BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM

    MDR report key: 3943816 · Received July 18, 2014

    Report

    Report Number
    2024168-2014-04623
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 OTHER INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID SUPERFICIAL FEMORAL ARTERY USING A CROSSOVER ACCESS. DURING STENT DEPLOYMENT, THE DISTAL TIP OF THE CATHETER CAUGHT THE STENT. THE SYSTEM WAS PULLED BACK AND THE DISTAL CATHETER TIP PULLED ON THE STENT, WHICH WAS EXTENDED OVER THE LENGTH OF THE LESION (THE PROXIMAL END COMING INTO THE LEFT FEMORAL ARTERY). THE DISTAL CATHETER TIP WAS ABLE TO BE REMOVED FROM THE PATIENT. THE STENT IS LEFT IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, NEW INFORMATION RECEIVED STATES THAT THE STENT ELONGATED DURING THE CROSS-OVER AND WAS RELEASED. THE SEPARATED DISTAL TIP OF THE CATHETER WAS ABLE TO BE REMOVED SUCCESSFULLY, VIA SNARE AT THE PUNCTURE SITE. THE PATIENT FINAL OUTCOME IS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421707 SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 02343073

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention