BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1728351 · Received June 15, 2010

    Report

    Report Number
    2024168-2010-01186
    Event Type
    Death
    Date Received
    June 15, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 21, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED ADVERSE 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, DESIGN OR LABELING.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. TIME OF ADVERSE EVENT: POST STENTING PROCEDURE. IT WAS REPORTED THAT AN OCCLUSION IN THE PROXIMAL PORTION OF THE MILDLY TORTUOUS AND CALCIFIED RCA WAS TREATED USING A 3.0X15 RX VISION. ONE DAY POST STENTING PROCEDURE, THE PATIENT DIED. THE CAUSE OF THE PATIENT'S DEATH WAS NOT REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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 9120941

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death INTEGRILLIN| UNSPECIFIED DILATATION CATHETER