BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1984228 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00797
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    April 19, 2010
    Report Date
    January 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. (B)(4). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED THROMBOSIS IS A KNOWN ADVERSE EVENT LISTED IN THE VISION INSTRUCTIONS FOR USE (IFU). 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A 3.5 X 28 MM VISION IMPLANTED IN 2010. THE EXACT DATE WAS NOT PROVIDED. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2010 WITH ANGINA. AN ANGIOGRAPHY WAS PERFORMED, NOTING 100% OCCLUSION WITH THROMBUS OF PREVIOUSLY PLACED STENT. DILATATION WAS PERFORMED WITH A 3.0 X 20 MM NC MERLIN, BUT THERE STILL APPEARED TO BE DIFFUSE THROMBUS IN THE DISTAL VESSEL. THROMBECTOMY WAS PERFORMED, REMOVING A LARGE AMOUNT OF CLOT, AND FLOW IMPROVED. A 2.0 X 18 MM MULTI-LINK MINI VISION WAS THEN DEPLOYED IN THE DISTAL VESSEL, AND A 3.0 X 18 MM MULTI-LINK VISION WAS PLACED BETWEEN THE 2.0 X 18 MM MINI VISION STENT AND THE PREVIOUSLY PLACED 3.5 X 28 MM VISION STENT. TIMI FLOW WAS NOTED TO BE AT III AND THE PATIENT WAS DISCHARGED WITH MEDICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0022541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention