BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 732015 · Received June 21, 2006

    Report

    Report Number
    2024168-2006-00368
    Event Type
    Injury
    Date Received
    June 21, 2006
    Date of Event
    May 6, 2006
    Report Date
    May 26, 2006
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT AND DEVICE CODES IN H10 WERE CODED BY THE MANUFACTURER. INTERNAL FILE NUMBER - 83109/1: DURING PROCESSING OF THIS COMPLAINT, QUALITY ASSURANCE ATTEMPTED TO OBTAIN COMPLETE EVENT INFORMATION, INCLUDING PATIENT INFORMATION AND PATIENT STATUS, FROM THE HOSPITAL, FIELD CONTACT OR DISTRIBUTOR.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISLODGED STENT/MEDICAL INTERVENTION. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT COULD NOT CROSS WHILE ADVANCING THE STENT TO THE RCA. IT WAS DECIDED TO PULL BACK THE STENT AND WHEN THE STENT DELIVERY SYSTEM HAD BEEN REMOVED, IT WAS REALIZED THAT THE STENT WAS DISLODGED AND FLOATING IN THE OSTIAL OF THE RCA. THERE WAS TIME TO SNARE OUT THE STENT BECAUSE THE PATIENT WAS GOING INTO A CARDIAC ARREST. THEREFORE THEY HAD DECIDED TO DEPLOY ANOTHER STENT TO OPPOSE THE VISION STENT TO THE ARTERIAL WALL. IT WAS REPORTED THE THE PATIENT DIED WITHIN 24 HOURS AFTER THE PROCEDURE. HOWEVER, THE PATIENT DEATH WAS NOT DUE TO THE PROCEDURE OR THE DEVICE. THE PATIENT HAD LIVER CANCER AND DIED FROM LIVER FAILURE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA 6020731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| R