BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 989616 · Received January 31, 2008

    Report

    Report Number
    9616695-2008-00006
    Event Type
    Injury
    Date Received
    January 31, 2008
    Date of Event
    July 20, 2007
    Report Date
    January 9, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: MARK K ESKANDARI, KATHERINE E. BROWN, MELINA R. KIBBE, MARK D. MORASCH, JON S. MATSUMURA, WILLIAM H. PEARCE; "RESTENOSIS AFTER CAROTID STENT PLACEMENT IN PATIENTS WITH PREVIOUS NECK IRRADIATION OR ENDARTERECTOMY"; J VASE INTERV RADIOL 2007; 18: 1368-1374. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. TIME OF SYMPTOMS/AE: AFTER CAROTID STENT PROCEDURE. SYMPTOMS/AE: STROKE, OCCLUSION, STENOSIS. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS PERFORMED TO EVALUATE RESTENOSIS IN PATIENTS WITH PREVIOUS NECK IRRADIATION OR ENDARTERECTOMY WITH DE NOVO LESIONS DURING 269 CAROTID ARTERY STENT PROCEDURES AFTER STENT PLACEMENT. REPORTEDLY, THE RESULTS FOR THE 30-DAY EVENT RATE FOR THE ENTIRE GROUP INCLUDED THREE MAJOR IPSILATERAL STROKE, THREE MINOR POSTERIOR STROKE, TWO ASYMPTOMATIC OCCLUSION TREATED MEDICALLY, AND FIVE IN-STENT RESTENOSIS CASES OF AT LEAST 80%, TREATED WITH REPEAT ANGIOPLASTY WITH OR WITHOUT STENT IMPLANTATION. NO PROCEDURAL OR POST-OPERATIVE COMPLICATIONS OCCURRED AFTER REPEAT INTERVENTIONS. THE ARTICLE INDICATED STENT SYSTEMS FROM FOUR MANUFACTURES WERE USED. THE ARTICLE DOES NOT CORRELATE THE REPORTED PATIENT OUTCOMES TO A SPECIFIC STENT SYSTEM (SPECIFIC MANUFACTURER NOT IDENTIFIED). THE GUIDANT/ABBOTT DEVICES USED WERE RX ACCULINK (104 DEVICES) AND XACT (20 DEVICES). NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention DIL CATH: GAZELLE 4.0MM (PRE-DIL)| GENESIS| VIVEXX| SMART| GAZELLE 5.0MM (POST-DIL)| STENT: PRECISE| VIABAHN| OTHER: HEPARIN| EXPRESS