BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3051148 · Received April 10, 2013

    Report

    Report Number
    2024168-2013-02181
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    September 12, 2012
    Report Date
    March 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, MYOCARDIAL INFARCTION AND RESTENOSIS ARE LISTED IN THE VISION INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, 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. THE ADDITIONAL RX VISION, REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION (MI) WITH 95% STENOSED LEFT ANTERIOR DESCENDING ARTERY (LAD) AND TWO MULTI-LINK VISION STENTS WERE IMPLANTED IN A LAD. APPROXIMATELY FIVE MONTHS LATER, ON (B)(6) 2012, THE PATIENT EXPERIENCED CHEST PAINS AND WAS DIAGNOSED WITH ANOTHER MI. AN ANGIOGRAM WAS DONE WITH FINDINGS OF 99% RE-STENOSIS IN BOTH OF THE VISION STENTS IMPLANTED IN THE LAD. A CORONARY ARTERY BYPASS WAS DONE OF THE LAD AND THE SYMPTOMS RESOLVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152476 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2012341

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R| S VISION 3.5 X 28 MM STENT