BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 3140991 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03439
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. IT SHOULD BE NOTED THE REPORTED DISSECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MODERATELY TORTUOUS PROXIMAL CIRCUMFLEX ARTERY FOR TREATMENT OF A 78% DE NOVO LESION, PRE-DILATATION WAS PERFORMED AND A 2.5X12 RX MINI VISION STENT WAS DEPLOYED. AFTER DEPLOYMENT OF THE STENT, A DISSECTION WAS NOTED. A 2.25X12 MINI VISION STENT WAS DEPLOYED OVERLAPPING THE FIRST STENT FOR TREATMENT OF THE DISSECTION. TIMI III BLOOD FLOW WAS MAINTAINED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244180 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 1072641

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention