BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK VISION CORONARY STENT SYSTEM

    MDR report key: 1981660 · Received February 8, 2011

    Report

    Report Number
    2024168-2011-00751
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE CUSTOMER REPORTED 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. IT SHOULD BE NOTED THAT THE VISION INSTRUCTIONS FOR USE (IFU) WARNS THAT, PERSONS ALLERGIC TO L-605 COBALT CHROMIUM ALLOY (INCLUDING THE MAJOR ELEMENTS COBALT, CHROMIUM, TUNGSTEN, NICKEL) MAY SUFFER AN ALLERGIC REACTION TO THIS IMPLANT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 AN UNKNOWN VISION IMPLANTED IN (B)(6) 2010, THE EXACT DATE WAS NOT PROVIDED. THE PATIENT HAS EXPERIENCED A RASH AND IS CURRENTLY BEING TREATED BY A DERMATOLOGIST. THE DERMATOLOGIST STATES THAT THE PATIENT MAY BE ALLERGIC TO THE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other