BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM

    MDR report key: 3873205 · Received June 13, 2014

    Report

    Report Number
    2024168-2014-03844
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED DEPLOYMENT DIFFICULTY, INACCURATE DELIVERY AND TIP DETACHMENT WERE CONFIRMED. A REVIEW OF THE 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 COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A BRACHIAL ARTERY ACCESS APPROACH DURING A REVASCULARIZATION OF THE COMMON FEMORAL ARTERY PROCEDURE THE SUPERA STENT DELIVERY SYSTEM (SDS) WAS DELIVERED AND DEPLOYED AT THE RESTENOSED NON-ABBOTT STENT WITHOUT NOTED RESISTANCE OR ISSUE. THE SDS WAS REMOVED FROM THE ANATOMY; ON EXAMINATION IT WAS NOTED THAT THE TIP HAD BECOME DISLODGED AND REMAINED IN THE NON-ABBOTT INTRODUCER SHEATH. ADDITIONALLY, THE STENT IMPLANT HAD ALSO BEEN REMOVED AND WAS STUCK IN THE INTRODUCER SHEATH. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. A SECOND STENT WAS USED TO TREAT THE LESION WITHOUT ISSUE AND WITH A GOOD FINAL OUTCOME. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350888 SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 02206067

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: COOK