BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 932975 · Received October 19, 2007

    Report

    Report Number
    3004742046-2007-00331
    Event Type
    Injury
    Date Received
    October 19, 2007
    Date of Event
    August 28, 2007
    Report Date
    September 24, 2007
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT, AND DEVICE INFO. STUDY EVENT; THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE RX ACCULINK CAROTID STENT SYSTEM, LOT# 6081651 IS INDICATED IS BEING FILED UNDER A SEPARATE MFR REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULTY IN REMOVAL OF FILTER BASKET. TIME OF MALFUNCTION: DURING THE PROCEDURE. TIME OF SYMPTOMS/AE: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENT PROCEDURE, THE STENT WAS INACCURATELY DELIVERED AT 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 UNK. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7031351

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention OTHER: BIVALIRUDIN| STENT: RX ACCULINK (X2)