BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    MDR report key: 1790755 · Received August 4, 2010

    Report

    Report Number
    2024168-2010-01589
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE VISION INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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, DESIGN OR LABELING. IT WAS REPORTED THAT THE TARGET LESION WAS NOT PRE-DILATED PRIOR TO IMPLANTING THE VISION STENT. IT SHOULD BE NOTED THAT THE IFU STATES TO FIRST "PRE-DILATE THE LESION WITH A PTCA CATHETER." IT IS UNKNOWN HOW DIRECT STENTING CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: THROMBOSIS REQUIRING MEDICAL INTERVENTION. ONSET OF ADVERSE EVENT: FOUR HOURS AFTER THE PROCEDURE. IT WAS REPORTED THAT FOUR HOURS AFTER THE VISION STENT WAS IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY, THE PATIENT EXPERIENCED CHEST PAIN AND WAS FOUND TO HAVE DEVELOPED AN ACUTE STENT THROMBOSIS. A THROMBECTOMY WAS PERFORMED AND MEDICATION WAS GIVEN. THE PATIENT'S CHEST PAIN RESOLVED AND THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. THE TARGET LESION WAS NEITHER PREDILATED, NOR POST DILATED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK OTW VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention