BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO MEDICAL CORPORATION

    MDR report key: 6497686 · Received April 17, 2017

    Report

    Report Number
    6497686
    Event Type
    Injury
    Date Received
    April 17, 2017
    Date of Event
    March 12, 2017
    Report Date
    April 12, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ELECTIVE TREATMENT OF MAY-THURNER SYNDROME; PROCEDURE ON (B)(6) 2017 IN IR; 4 COILS WERE PLACED TO THE LEFT INTERNAL ILIAC VEIN. VENOGRAM REVEALED REFLUX OF 4 BRANCHES WHICH WERE GELFORMED AND EMBOLIZED WITH AZUR COILS. PT EXPERIENCED AND COMPLAINED OF CHEST PAIN AND SHORTNESS OF BREATH; SO PRESENTED TO ER ON (B)(6) 2017. CT SCAN OF CHEST REVEALED AN ENDOVASCULAR IN THE RIGHT MIDDLE LOBE PULMONARY ARTERY WHICH APPEARS TO RESIDE IN THE TERTIARY BRANCH; NO INTERVENTION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280333 TERUMO MEDICAL CORPORATION ENDOVASCULAR STENT - AZUR KRD TERUMO MEDICAL CORPORATION AZUR 350 8 X 20 COIL 16062112
    280334 TERUMO MEDICAL CORPORATION ENDOVASCULAR STENT - AZUR KRD TERUMO MEDICAL CORPORATION AZUR CX 18.5MM X 16 CM COIL 150507L4

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R