BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTRANT INTRODUCER SHEATH

    MDR report key: 10078580 · Received May 21, 2020

    Report

    Report Number
    9612164-2020-01936
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    September 11, 2019
    Report Date
    May 21, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K123990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; INCIDENCE AND PREDICTORS OF VASCULAR COMPLICATIONS IN TRANSAXILLARY TAVI. EUROINTERVENTION (FRANCE), VOLUME:15,ISSUE:15, E1325-E1331 : FEB 2020 DOI: 10.4244/EIJ-D-19-00588 VAN DER WULP, KEES; THIJS, INA; VAN WELY, MARLEEN; LOVERBOS, ANTON; GEHLMANN, HELMUT; VERKROOST, MICHEL; VAN GARSSE, LEEN; KIEVIT, P ETER; VART, PRIYA; EL MESSAOUDI, SALOUA; BOSBOOM, DENNIS; MORSHUIS, WIM; VAN ROYEN, NIELS. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SENTRANT SHEATHS WERE USED AS AN ACCESSORY DEVICES IN TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURES. THE FOLLOWING SERIOUS INJURIES WERE OBSERVED: DISSECTION, STENOSIS, PERFORATION, SURGICAL INTERVENTION, THROMBOSIS. DEATH EVENTS WERE ALSO REPORTED HOWEVER THERE IS NO CAUSAL LINK THAT SENTRANT SHEATH MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544439 SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER DYB MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention