BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2160052 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04941
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE BALLOON AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE STENT DELIVERY SYSTEM (SDS) BEING ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS DISLODGED AND WAS NOT RETURNED, CONFIRMING THE REPORTED DISLODGEMENT. 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 17 CM DISTAL TO THE STRAIN RELIEF TUBING. 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. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE OR STENT DISLODGEMENT. 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 HEAVILY 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 LESION DURING MANIPULATION WITHIN THE LESION WOULD HAVE THEN LED TO THE STENT DISLODGEMENT. ADDITIONAL THERAPY WAS USED IN THE ATTEMPTS TO SNARE THE DISLODGED STENT, HOWEVER THIS WAS UNSUCCESSFUL AND THE DISLODGED STENT REMAINS IN THE PATIENT ANATOMY. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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 DURING A PROCEDURE TO TREAT A HEAVILY CALCIFIED, PROXIMAL CORONARY LEFT MAIN LESION, THE RX VISION 3.5 X 12 MM STENT DISLODGED. A MINI TREK 2.0 X 12 MM WAS USED IN AN ATTEMPT TO SNARE THE DISLODGED STENT, BUT WAS UNSUCCESSFUL. A NON-ABBOTT 3.0 X 15 MM STENT FAILED TO CROSS TO TREAT THE LESION. ANOTHER NON-ABBOTT 3.0 X 16 MM WAS ABLE TO CROSS TO THE LESION. THERE WERE NO ADVERSE PATIENT SEQUELAE REPORTED. 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 0030842

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention