BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 25246715 · Received May 21, 2026

    Report

    Report Number
    2024168-2026-02107
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    July 31, 2000
    Report Date
    May 21, 2026
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NTE
    PMA / PMN Number
    K081549
    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 PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED, AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, TRANSIENT ISCHEMIC ATTACK, AND STROKE, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, TRANSIENT ISCHEMIC ATTACK, AND STROKE, ARE LISTED IN THE RX ACCUNET EMBOLIC PROTECTION SYSTEM INSTRUCTION FOR USE AS KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. 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. THE ADDITIONAL PATIENT EFFECT OF DEATH REPORTED IN THE ARTICLE IS CAPTURED UNDER A SEPARATE MEDWATCH REPORT. 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 PERI-PROCEDURALLY AND POST-PROCEDURALLY (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
    559329 ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR UNK RX ACCUNET

    Patients

    Seq Age Sex Outcome Treatment
    1