BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2834525 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07232
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT DELIVERY SYSTEM REMOVAL WAS ATTEMPTED AGAINST RESISTANCE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT CORONARY ARTERY STENTING PROCEDURE AFTER PRE-DILATING THE DISTAL VESSEL, THE 3.5X15MM VISION STENT DELIVERY SYSTEM FAILED TO CROSS THE HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION. UPON REMOVAL AND AGAINST RESISTANCE, THE STENT DISLODGED WHEN ATTEMPTING TO PULL THE SYSTEM INTO THE GUIDE CATHETER. SMALL BALLOON DILATATION CATHETERS WERE ADVANCED INTO THE STENT AND PROGRESSIVELY EXPANDED THE STENT INTO THE PROXIMAL LESION UNTIL THE STENT WAS WELL APPOSED TO THE VESSEL, PARTIALLY COVERING THE LESION. THE REST OF THE LESION WAS SUCCESSFULLY STENTED WITH ANOTHER VISION STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION 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 2071841

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention