BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1667462 · Received April 23, 2010

    Report

    Report Number
    3004742046-2010-00165
    Event Type
    Injury
    Date Received
    April 23, 2010
    Date of Event
    March 19, 2010
    Report Date
    March 30, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE RX ACCULINK PART# 1011339-30, LOT# 8091051 INDICATED IS BEING FILED UNDER THE SAME MEDWATCH MFR NUMBER. EVAL SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVAL. NON-STROKE NEUROLOGICAL EVENTS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE. THE ADVERSE EVENT MAY EVEN OCCUR DURING OR AFTER THIS TYPE OF PROCEDURE WHEN THE DEVICE FUNCTIONS NORMALLY. IN THIS INCIDENT, THE PT WAS FINE AFTER THE CAROTID PROCEDURE. THE EVENT STARTED WHEN THE PT WAS WAKING FROM THE CORONARY ARTERY BYPASS GRAFT PROCEDURE. THE PT WAS AGITATED AND RESTLESS, WAS PUT BACK DOWN, THEN UPON RE-AWAKENING REMAINED AGITATED AND CONFUSED. THERE WAS NO KNOWN DEVICE PROBLEM REPORTED AND NO PRODUCT QUALITY DISCREPANCIES REPORTED DURING INSPECTION PRIOR TO USE AND PREPARATION. IN THIS CASE, THE INFO AVAILABLE AND RELEVANT MFG RECORDS ARE NOT SUFFICIENT TO DETERMINE RELATION BETWEEN PT ADVERSE EVENT AND THE ABBOTT VASCULAR DEVICE QUALITY. THE EVENT IS POSSIBLY RELATED TO THE OPERATIONAL CONTEXT OF THE DEVICE.

    Description of Event or Problem · 1

    ADVERSE EVENT: NEUROLOGICAL DEFICITS GREATER THAN 24 HOURS. TIME OF ADVERSE EVENT: THREE DAYS POST PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED THAT 3 DAYS AFTER A LEFT COMMON CAROTID ARTERY STENTING PROCEDURE AND DIRECTLY POST A 5 VESSEL CORONARY ARTERY BYPASS GRAFT SURGERY (CABG), THE PT EXPERIENCED SOME AGITATION AND CONFUSION. CTS WERE NEGATIVE FOR ACUTE PROCESS. REPORTEDLY, THE CONFUSION WAS MOST LIKELY RELATED TO THE CABG AND NOT THE CAROTID ARTERY STENTING PROCEDURE. THE PT REMAINS CONFUSED AND HOSPITALIZED AND IS PENDING PLACEMENT IN A NURSING HOME. ALTHOUGH REQUESTED, THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9112351

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O| S EMBOLIC PROTECTION: RX ACCUNET| PART# 1011334-65, LOT# 9081451| BIVALIRUDIN| RX ACCULINK PART# 1011339-30, LOT# 8091051