BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM

    MDR report key: 4240829 · Received November 10, 2014

    Report

    Report Number
    2024168-2014-07304
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FROM THIS LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT WAS REPORTED THAT THE STENT REMAINS IN THE ANATOMY AND THE STENT DELIVERY SYSTEM WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPERA STENT STACKED A LITTLE BIT DURING DEPLOYMENT IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED AND ULCERATED TARGET LESION IN THE RIGHT PROXIMAL POPLITEAL ARTERY, LEAVING APPROXIMATELY 8 MM OF THE PROXIMAL LESION UNSTENTED. REPORTEDLY, THERE WERE SECTIONS IN THE LESION WHERE THE ULCERATION CAUSED THE STENT TO STACK OR SHORTEN. THE VESSEL DIAMETER WAS 5.0 AND THE VESSEL HAD BEEN PREDILATED WITH A 6.0 BALLOON DILATATION CATHETER AT 10 ATMOSPHERES FOR 90 SECONDS. THE DIAMETER OF THE BALLOON REACHED 6.3, WHICH OVER-PREPARED THE TARGET LESION. A SECOND SUPERA STENT WAS IMPLANTED TO COVER THE FIRST 8 MM OF THE LESION. THIS WAS THE PHYSICIAN'S FIRST USE OF A SUPERA STENT IN THE PERIPHERAL VASCULATURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722672 SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 02246057

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention