BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1876685 · Received October 15, 2010

    Report

    Report Number
    2024168-2010-02182
    Event Type
    Death
    Date Received
    October 15, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 27, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECT OF DEATH IS LISTED IN THE VISION INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE PT EVENT 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 MANUFACTURE OR DESIGN. THE 3.0 X 12MM VISION (PART# 1007842-12, LOT 0030841) IS BEING FILED UNDER A SEPARATE MFR #.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED WITH CARDIOGENIC SHOCK DUE TO MYOCARDIAL INFARCT AND DURING THE PROCEDURE WHILE INSERTING THE STENT DELIVERY SYSTEM (SDS) IN THE PT ANATOMY, UNDER FLUOROSCOPY, THE PHYSICIAN COULD NOT SEE THE STENT ON THE BALLOON/SDS. THE STENT IMPLANT WAS LOCATED STILL WITHIN THE PROTECTIVE SHEATH. REPORTEDLY A SECOND 3.0 X 12 MM VISION STENT WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN STATED THAT THE PT DIED SOON AFTER THE PROCEDURE FROM CARDIOGENIC SHOCK DUE TO MYOCARDIAL INFARCT WITH OCCLUSION OF THE CIRCUMFLEX ARTERY. THERE WAS NO ADDITIONAL INFO PROVIDED. THE DATE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9080441

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death STENT: 3.0 X 12MM VISION| (PART# 1007842-12, LOT# 0030841)