BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM

    MDR report key: 3930410 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04482
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS, PREDILATATION DIAMETER. 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 COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS REPORTED FROM THIS LOT. PER THE SUPERA INSTRUCTION FOR USE (IFU) THE RECOMMENDED PRE-DILATATION DIAMETER FOR A 6.5 MM STENT IS GREATER THAN 6.5 MM BALLOON. THE IFU ALSO STATES: THE POST-DILATED VESSEL SHOULD BE AT LEAST THE SIZE OF THE STENT DIAMETER. IF RECOMMENDED VESSEL DIAMETER CANNOT BE GAINED, OPTIMAL STENT DEPLOYMENT MAY NOT BE ACHIEVED AND REVISED STENT SIZING SHOULD BE CONSIDERED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, NON-TORTUOUS, SUPERFICIAL FEMORAL ARTERY (SFA). AFTER 6.0 TO NOMINAL VESSEL PREDILATATION, ONCE THE 6.5 X 80 CM SUPERA STENT WAS ADVANCED AND DEPLOYED WITHOUT NOTED ISSUE, THE PHYSICIAN NOTED THE STENT ELONGATED TO ABOUT 120 CM WHEN DEPLOYED. THERE WAS NO INTERVENTION PERFORMED; THERE WAS NO RESISTANCE NOTED DURING DEPLOYMENT OR DURING REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 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
    406724 SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 02146067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other