BEUDAMED
    FDA Adverse Event Death Summary report: N

    XAXT CAROTID STENT SYSTEM

    MDR report key: 1019347 · Received March 24, 2008

    Report

    Report Number
    9616695-2008-00032
    Event Type
    Death
    Date Received
    March 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS, ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: WEI ZHOU, MD., PETER H. LIN, MD, PANAGIOTOS KOUGIAS, MD, HOSAM F. EL-SAYED, MD, ALAN B. LUMSDEN, MD, TITLED: "ULTRASOUND CRITERIA FOR SEVERE IN-STENT RESTENOSIS FOLLOWING CAROTID ARTERY STENTING." JOURNAL OF VASCULAR SURGERY 2008; 47:74-80.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: DEATH. TIME OF AE: PERIOPERATIVE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS PERFORMED TO EVALUATE THE ULTRASOUND CRITERIA FOR SEVERE IN-STENT RESTENOSIS FOLLOWING CAROTID ARTERY STENTING (CAS) WITHIN 282 CONSECUTIVE CAS PROCEDURES IN 256 PATIENTS. REPORTEDLY, FOUR PERIOPERATIVE DEATHS OCCURRED. THE ARTICLE DOES NOT CORRELATE THE REPORTED PATIENT DEATHS TO A SPECIFIC STENT SYSTEM (SPECIFIC MANUFACTURER NOT IDENTIFIED) AND NO DEVICE MALFUNCTION WAS DESCRIBED. THE ABBOTT AND COMPETITOR STENTS AND EPDS WERE PROVIDED AND IT IS BELIEVED THAT THEY WERE USED AS SYSTEMS. ABBOTT RX ACCULINK/RX ACCUNET, ABBOTT XACT/EMBOSHIELD AND BOSTON SCI WALLSTENT/FILTERWIRE FOR THE CAS PROCEDURES. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death ABBOTT RX ACCUNET| EPD: BOSTON SCI FILTERWIRE| STENTS: 224 BOSTON SCI WALLSTENT| 30 ABBOTT XACT| 28 ABBOTT RX ACCULINK| ABBOTT EMBOSHIELD