BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2955778 · Received February 11, 2013

    Report

    Report Number
    2024168-2013-00788
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    February 22, 2012
    Report Date
    January 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF OCCLUSION IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE XACT CAROTID STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE OTHER ABBOTT DEVICES OF ACCULINK, AND XPERT AS REFERENCED ARE BEING FILED UNDER SEPARATE MFR NUMBERS.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF AN ARTICLE: IT WAS REPORTED THAT A DUAL-CENTER RETROSPECTIVE STUDY IDENTIFIED A TOTAL OF 382 PATIENTS WHO UNDERWENT CAROTID ARTERY STENTING (CAS) FROM THE TRAN RADIAL APPROACH. CAS WAS SUCCESSFUL IN 347/382 (91%) PATIENTS; THE MEAN AGE WAS 68 +/- 0.5 YEARS AND 249 (70%) WERE MALE. CLINICAL OUTCOME FOR THIS CASE WAS AS FOLLOWS: 23/247(7%) RADIAL ARTERY OCCLUSION; NO MAJOR VASCULAR COMPLICATIONS OCCURRED. NO MYOCARDIAL INFARCTION (MI) OCCURRED. ALTHOUGH OTHER SERIOUS/ADVERSE CLINICAL OUTCOMES WERE REPORTED IN THE ARTICLE, THEY HAVE PREVIOUSLY BEEN REPORTED. THE ABBOTT STENTS UTILIZED WERE AN XACT STENT DEPLOYED IN 177 (51%); XPERT 13 (4%), ACCULINK 10 (3%). THE EMBOLIC PROTECTION DEVICES UTILIZED WERE AN EMBOSHIELD NAV6 192 (55%), EMBOSHIELD 20 (6%), ACCUNET 9 (2%); VIA RIGHT INTERNAL CAROTID ARTERY (RICA) A TADII GUIDE WIRE 10 (5%), SUPRACORE 11 (6%); VIA LEFT INTERNAL CAROTID ARTERY (LICA) A TADII 11 (8%), SUPRACORE 4 (3%). IT WAS NOTED THAT THE OVERALL COMPLICATION RATE IN THE CURRENT STUDY IS LOW; ALTHOUGH 23 PATIENTS HAD ASYMPTOMATIC POSTPROCEDURE RADIAL OCCLUSION. IN THIS STUDY, THE RIGHT RADIAL ARTERY WAS USED IN ALL CASES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59683 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other