BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX STRETCH VASCULAR GRAFT

    MDR report key: 3313302 · Received August 21, 2013

    Report

    Report Number
    2017233-2013-00575
    Event Type
    Injury
    Date Received
    August 21, 2013
    Date of Event
    May 11, 2013
    Report Date
    July 22, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K903931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO TESTING METHODS PERFORMED (NO LOT NUMBER REPORTED). THE ARTICLE CONCLUDED, "WE FOUND THAT A CHILD'S ANATOMY HAS AN IMPACT ON THE OCCURRENCE OF POSTOPERATIVE IN-HOSPITAL SHUNT OCCLUSION. THE PRESENCE OF SMALL PULMONARY ARTERIES MAY HEIGHTEN THE INCIDENCE OF POSTOPERATIVE SHUNT OCCLUSION EITHER BECAUSE OF TECHNICAL ISSUES OR BY INCREASING THE RESISTANCE TO BLOOD FLOW THROUGH THE SHUNT." NOTE: TWELVE REPORTED PEDIATRIC SHUNT OCCLUSIONS WERE REPORTED IN THE ARTICLE.

    Description of Event or Problem · 1

    DURING AN ARTICLE REVIEW ("IN-HOSPITAL SHUNT OCCLUSION IN INFANTS UNDERGOING A MODIFIED BLALOCK-TAUSSIG SHUNT." ANNALS OF THORACIC SURGERY 2013; 96:176-82, AUTHORS: NINA A. GUZZETTA, MD, GREGORY S. FOSTER, BS, NAVYATA MRUTHINTI, MPH, PATRICK D. KILGORE, MS, BRUCE E. MILLER, MD, AND KIRK R. KANTER, MD), A RETROSPECTIVE REVIEW BETWEEN MARCH 1, 2005, AND DECEMBER 31 IDENTIFIED 207 PTS WHICH RECEIVED A MODIFIED BLALOCK-TAUSSIG SHUNT. A (B)(6) PT WAS IMPLANTED WITH A 3.5 MM SHUNT. THE SHUNT REPORTEDLY OCCLUDED 60 HRS POST IMPLANT. THE PT TREATMENT INCLUDED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND 1 DAY LATER SURGICAL REVISION IN OPERATING ROOM. THE PHYSICIAN FINDINGS WERE AS FOLLOWS: "ACUTE EPISODE OF DESATURATION UNRESPONSIVE TO TREATMENT; INADEQUATE PROXIMAL ANASTOMOSIS DUE TO DUCTAL TISSUE; SHUNT REPOSITIONED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406626 GORE-TEX STRETCH VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention