BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 4241338 · Received November 10, 2014

    Report

    Report Number
    2024168-2014-07307
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. 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 THE JOB TRAVELER REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE HISTORICAL DATA REVIEW FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. PER THE SUPERA INSTRUCTIONS FOR USE (IFU), THE RECOMMENDED PRE-DILATATION DIAMETER FOR A 5.5 MM STENT IS GREATER THAN 5.5 MM BALLOON. PRECAUTION: 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: 6F MEDTRONIC MULTI-PURPOSE CATHETER. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES. A 5.0 X 250 MM NON-ABBOTT BALLOON CATHETER WAS INFLATED TO 12 ATMOSPHERES FOR 1 MINUTE FOR PRE-DILATATION. A 5.5 X 100 MM SUPERA WAS ADVANCED TO THE LESION; HOWEVER, WHEN ATTEMPTING TO DEPLOY, THE STENT ELONGATED OVER 50% INSIDE THE ACCESS SHEATH. THE DELIVERY SHEATH WAS PULLED BACK AND THE TIP SEPARATED. THE SHEATH COULD NOT BE PULLED BACK BECAUSE THE STENT HAD ELONGATED SO MUCH AND THE STENT WOULD HAVE BEEN PULLED PARTIALLY OUT OF THE ANATOMY, SO A 6F MULTI-PURPOSE CATHETER WAS USED TO PUSH THE STENT OUT OF THE SHEATH AND IT WAS DEPLOYED IN THE LESION AND PARTIALLY IN HEALTHY TISSUE. THE TIP WAS THEN REMOVED USING A GOOSENECK SNARE DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723703 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 02305060

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention CONCOMITANT MEDICAL DEVICES