BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT

    MDR report key: 20137980 · Received September 4, 2024

    Report

    Report Number
    2024168-2024-10417
    Event Type
    Death
    Date Received
    September 4, 2024
    Date of Event
    February 28, 2023
    Report Date
    October 23, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 ELECTRONIC LOT HISTORY RECORD (ELHR) REVIEW AND A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBER WAS NOT REPORTED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XACT CAROTID STENT SYSTEM INFORMATION FOR PRESCRIBERS AS ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH CAROTID STENTS AND EMBOLIC PROTECTION SYSTEMS. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. 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. B2 - DATE OF DEATH: ESTIMATED AS (B)(6) 2024. B3 - DATE OF EVENT: ESTIMATED AS 03/01/2024. D4 - PRIMARY UDI NUMBER: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE ADDITIONAL PATIENT EFFECTS LISTED IN THE REPORT ARE CAPTURED UNDER A SEPARATE MEDWATCH REPORT. LITERATURE ATTACHMENT ARTICLE TITLE: "POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT CAROTID STENT AND EMBOLIC PROTECTION SYSTEMS".

    Additional Manufacturer Narrative · 0

    D4: PRIMARY UDI NUMBER: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. CORRECTIONS: A2: AGE AT TIME OF EVENT: UPDATED FROM 71 TO 70. B2: DATE OF DEATH: ESTIMATED, UPDATED FROM (B)(6) 2024 TO (B)(6) 2023. B3: DATE OF EVENT: ESTIMATED, UPDATED FROM 3/1/2024 TO 2/28/2023. THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE PMCF ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS LITERATURE TITLE "POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT CAROTID STENT AND EMBOLIC PROTECTION SYSTEMS".

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT PATIENT DEATH. IT WAS REPORTED THROUGH THE PMCF (POST-MARKET CLINICAL FOLLOW-UP) REPORT, THAT ABBOTT OBTAINED DATA FROM THE VASCULAR QUALITY INITIATIVE (VQI) REGISTRY ACROSS UNITED STATES (US). OVERALL, THE DATA PRESENTED THROUGH THIS METHODOLOGY CONFIRMS THE SAFETY AND PERFORMANCE OF RX ACCULINK CAROTID STENT SYSTEM (CSS), X.ACT CSS, AND EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS). ADVERSE PATIENT EFFECTS FOR X.ACT INCLUDE DEATH, TRANSIENT ISCHEMIC ATTACK, STROKE, MYOCARDIAL INFARCTION, ACCESS SITE COMPLICATIONS, RE-STENOSIS, REVASCULARIZATION, SURGERY AND RE-HOSPITALIZATION.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THROUGH AN UPDATED VERSION OF THE POST-MARKET CLINICAL FOLLOW-UP (PMCF) REPORT. DATA WAS OBTAINED THROUGH REAL-WORLD DATA (RWD). ADVERSE PATIENT EFFECTS FOR THE X.ACT CAROTID STENT SYSTEM (CSS) INCLUDED: DEATH, MYOCARDIAL INFARCTION, STROKE, RESTENOSIS AND TRANSIENT ISCHEMIC ATTACK, WITH TREATMENT INCLUDING HOSPITALIZATION AND CAROTID ARTERY RE-STENTING. PROCEDURES WERE PERFORMED FROM (B)(6) 2021 TO (B)(6) 2021. TWO-YEAR ENDPOINT RATES WERE CAPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385868 XACT STENT, CAROTID NIM ABBOTT VASCULAR INC. UNK XACT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death