BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1936307 · Received December 22, 2010

    Report

    Report Number
    3004742046-2010-00619
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 4, 2010
    Report Date
    December 4, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. EMBOSHIELD NAV 6 ((B)(4)), HEPARIN. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS IDENTIFIED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF TRANSIENT ISCHEMIC ATTACK (TIA), AS LISTED IN THE XACT INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT. ADDITIONALLY, TRANSIENT ISCHEMIC ATTACK AND TREATMENT WITH MEDICATION(S) ARE ADDRESSED IN THE PRODUCT RISK ASSESSMENT, AS POTENTIAL NO-FAULT COMPLICATIONS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE AND DESIGN.

    Description of Event or Problem · 1

    IN USING AN AFFECTED TEST STRIP RELATED TO AN ON-GOING FIELD ACTION FOR ABBOTT'S PRECISION FAMILY TEST STRIPS, THE CUSTOMER REPORTED EITHER LONGER BLOOD FILL TIME OR READINGS ISSUES. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST STENT IMPLANTATION IN THE UNSPECIFIED CAROTID ARTERY THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK WITH EXPRESSIVE APHASIA, PROLONGING HOSPITALIZATION. PLAVIX WAS GIVEN AND THE SYMPTOMS COMPLETELY RESOLVED THAT AFTERNOON. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-VS 0080461

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R