BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM

    MDR report key: 1719910 · Received May 3, 2010

    Report

    Report Number
    2024168-2010-00903
    Event Type
    Death
    Date Received
    May 3, 2010
    Date of Event
    February 28, 2010
    Report Date
    April 8, 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
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). PERFORATION AND DEATH, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MFR, DESIGN OR LABELING. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: VESSEL PERFORATION, CARDIAC TAMPONADE, DEATH. TIME OF ADVERSE EVENT: AFTER BALLOON DILATATION. IT WAS REPORTED THAT A PT WITH ACUTE CORONARY SYNDROME PRESENTED FOR A STENTING PROCEDURE. DURING THE UNSPECIFIED CORONARY ARTERY STENTING PROCEDURE, IN A 100% STENOSED ARTERY, AN UNSPECIFIED WIRE WAS PLACED AND AN UNSPECIFIED BALLOON DILATED THE VESSEL. SLIGHT STAINING WAS NOTICED. NO FLOW IN THE ARTERY CONTINUED. THE STENT WAS PLACED IN THE ARTERY AND SUCCESSFULLY DEPLOYED. CARDIAC TAMPONADE FOLLOWED. PERICARDIOCENTESIS WAS PERFORMED. SURGERY WAS DECLINED. AT AN UNSPECIFIED TIME, THE PT EXPIRED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9072431

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R