BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 10021046 · Received May 4, 2020

    Report

    Report Number
    2134265-2020-05934
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 27, 2020
    Report Date
    June 25, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    PMA / PMN Number
    P180011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (E1) INITIAL REPORTER CITY: ISE CITY MIE PREFECTURE 5160008 DEVICE EVALUATED BY MFR:RETURNED PRODUCT CONSISTED OF AN ELUVIA SELF-EXPANDING STENT SYSTEM WITH A 0.014" GUIDEWIRE STUCK IN THE DEVICE. THE OUTER SHEATH, TIP, INNER SHEATH AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. VISUAL EXAMINATION REVEALED A KINK TO THE OUTER SHEATH AT THE NOSECONE. THE PROXIMAL INNER WAS PROLAPSED INSIDE THE HANDLE. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. INSPECTION OF THE REMAINDER OF THE DEVICE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7X120, 130 CM ELUVIA DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DELIVERY SYSTEM WAS WITHDRAWN AFTER STENT PLACEMENT, THE GUIDEWIRE LOCKED UP IN THE SHAFT. THE DEVICE WAS REMOVED TOGETHER WITH THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7X120, 130 CM ELUVIA DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DELIVERY SYSTEM WAS WITHDRAWN AFTER STENT PLACEMENT, THE GUIDEWIRE LOCKED UP IN THE SHAFT. THE DEVICE WAS REMOVED TOGETHER WITH THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484467 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0024502793

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: VASALLO| GUIDEWIRE: VASALLO| INTRODUCER SHEATH: PARENT6F| INTRODUCER SHEATH: PARENT6F