BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2060102 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02648
    Event Type
    Death
    Date Received
    April 15, 2011
    Date of Event
    February 19, 2011
    Report Date
    March 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE RX ACCULINK INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, IT WAS REPORTED THAT THE DEATH CERTIFICATE LISTS THE CAUSE OF DEATH AS CARDIAC ARRHYTHMIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST AN UNEVENTFUL STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT WAS CONFUSED AND FATIGUED. THE NEXT DAY THE PATIENT WAS ANEMIC AND WAS TRANSFUSED WITH 2 UNITS OF PLASMA AND RED BLOOD CELLS. THE PATIENT WAS AMBULATING IN THE ROOM WITH THE ASSISTANCE OF A WALKER AND NEUROLOGICAL STATE WAS UNCHANGED FROM PREOPERATIVE STATE. THE PATIENT WAS DISCHARGED BACK TO THE ASSISTED LIVING CENTER 2 DAYS POST PROCEDURE AND WAS REPORTED TO HAVE EXPIRED THE NEXT DAY. THE CAUSE OF DEATH WAS NOT SPECIFIED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0101361

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death HEPARIN