BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2933894 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00471
    Event Type
    Death
    Date Received
    January 29, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED BASED ON DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATE BASED ON DATE OF PUBLICATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF DEATH, NEUROLOGICAL DEFICIT DYSFUNCTION, AND TRANSIENT ISCHEMIC ATTACK (TIA) ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. BETWEEN 2008 AND 2011, 141 PATIENTS (119 MEN; MEAN AGE (B)(6)) WITH ATHEROSCLEROTIC ICA STENOSIS > 70% WERE PROSPECTIVELY ENROLLED IN THE STUDY. ABOUT TWO THIRDS OF THE STENTS PLACED WERE ACCULINK (97, 68.9%), WITH CAROTID NON-ABBOTT STENTS IN 44 (31.2%); 3 PATIENTS REQUIRED 2 STENTS. FOUR (2.8%) PATIENTS DEVELOPED A SHORT-LASTING IPSILATERAL TIA (<15 MINUTES AFTER STENT DEPLOYMENT; TWO OF THEM HAD PLAQUE WITH PATHOLOGICAL INTIMAL THICKENING, WHILE THE OTHER TWO WERE OF THE CALCIFIED THIN-CAP FIBROATHEROMA TYPE. THREE OF THE 4 PATIENTS HAD OPEN-CELL STENTS. THE COMPOSITE RATE OF DEATH/DISABLING STROKE WAS 2.1% (3/141);THERE WERE NO MINOR STROKES OR MYOCARDIAL INFARCTIONS. ADDITIONAL INFORMATION WAS RECEIVED WHICH CLARIFIED THE DEATH/DISABLING STROKE (3/141) WHICH STATES, ONE OF THE PATIENTS HAD A CEREBRAL HYPERPERFUSION SYNDROME AND THE PATIENT DIED (OPEN-CELL STENT). THE OTHER TWO PATIENTS HAD MINOR STROKE (1 OPEN AND 1 CLOSED CELL STENT). NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38610 ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death