BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1837251 · Received September 14, 2010

    Report

    Report Number
    3004742046-2010-00414
    Event Type
    Death
    Date Received
    September 14, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 20, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CEREBROVASCULAR ACCIDENT (STROKE), DEATH, INTRACRANIAL HEMORRHAGE, NEUROLOGICAL DEFICIT/ DYSFUNCTION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE ACCULINK INSTRUCTIONS FOR USE (IFU) AND ARE KNOWN ADVERSE EVENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING OR DESIGN AND THE TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT THE PATIENT WAS ADMITTED ON (B)(6) 2010, WITH UNSTABLE ANGINA. DIAGNOSTIC LEFT HEART CATHETERIZATION REVEALED MULTIVESSEL DISEASE REQUIRING CORONARY ARTERY BYPASS GRAFT (CABG) AND CAROTID ANGIOGRAM SHOWED RIGHT INTERNAL CAROTID ARTERY (RICA) STENOSIS. CONCOMITANT MEDICATION INCLUDED ASPIRIN, PLAVIX, AND IV HEPARIN WERE STARTED ON (B)(6)2010. ON (B)(6)2010, THE RX ACCULINK STENT WAS UNEVENTFULLY IMPLANTED IN THE RICA. THE PATIENT WAS TRANSFERRED DIRECTLY TO THE OPERATING ROOM AND THE PLANNED CABG X5 WAS PERFORMED. PLAVIX WAS STARTED POST OPERATIVELY; HOWEVER, LAB TESTS INDICATED THE PATIENT WAS NOT RESPONDING AND PLAVIX WAS REPLACED WITH EFFIENT ON (B)(6)2010. ON POSTOPERATIVE DAY 4, THE PATIENT HAD PULMONARY CRACKLES, ELEVATED WHITE BLOOD CELL COUNT, AND WAS STARTED ON EMPIRIC ANTIBIOTICS. ON (B)(6)2010, THE PATIENT DEVELOPED RESPIRATORY FAILURE AND WAS PLACED ON BIPAP. ON (B)(6)2010, THE PATIENT PULLED OFF HIS FACE MASK AND WENT INTO RESPIRATORY ARREST FOR APPROXIMATELY 10 MINUTES. THE PATIENT WAS INTUBATED AND PLACED ON 24-HOUR COOLING PROTOCOL. AFTER WARMING WAS STARTED, THE PATIENT REMAINED UNRESPONSIVE DUE TO GLOBAL HYPOXIC BRAIN INJURY SECONDARY TO RESPIRATORY ARREST. CT SCAN OF THE HEAD, DONE ON (B)(6)2010 REVEALED INTRAPARENCHYMAL BRAINSTEM HEMORRHAGE EXTENDING INTO THE FOURTH VENTRICLE, FINDINGS CONSISTENT WITH A GLOBAL ANOXIC ISCHEMIC EVENT, AND EXTENSIVE CEREBRAL EDEMA WITH EVIDENCE OF TRANSTENTORIAL HERNIATION. THE PATIENT DIED ON (B)(6)2010. THE TREATING PHYSICIANS ASSESSED THE BLEED WAS POSSIBLY DUE TO EFFIENT. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9121651

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death EMBOLIC PROTECTION: EMBOSHIELD NAV 6| HEPARIN