BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 4642496 · Received March 30, 2015

    Report

    Report Number
    2024168-2015-01705
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Date of Event
    March 8, 2015
    Report Date
    March 9, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL SUPERA STENTS REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF JOB TRAVELER REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE HISTORICAL DATA REVIEW AND QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE FIRST SUPERA (SE-05-060-120-6F, LOT # 02365058) DEPLOYED SEEMED TO SEESAW INSIDE THE VESSEL AS THE THUMB SLIDER WAS MOVED BACK DURING DEPLOYMENT. THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, SLIPPED UPWARD IN THE VESSEL AND REQUIRED US TO OPEN A SECOND STENT. THE SECOND STENT (SE-05-040-120-6F, LOT # 02371057) SEEMED TO WANT TO STACK ON ITSELF NO MATTER WHAT WAS DONE. WHEN THE STENT APPEARED TO BE DEPLOYED, IT WAS RELEASED FROM THE SYSTEM. DURING THE ATTEMPT TO REMOVE THE DELIVERY CATHETER THE STENT APPEARED TO MOVE BACK, AND WHEN THE CATHETER CAME OUT, THE STENT WAS STILL ATTACHED TO IT AT THE NOSE CONE. A THIRD STENT WAS OPENED FOR USE. THIS THIRD STENT (SE-05-040-120-6F, LOT # 02371057) SEEMED TO DETACH FROM THE NOSE CONE PROPERLY AND IT WAS FELT THAT IT HAD DEPLOYED AS NORMAL UNTIL AN ATTEMPT WAS MADE TO REMOVE THE DELIVERY CATHETER. THE ENTIRE STENT WAS PULLED BACK INTO THE PROXIMAL SFA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207856 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 02371057

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: SUPERA