BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2024184 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01832
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE DISTAL SHAFT, CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND NOT RETURNED. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THERE WAS A BEND IN THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BEND MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE STENT DELIVERY SYSTEM (SDS), NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. TO ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. RETURN OF THE DISLODGED STENT AND PROTECTIVE SHEATH MAY HAVE AIDED IN THE INVESTIGATION. IT IS POSSIBLE THE PROTECTIVE SHEATH WAS INADVERTENTLY HANDLED DURING REMOVAL, RESULTING IN THE STENT DISLODGING. ANALYSIS NOTED BALLOON PEELING ON THE DISTAL TAPER WHICH WAS NOT INITIALLY REPORTED WITH THE INCIDENT INFORMATION. THE BALLOON PEELING APPEARS TO BE THE RESULT OF HANDLING, AS THERE WAS NO REPORT OF ANY DAMAGE TO THE BALLOON DURING VISUAL INSPECTION OR PREPARATION OF THE PRODUCT PRIOR TO THE PROCEDURE. TO HELP ENSURE THAT THE BALLOON SHREDDING IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE VISUALLY INSPECTED FOR BALLOON SHREDDING. IT IS POSSIBLE THAT THE BALLOON MAY HAVE BEEN INADVERTENTLY HANDLED, WHICH MAY HAVE CONTRIBUTED TO THE SHREDDING OF THE BALLOON MATERIAL. A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    REPORTEDLY THE STENT DISLODGED DURING PREP WHEN THE STYLET AND SHEATH WERE BEING REMOVED, HOWEVER, IT WAS NOT NOTICED UNTIL THE STENT DELIVERY SYSTEM (SDS) WAS ABOUT TO BE LOADED ONTO THE GUIDE WIRE. THE DEVICE WAS NOT USED ON THE PATIENT. THE STENT AND STYLET HAVE BEEN DISCARDED, HOWEVER, THE SDS WILL BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 1012241

    Patients

    Seq Age Sex Outcome Treatment
    1