BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1961789 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00312
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. GUIDE WIRE: WHISPERES. GUIDE CATH: JL4. STENT: UNSPECIFIED COCR. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD VISIBLE ON THE BALLOON AND CONTRAST IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH HANDLING AND PREPARATION. THE STENT WAS DISLODGED FROM THE BALLOON AND NOT RETURNED, CONFIRMING THE REPORTED INFORMATION. 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. THE INNER MEMBER WAS WRINKLED 6.8 CM AND 7.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE WRINKLED SHAFT MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, IT IS LIKELY THAT INTERACTION WITH THE MODERATELY TORTUOUS AND CALCIFIED LESION CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE AND LOOSENED THE STENT ON THE BALLOON. SUBSEQUENT INTERACTION WITH THE CALCIFIED AND TORTUOUS ANATOMY DURING RETRACTION WOULD HAVE THEN LED TO THE STENT DISLODGEMENT. TO ENSURE THE REPORTED DIFFICULTIES ARE NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS 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. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID CIRCUMFLEX, WHICH WAS TORTUOUS AND CALCIFIED. THE 3.5 X 18 MM WAS UNABLE TO CROSS AND THE STENT DISLODGED IN THE VESSEL. THE DELIVERY SYSTEM WAS REMOVED AND A SNARE DEVICE WAS USED TO RETRIEVE THE STENT FROM THE PATIENT. ANOTHER ATTEMPT WAS MADE TO CROSS WITH A NON-ABBOTT STENT, BUT IT WAS ALSO UNSUCCESSFUL. THE PATIENT WAS RECOMMENDED FOR CORONARY BYPASS SURGERY. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 9031141

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention