BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 3812968 · Received May 15, 2014

    Report

    Report Number
    2024168-2014-03068
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    March 25, 2013
    Report Date
    May 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 9.0 X 30 X 136 XACT CAROTID STENT MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE INDEX PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE INTERNAL CAROTID ARTERY. DURING DEPLOYMENT OF THE 9.0X40X136 XACT, THE STENT JUMPED FORWARD AND WAS DEPLOYED PARTIALLY IN HEALTHY TISSUE AND PARTIALLY IN THE TARGET LESION. AN UNPLANNED 9.0X30X136 XACT STENT WAS DEPLOYED OVERLAPPING TO TREAT THE REMAINDER OF THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITHOUT ANY ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ON (B)(6) 2014, DURING REGULAR ANGIOGRAPHIC CHECK-UP, IT WAS NOTED THAT THE OVERLAPPING PORTION OF THE TWO DEPLOYED STENTS HAD FRACTURED STRUTS. A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS SUCCESSFULLY ADVANCED; HOWEVER, THE BALLOON RUPTURED DURING INFLATION. AS THE PATIENT IS NON-SYMPTOMATIC AND THE VESSEL IS NOT BLOCKED, THE DECISION WAS MADE TO ABORT FURTHER TREATMENT AND CONTINUE REGULAR MONITORING. THE PROCEDURE WAS COMPLETED WITHOUT ANY ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290761 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R