BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    MDR report key: 2011164 · Received March 8, 2011

    Report

    Report Number
    2024168-2011-01526
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    April 1, 2010
    Report Date
    February 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 PATIENT EFFECT OF ALLERGIC REACTION/HYPOSENSITIVITY IS ADDRESSED IN THE PRODUCT THE VISION INSTRUCTIONS FOR USE THAT WARNS, 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 EVER SINCE THE VISION STENT WAS IMPLANTED IN AN UNSPECIFIED CORONARY ARTERY, APPROXIMATELY ONE YEAR AGO, THE PATIENT HAS EXPERIENCED PANIC ATTACKS, DIZZINESS, NAUSEA, NIGHT SWEATS AND DAILY HEADACHES THAT HAVE RESULTED IN INABILITY TO WORK. ALTHOUGH THE PATIENT REPORTED NO KNOWN ALLERGIES AND HAS HAD NO ALLERGY TESTING, HE IS CONCERNED THAT THE SYMPTOMS COULD POSSIBLY BE DUE TO ALLERGY FROM THE VISION STENT COMPOSITION. TREATMENT OF THE SYMPTOMS INCLUDE EFFEXOR AND ATIVAN AND ADJUSTMENT OF CARDIOVASCULAR MEDICATIONS. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK OTW VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 8051531

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other ASPIRIN, PLAVIX, LOPRESSOR, COREG, EFEXOR, ATIVAN