005 GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1