BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3183060 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03888
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    January 2, 2013
    Report Date
    May 30, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATED. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS AND RE-STENOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS 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. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT PATIENT DATA WAS OBTAINED FROM 11 COMPLETED RANDOMIZED TRIALS, INCLUDING A TOTAL OF 972 PATIENTS WITH DIABETES, 616 PATIENTS RANDOMIZED TO DRUG ELUTING STENTS (DES) AND 356 PATIENTS RANDOMIZED TO BARE METAL STENTS (BMS). THE DES PATIENTS RECEIVED NON-ABBOTT DRUG ELUTING STENTS AND THE BMS PATIENTS RECEIVED NON-ABBOTT BARE METAL STENTS AND UNSPECIFIED VISION STENTS BETWEEN 2003 AND 2006. CLINICAL OUTCOMES FOR THE BMS PATIENTS WERE AS FOLLOWS: 27 % TARGET VESSEL REVASCULARIZATION (TVR); 8.7 % MYOCARDIAL INFARCTION; 7.1 % STENT THROMBOSIS; 21.6 % DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283472 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S