BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1004094 · Received February 27, 2008

    Report

    Report Number
    3004742046-2008-00048
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    December 1, 2007
    Report Date
    February 4, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A STUDY NOTED IN AN ARTICLE. NO DEVICES WERE AVAILABLE FOR ANALYSIS. THE PART AND LOT NUMBERS WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ATTACHMENT: MD; TITLED, "MEASUREMENT AND IMPACT OF PROXIMAL AND DISTAL TORTUOSITY IN CAROTID STENTING PROCEDURES". JOURNAL OF VASCULAR SURGERY 2007; 46: 1119-24.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS: STROKE/TIA. TIME OF SYMPTOMS: DURING AND AFTER THE PROCEDURE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS PERFORMED TO EVALUATE THE IMPACT OF ARCH ANGULATION AND PROXIMAL AND DISTAL TORTUOSITY IN A SERIES OF 298 CAROTID ARTERY STENTING (CAS) PROCEDURES. NEUROLOGICAL COMPLICATIONS OCCURRED IN 23 PATIENTS, 16 WERE TRANSIENT ISCHEMIC ATTACKS (TIA'S) AND 7 WERE MINOR STROKES. OF THE 23 PATIENTS COMPLICATIONS SIX WERE REPORTED INTRAPROCEDURAL AND SEVENTEEN POST-PROCEDURAL. NO TREATMENT OR LENGTH OF SYMPTOMS WERE DESCRIBED IN THE ARTICLE. THE ARTICLE DOES NOT CORRELATE THE REPORTED PATIENT OUTCOMES TO A SPECIFIC STENT SYSTEM (SPECIFIC MANUFACTURER NOT IDENTIFIED). THE SYSTEMS USED WERE ABBOTT RX ACCULINK/RX ACCUNET AND BOSTON SCIENTIFIC WALLSTENT/EZ FILTERWIRE FOR THE CAS PROCEDURES. THOUGH REQUESTED, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability GUIDE WIRE: TERUMO STIFF| 126 RX ACCULINKS ABBOTT| 138 RX ACCUNETS ABBOTT| EDI: 160 EZ FILTER BOSTON SCI| STENT: 172 WALLSTENT BOSTON SCI| SHEATH: 8F| GUIDE CATH: MEDTRONIC HS I