BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT

    MDR report key: 25246478 · Received May 21, 2026

    Report

    Report Number
    2024168-2026-02105
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    July 31, 2000
    Report Date
    May 21, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A PRODUCTION RECORD REVIEW AND A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBER WAS NOT REPORTED. A CONCLUSIVE CAUSE FOR THE REPORTED STROKE/CVA AND SERIOUS INJURY/ ILLNESS/ IMPAIRMENT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF STROKE/CVA IS LISTED IN THE XACT CAROTID STENT SYSTEM INFORMATION FOR PRESCRIBERS AS ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH CAROTID STENTS AND EMBOLIC PROTECTION SYSTEMS. THE REPORTED PATIENT EFFECT OF STROKE/CVA IS LISTED IN THE XACT CAROTID STENT SYSTEM INFORMATION FOR PRESCRIBERS AS ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH CAROTID STENTS AND EMBOLIC PROTECTION SYSTEMS. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. B3: ESTIMATED DATE D4: THE UDI # IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. LITERATURE ATTACHMENT: ARTICLE, TITLED "ASSESSING THE IMPACT OF DISTAL PROTECTION FILTER DESIGN CHARACTERISTICS ON 30-DAY OUTCOMES OF CAROTID ARTERY STENTING PROCEDURES"

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE SUMMARY THAT THE OBJECTIVE WAS TO REVIEW RETROSPECTIVELY THE RECORDS OF PATIENTS TREATED WITH CAROTID ARTERY STENTING (CAS) TO INVESTIGATE THE POTENTIAL CORRELATIONS BETWEEN CLINICAL VARIABLES, DISTAL PROTECTION FILTER (DPF) TYPE AND CHARACTERISTICS, AND 30-DAY PERI-/POSTPROCEDURAL OUTCOMES. THIS IS A MULTICENTER, SINGLE-ARM, NONRANDOMIZED RETROSPECTIVE STUDY OF PATIENTS WHO UNDERWENT FILTER-PROTECTED CAS IN THE PITTSBURGH, PENNSYLVANIA, REGION BETWEEN JULY 2000 AND MAY 2011. ANALYSIS OF PERI-/POSTPROCEDURAL COMPLICATIONS INCLUDED MYOCARDIAL INFARCTION, TRANSIENT ISCHEMIC ATTACKS (TIA), STROKE, DEATH, AND A COMPOSITION OF ALL ADVERSE EVENTS (AES). THE INCLUSION CRITERIA WERE BASED ON PATIENTS WHO UNDERWENT PROTECTED CAS WITH A DISTAL PROTECTION FILTER (DPF) AND HAD A COMPLETE REGISTERED MEDICAL HISTORY AND DOCUMENTED 30-DAY FOLLOW-UP. PATIENTS WERE CONSIDERED SYMPTOMATIC IF THEY HAD EXPERIENCED AMAUROSIS FUGAX, TIA, OR STROKE (INCLUDES BOTH MINOR AND MAJOR STROKES) WITHIN 60 DAYS BEFORE THE CAS PROCEDURE. ALL DOCUMENTED COMPLICATIONS THAT OCCURRED PERIPROCEDURALLY AND POSTPROCEDURALLY (WITHIN 30 DAYS) WERE NOTED AND RECORDED. THE STENT TYPES INCLUDED ACCULINK (ABBOTT VASCULAR, SANTA CLARA, CALIF), PRECISE (CORDIS ENDOVASCULAR, MIAMI LAKES, FLA), WALLSTENT (BOSTON SCIENTIFIC, NATICK, MASS), XACT (ABBOTT VASCULAR), PROTÉGÉ (EV3 ENDOVASCULAR INC, PLYMOUTH, MINN), AND NEXSTENT (ENDOTEX INTERVENTIONAL SYSTEMS, CUPERTINO, CALIF). THE FILTER TYPES INCLUDED ACCUNET (ABBOTT VASCULAR), ANGIOGUARD (CORDIS ENDOVASCULAR), FILTERWIRE (BOSTON SCIENTIFIC), EMBOSHIELD (ABBOTT VASCULAR), SPIDER (EV3 ENDOVASCULAR INC), AND FIBERNET (LUMEN BIOMEDICAL INC, MAPLE GROVE, MINN). IT WAS FOUND THAT ACCUNET AND EMBOSHIELD ARE ASSOCIATED WITH TIA, CVA AND DEATH. A TOTAL OF 1150 CAS RECORDS WERE REVIEWED, OF WHICH 713 PATIENTS AND 731 PROCEDURES MET THE INCLUSION CRITERIA. OF THE 731 RECORDS, THERE WERE 19 TIAS (2.6%), 38 STROKES (5.2%), ONE MI (0.1%), 19 DEATHS (3.6%), AND A TOTAL OF 61 PATIENTS WITH AES (8.3%). SYMPTOMATIC PATIENTS WHO UNDERWENT CAS WITH A CLOSED CELL STENT (NEXSTENT, ENDOTEX, WALLSTENT, AND XACT, BUT NOT PRECISE, SMART, CORDIS, OR ACCULINK) HAVE A HIGHER RISK OF AE AND PERI-/POSTPROCEDURAL STROKE. ADDITIONAL INFORMATION CAN BE FOUND IN THE ARTICLE "ASSESSING THE IMPACT OF DISTAL PROTECTION FILTER DESIGN CHARACTERISTICS ON 30-DAY OUTCOMES OF CAROTID ARTERY STENTING PROCEDURES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524447 XACT STENT, CAROTID NIM ABBOTT VASCULAR INC. UNK XACT

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Disability