BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM

    MDR report key: 3953013 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04712
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT SHEATH WAS NOT TORN, THEREFORE, THE REPORTED TEAR WAS NOT CONFIRMED. HOWEVER, THE STENT IMPLANT WAS PARTIALLY EXPANDED DISTAL TO THE DISTAL END OF THE STENT SHEATH AND THE STENT IMPLANT WAS TANGLED DISTAL TO THE DISTAL END OF THE SHEATH. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6 MM BALLOON WAS USED FOR PREDILATATION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO RESISTANCE DURING ADVANCEMENT TO THE SFA WITH THE SUPERA STENT DELIVERY SYSTEM (SDS). THE SFA WAS ESTIMATED TO BE 5 MM IN DIAMETER. THE DEPLOYMENT SHEATH PARTIALLY TORE WHEN DEPLOYING THE SUPERA STENT. THERE WAS NO DIFFICULTY WITH THE THUMB ADVANCER. APPROXIMATELY 1/4 OF THE STENT DEPLOYED WHEN THE SHEATH ISSUE WAS NOTICED ON FLUOROSCOPY. THE SDS, WITH THE PARTIALLY DEPLOYED STENT, WAS REMOVED FROM THE ANATOMY WITHOUT RESISTANCE. THERE WAS NOTHING LEFT IN ANATOMY. THIS PHYSICIAN IS TRAINED ON THE SUPERA STENT AND IS A HIGH VOLUME USER. ANOTHER SUPERA STENT WAS IMPLANTED WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430358 SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 02223060

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR