BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3183055 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03886
    Event Type
    Death
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DEATH IS LISTED IN THE VISION 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. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED IN B5 ARE 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 STENT 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
    283802 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death