BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 933050 · Received October 19, 2007

    Report

    Report Number
    3004742046-2007-00332
    Event Type
    Death
    Date Received
    October 19, 2007
    Date of Event
    August 28, 2007
    Report Date
    September 24, 2007
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE RX ACCUNET EMBOLIC PROTECTION SYSTEM, PART # 1011649-55, LOT# 7031351 IS INDICATED AND IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    STUDY EVENT. DEVICE MALFUNCTION: INACCURATE STENT DELIVERY. TIME OF MALFUNCTION: DURING THE PROCEDURE. TIME OF SYMPTOMS/AE: 19 DAYS AFTER THE PROCEDURE. SYMPTOMS/AE: DEATH. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENT PROCEDURE, THE STENT WAS INACCURATELY DELIVERED THAT THE HEAVILY CALCIFIED TARGET LESION. A DISSECTION WAS NOTED DURING THE PROCEDURE. A SECOND EMBOLIC PROTECTION DEVICE WAS PLACED, AND A SECOND STENT WAS SUCCESSFULLY PLACED PROXIMAL TO THE FIRST STENT TO COVER THE LESION AND THE DISSECTION. DIFFICULTY WAS ENCOUNTERED DURING REMOVAL OF THE EMBOLIC PROTECTION DEVICE WITH THE RECOVERY CATHETER. THE LOW PROFILE FLEXIBLE TIP RECOVERY CATHETER WAS SUCCESSFUL IN RETRIEVAL OF THE FILTER BASKET. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS. THE PATIENT WAS DISCHARGED TO HOME IN 2007. NINETEEN DAYS POST-HOSPITALIZATION, ON THE FOLLOWING MONTH, THE PATIENT "PASSED AWAY IN HER SLEEP PEACEFULLY." THE CAUSE OF DEATH IS UNKNOWN. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 6081651

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death| R BIVALIRUDIN| RX ACCUNET EPD (X2)| RX ACCULINK