BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX VASCULAR GRAFT (LINED)

    MDR report key: 9955545 · Received April 13, 2020

    Report

    Report Number
    2017233-2020-00247
    Event Type
    Injury
    Date Received
    April 13, 2020
    Date of Event
    August 1, 2019
    Report Date
    March 20, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO FURTHER INVESTIGATION IS POSSIBLE. REFERENCE MEDWATCH #2017233-2020-00244, #2017233-2020-00245, AND #2017233-2020-00246 FOR ADDITIONAL INDIVIDUAL PATIENT EVENTS WITHIN THE ARTICLE.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: 'LEFT VENTRICULAR ASSIST DEVICE OUTFLOW GRAFT OBSTRUCTION - A COMPLICATION SPECIFIC TO POLYTETRAFLUOROETHYLENE COVERING. A WORD OF CAUTION!' TALAL ALNABELSI, M.D.; ALEXIS SHAFII, M.D.; JOHN GURLEY, M.D.; KENNETH DULNUAN, M.D.; DWIGHT HARRIS, M.D.; MAYA GUGLIN, M.D.; AMERICAN SOCIETY FOR ARTIFICIAL INTERNAL ORGANS (ASAIO) JOURNAL: AUGUST 2019-VOLUME 65 - ISSUE 6 - P E58-E62; DOI: 10.1097/MAT.0000000000000929. THE ARTICLE DISCUSSES THE EVOLUTION OF LEFT VENTRICULAR ASSIST DEVICES (LVADS) AND HOW THEY HAVE CHANGED THE MANAGEMENT OF END-STAGE HEART FAILURE AND THE PRACTICE OF HEART TRANSPLANTATION. THE ARTICLE REPORTS THAT POLYTETRAFLUOROETHYLENE (PTFE) GRAFTS HAVE CUSTOMARILY BEEN USED TO COVER THE OUTFLOW GRAFT BY SURGEONS TO REDUCE ADHESIONS AND FACILITATE REENTRY STERNOTOMY AT THE TIME OF HEART TRANSPLANTATION OR LEFT VENTRICULAR ASSIST DEVICE (LVAD) EXCHANGE. THE ARTICLE REPORTS THE PRESENTATION, DIAGNOSIS, AND TREATMENT OF FOUR CASES OF OUTFLOW GRAFT OBSTRUCTION BECAUSE OF FORMATION OF THROMBUS BETWEEN THE OUTFLOW GRAFT AND ITS PROTECTIVE PTFE COVER. THE FEMALE PATIENT PRESENTED WITH END-STAGE NONISCHEMIC CARDIOMYOPATHY WHO UNDERWENT PLACEMENT OF AN HVAD WITH A 20MM PTFE GRAFT COVERING. ON A SCHEDULED FOLLOW-UP VISIT 29 MONTHS AFTER IMPLANTATION, SHE WAS NOTED TO HAVE MULTIPLE EPISODES OF SUBOPTIMAL FLOWS DESPITE OPTIMIZATION OF HER BLOOD PRESSURE AND VOLUME STATUS. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE CHEST REVEALED EVIDENCE OF THROMBUS BETWEEN THE PTFE COVERING AND OUTFLOW GRAFT. THE PATIENT UNDERWENT SUCCESSFUL PERCUTANEOUS STENTING OF THE OUTFLOW GRAFT WITH 7 OVERLAPPING LD MEGA 12X36 STENTS WITH IMPROVEMENT IN LVAD FLOWS. SHE REMAINS ASYMPTOMATIC AND WITH NO RECURRENT COMPLICATIONS AFTER 7 MONTHS OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417273 GORE TEX VASCULAR GRAFT (LINED) PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other