BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 927775 · Received October 15, 2007

    Report

    Report Number
    3004742046-2007-00319
    Event Type
    Injury
    Date Received
    October 15, 2007
    Date of Event
    September 26, 2007
    Report Date
    September 26, 2007
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NFA
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PT, AND DEVICE INFORMATION. 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 PART # 1011342-40, LOT #5110751 REFERENCED IN IS BEING FILED UNDER MEDWATCH MFR #3004742046-2007-00317. THE RX ACCULINK PART # 1011342-40, LOT #5110751 REFERENCED IS BEING FILED UNDER MEDWATCH MFR #3004742046-2007-00318.

    Description of Event or Problem · 1

    PRODUCT MALFUNCTION: NONE. SYMPTOMS/AE: STROKE. TIME OF AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A LEFT COMMON CAROTID ARTERY STENTING PROCEDURE USING TWO RX ACCULINK STENTS, THE PT SUFFERED A STROKE. DURING POST STENT DILATATION, THE PT BECAME HEMIPLEGIC ON THE RIGHT SIDE WITH DECREASED SPEECH. THE ANGIOGRAM SHOWED A PATENT STENT WITH PRESERVED INTRACRANIAL CIRCULATION. THE PT WAS TAKEN FOR A CT SCAN WHICH SHOWED NO ACUTE BLEED. THE NEUROLOGIST FELT IT WAS AN ISCHEMIC EVENT. THE PT HAD CHRONIC MICROVASCULAR SMALL VESSEL DISEASE AND DID NOT TOLERATE THE BALLOON INFLATIONS. THE PT WAS APHASIC, DYSPHAGIC AND WAS HAVING DIFFICULTY KEEPING HIS AIRWAY CLEAR. ONE DAY POST PROCEDURE, THE PT WAS DISCHARGED TO A NEURO INTENSIVE CARE UNIT. EIGHT DAYS POST PROCEDURE, HE WAS TRANSFERRED TO A STEPDOWN UNIT. THE PT CONTINUES TO HAVE DIFFICULTY KEEPING HIS AIRWAY CLEAR, IS ON BIPAP AND IS BEING SUCTIONED FREQUENTLY. A PEG TUBE WAS PLACED AND FEEDINGS WERE STARTED. IF THE PT CAN MAINTAIN HIS RESPIRATORY STATUS, HE WILL BE TRANSFERRED TO A REHABILITATION FACILITY. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NFA ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7083051

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability RX ACCULINK PART # 1011342-40| HEPARIN| RX ACCULINK PART #1011342-40| DILCATH:BOSTON SCIENTIFIC STERLING 7.0 X 3.0 X 135