BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 1905211 · Received November 22, 2010

    Report

    Report Number
    3004742046-2010-00550
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 3, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. BILIARY STENT USED IN PERIPHERAL ARTERY. EVALUATION SUMMARY: EVALUATION OF THE RETURNED OTW OMNILINK STENT DELIVERY SYSTEM (SDS) FOUND BLOOD ON THE HUB AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH THE BEING ADVANCED INTO THE ANATOMY AND INFLATED AS REPORTED. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AS REPORTED AND WAS NOT RETURNED. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH THE REPORTED INFLATION. THERE WAS NO DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. A NON-ABBOTT INTRODUCER SHEATH WAS RETURNED WITH BLOOD IN AND ON THE INTRODUCER SHEATH. THERE WAS NO DAMAGE NOTED TO THE NON-ABBOTT INTRODUCER SHEATH. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREP, INTERACTION WITH ACCESSORY DEVICES, INTERACTION WITH THE LESION, TORTUOUS ANATOMY, OR HEAVY CALCIFICATIONS. TO ENSURE THIS IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR PROPER STENT PLACEMENT AND STENT DAMAGE, AND ARE 100% DIMENSIONALLY INSPECTED FOR CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, SAMPLES ARE REMOVED FROM EACH LOT FOR DESTRUCTIVE STENT DISLODGEMENT TESTING. IN THIS CASE, THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. BASED ON THE REPORTED INFORMATION, IT IS LIKELY THAT THE STENT DISLODGED DUE TO INTERACTION WITH THE NON-ABBOTT INTRODUCER SHEATH. IT IS POSSIBLE THAT THE VALVE WAS ONLY PARTIALLY OPENED PRIOR TO ADVANCING THE STENT CAUSING THE STENT TO DISLODGE AND REMAIN IN THE BURST VALVE. AS IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SFA, IT SHOULD BE NOTED THAT THE OTW OMNILINK INSTRUCTION FOR USE INDICATES THAT THE OMNILINK IS INDICATED FOR USE IN PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. HOWEVER, IN THIS CASE, THE USE OF THE OMNILINK IN THE SFA DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE DISLODGMENT. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS REPORT. OVERALL, THE REPORTED STENT DISLODGMENT APPEARS TO BE RELATED TO DIFFICULTIES DURING THE PROCEDURE AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE OMNILINK WAS ADVANCED TO THE LESION AND THOUGHT TO BE DEPLOYED; HOWEVER, WHEN THE DEVICE WAS REMOVED, THE STENT WAS FOUND DISLODGED IN THE TUOHY BORST VALVE. A NEW OMNILINK WAS DEPLOYED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THE PATIENT OUTCOME WAS GOOD. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK .035 STENT DELIVERY SYSTEM BILIARY STENT SYSTEM FGE AV-TEMECULA 9111251

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR