BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK VISION CORONARY STENT SYSTEM

    MDR report key: 3601055 · Received January 30, 2014

    Report

    Report Number
    2024168-2014-00546
    Event Type
    Death
    Date Received
    January 30, 2014
    Date of Event
    January 8, 2013
    Report Date
    January 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED DEATH AND OCCLUSION ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU), 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 PROMUS REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2010 DURING WHICH A TAXUS LIBERTE STENT WAS DEPLOYED IN THE MID RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2012 THE PATIENT WAS ADMITTED WITH SEVERE CHEST PAIN AND UNDERWENT TARGET VESSEL REVASCULARIZATION WITH PLACEMENT OF A 3.5 X 38 MM PROMUS STENT. ON (B)(6) 2013, 907 DAYS POST INDEX PROCEDURE THE PATIENT WAS ADMITTED WITH CHEST PAIN AND ELECTROCARDIOGRAM (ECG) REVEALED ST ELEVATION MYOCARDIAL INFARCTION AND THROMBOSIS IN THE PROXIMAL RCA WHICH WAS TREATED WITH ASPIRATION THROMBECTOMY, AND PLACEMENT OF A VISION STENT. ON (B)(6) 2013 THE PATIENT HAD MILD CHEST DISCOMFORT AND ANGIOGRAPHY REVEALED OUTFLOW OBSTRUCTION AT THE END OF THE STENTED SEGMENT AND CORONARY ARTERY BYPASS GRAFT (CABG) WAS RECOMMENDED. ON (B)(6) 2014, THE PATIENT WAS TREATED WITH TWO CABG FROM INTERNAL MAMMARY ARTERY (IMA) TO RCA AND SAPHENOUS VEIN GRAFT (SVG) TO RIGHT AC MARGINAL. ON (B)(6) 2013 THE PATIENT EXPIRED OF CARDIAC ARREST. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64846 MULTI-LINK VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death