BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2549405 · Received April 26, 2012

    Report

    Report Number
    2024168-2012-02669
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 4, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT SEPARATION WAS ABLE TO BE CONFIRMED. THE DIFFICULTY DEPLOYING THE STENT AND DIFFICULTY REMOVING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED THE ABSOLUTE PRO .035 PERIPHERAL SELF EXPANDING STENT SYSTEM INSTRUCTIONS FOR USE STATES: DO NOT ATTEMPT TO PULL A PARTIALLY EXPANDED STENT BACK THROUGH THE INTRODUCER SHEATH OR GUIDING CATHETER. THE STENT IS NOT DESIGNED FOR RECAPTURING. ONCE THE STENT HAS STARTED TO DEPLOY, IT IS NOT RECOMMENDED TO REMOVE THE STENT WITH THE DELIVERY SYSTEM. THE STENT IS NOT DESIGNED FOR REPOSITIONING ONCE THE STENT HAS APPOSED TO THE VESSEL OR DUCT WALL.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE (B)(4): INCORRECT REMOVAL. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS A CROSS OVER PROCEDURE TO TREAT A HEAVY CALCIFIED AND MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED THROUGH A NON-ABBOTT 6F SHEATH. THE SESS WAS POSITIONED IN THE TARGET LESION AND AN ATTEMPT WAS MADE TO DEPLOY THE STENT IMPLANT. WHEN THE SHEATH WAS RETRACTED APPROXIMATELY 50% THE THUMBWHEEL STOPPED TURNING AND THE STENT IMPLANT COULD NOT BE FULLY DEPLOYED. THE DECISION WAS MADE TO RETRACT THE SESS BACK INTO THE 6F SHEATH. THERE WAS RESISTANCE, BUT HE WAS ABLE TO RETRACT THE STENT IMPLANT INTO THE 6F SHEATH AND THEY WERE REMOVED AS ONE UNIT. OUTSIDE THE ANATOMY, THE STENT IMPLANT WAS DISLODGED FROM THE CATHETER AND HAD SEPARATED INTO TWO PIECES WITH THE PROXIMAL PORTION LOCATED IN THE 6F SHEATH. THE DISTAL PORTION WAS FOUND DEPLOYED INSIDE THE TARGET LESION AND WAS STRETCHED TO A LENGTH THAT COVERED THE LESION, THEREFORE, THE PHYSICIAN DECIDED TO LEAVE THE VESSEL AS IS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 1030261

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: 6F CROSSOVER