BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 5575607 · Received April 13, 2016

    Report

    Report Number
    2024168-2016-02388
    Event Type
    Injury
    Date Received
    April 13, 2016
    Date of Event
    March 21, 2016
    Report Date
    May 2, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). USER FACILITY MEDWATCH #5061248. EVALUATION SUMMARY: VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE TIP SEPARATION WAS CONFIRMED. THE ELONGATION WAS UNABLE TO BE CONFIRMED AS IT WAS BASED ON CASE CIRCUMSTANCES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED STENT ELONGATION AND TIP DETACHMENT. THE ADDITIONAL THERAPY, SURGERY AND HOSPITALIZATION ARE DUE TO OPERATIONAL CONTEXT. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED NO OTHER INCIDENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SEVERELY DISEASED, MILDLY CALCIFIED, DISTAL SUPERFICIAL FEMORAL ARTERY. A 5.5X150 SUPERA STENT WAS SUCCESSFULLY IMPLANTED. A SECOND 5.5X120 SUPERA SELF-EXPANDING STENT SYSTEM WAS ADVANCED WITHOUT USE OF A SHEATH, AND THERE WAS SOME ELONGATION DURING DEPLOYMENT. THE WHITE RATCHET MECHANISM DETACHED AND WAS CAUGHT IN THE STENT. ALTHOUGH THE STENT DEPLOYMENT WAS ACCEPTABLE, SURGERY WAS PERFORMED AT THE KNEE TO REMOVE THE WHITE RATCHET MECHANISM AND DURING THE SURGERY THE SECOND 5.5X120 SUPERA SELF-EXPANDING STENT WAS REMOVED IN ORDER TO ACCESS THE SEPARATED PIECE. AFTER SURGERY, A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS DOING WELL AND IS EXPECTED TO BE DISCHARGED FROM THE HOSPITAL ONE DAY POST-PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING THE INITIAL MDR, A USER FACILITY MEDWATCH REPORT WAS RECEIVED STATING, "STENT PLACED IN THE RIGHT POPLITEAL ARTERY AND WHEN REMOVING THE SHEATH, THE TIP OF THE SHEATH DISLODGED AND SEPARATED FROM THE BODY OF THE SHEATH, RESULTING IN AN OPEN PROCEDURE TO REMOVE THE TIM FROM THE VESSEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230379 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 5112361

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R