BEUDAMED
    FDA Adverse Event Other Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1003520 · Received February 19, 2008

    Report

    Report Number
    3004742046-2008-00038
    Event Type
    Other
    Date Received
    February 19, 2008
    Date of Event
    July 22, 2007
    Report Date
    January 25, 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
    NJ, US
    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: BRAJESH K. LAL; "PATTERNS OF IN-STENT RESTENOSIS AFTER CAROTID ARTERY STENTING: CLASSIFICATION AND IMPLICATIONS FOR LONG-TERM OUTCOME" JOURNAL OF VASCULAR SURGERY 2007; 46:833-40.

    Description of Event or Problem · 1

    SYMPTOMS: IN-STENT RESTENOSIS. TIME OF SYMPTOMS/AE: AFTER THE PROCEDURE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS CONDUCTED TO OBSERVE THE DEVELOPMENT OF IN-STENT RESTENOSIS (ISR) IN 255 PTS WHO UNDERWENT CAROTID ARTERY STENTING. REPORTEDLY, DURING A MEAN FOLLOW-UP OF 19.3 MONTHS, SOME PTS DEVELOPED ISR OF EQUAL OR GREATER THAN 40% WHICH WERE SUCCESSFULLY TREATED WITH ANGIOPLASTY WITH OR WITHOUT STENT IMPLANTATION WHEN THEIR ISR REACHED A THRESHOLD OF 80% OR GREATER. THIRTEEN OF THE PTS HAD AN ISR GREATER THAN 80% WHICH REQUIRED REVASCULARIZATION. ONE OF THE PTS WITH ISR LESIONS HAD NO PROGRADE FLOW AND NO LUMEN IDENTIFIED (OCCLUDED) ALTHOUGH WAS ASYMPTOMATIC. THE REMAINING 72 PTS HAD ISR LESIONS LESS THAN 80% WHICH DID NOT REQUIRE REVASCULARIZATION. BOTH ACCULINK AND WALLSTENT (BOSTON SCIENTIFIC N=37) DEVICES WERE USED. THE ARTICLE DOES NOT HAVE A DIRECT CORRELATION OF THE ISR GROUP AS TO WHICH COMPANY'S STENTS WERE TREATED FOR IN-STENT RESTENOSIS AND WHICH WERE NOT REVASCULARIZED. NO ADD'L PT EFFECTS OR INFO WAS 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 70 YR Required Intervention STENT: 48 ABBOTT RX ACCULINK| 37 BOSTON SCIENTIFIC WALLSTENT