BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3891350 · Received June 24, 2014

    Report

    Report Number
    2024168-2014-04029
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    April 25, 2014
    Report Date
    June 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE MULTI-LINK VISION CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT THE PROCEDURE FOR TREATMENT OF THE RIGHT CORONARY ARTERY AFTER SUFFERING CARDIAC ARREST, DURING WHICH A 3.5X23 MM RX VISION STENT WAS DEPLOYED. ONE DAY POST PROCEDURE, DURING THE SAME HOSPITAL STAY, THE PATIENT WAS EXPERIENCING CHEST PAIN. ANGIOGRAPHY REVEALED IN-STENT THROMBOSIS HAD OCCURRED FOR WHICH A BALLOON CATHETER WAS USED FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367751 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 1101241

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R