BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 14989106 · Received July 12, 2022

    Report

    Report Number
    2247858-2022-00104
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 14, 2022
    Report Date
    November 28, 2022
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A TREO ABDOMINAL STENT-GRAFT CUSTOM-MADE DEVICE. THE CUSTOM MADE TREO DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE TREO ABDOMINAL STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN THE NETHERLANDS.

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A TREO ABDOMINAL STENT-GRAFT CUSTOM-MADE DEVICE. THE CUSTOM MADE TREO DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE TREO ABDOMINAL STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN THE NETHERLANDS.

    Description of Event or Problem · 0

    HOLE IN SHEATH WHICH CAUSED STENT PROTRUDING THE SHEATH A BIT WHICH GAVE A LOT OF FRICTION WHEN RELEASING THE STENT. THIS EXTENSIVE AMOUNT OF FRICTION BROKE THE SHEATH RELEASE LEVER AND DEPLOYMENT WAS NOT POSSIBLE. PATIENT OUTCOME: "UNTREATED RIGHT ILIAC COMMON ARTERY ANEURYSM, NO ADDITIONAL INJURIES INFLICTED DUE TO FAILED DEPLOYMENT."

    Description of Event or Problem · 0

    HOLE IN SHEATH WHICH CAUSED STENT PROTRUDING THE SHEATH A BIT WHICH GAVE A LOT OF FRICTION WHEN RELEASING THE STENT. THIS EXTENSIVE AMOUNT OF FRICTION BROKE THE SHEATH RELEASE LEVER AND DEPLOYMENT WAS NOT POSSIBLE. PATIENT OUTCOME - "UNTREATED RIGHT ILIAC COMMON ARTERY ANEURYSM, NO ADDITIONAL INJURIES INFLICTED DUE TO FAILED DEPLOYMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652729 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2205260076

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male