BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2914150 · Received January 14, 2013

    Report

    Report Number
    2024168-2013-00278
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 20, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIL CATH: VIATRAC 4X20X135; GUIDE WIRE: .014 X 180 ASAHI PROWATER GW; EMBOLIC PROTECTION DEVICE: 6MM SPIDER FX; SHEATH: 6F SHEATH. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE REPORTED THROMBOSIS IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE XACT CAROTID STENT SYSTEM INSTRUCTIONS FOR USE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE RX ACCULINK, REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A 95% STENOSED, HEAVILY CALCIFIED, LEFT, INTERNAL CAROTID ARTERY STENTING PROCEDURE, AFTER PRE-DILATATION, A XACT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT WOULD NOT CROSS THE LESION DUE TO THE VESSEL TORTUOUSITY. ANOTHER NON-ABBOTT SDS WAS ADVANCED, BUT WOULD NOT CROSS EITHER. AN ACCULINK SDS SUCCESSFULLY CROSSED TO COMPLETE THE STENTING PROCEDURE AND A NON-ABBOTT CATHETER WAS USED TO EXTRACT A THROMBUS THAT WAS FOUND IN THE FILTER POST STENTING. ALTHOUGH THE THROMBUS WAS REPORTEDLY CAUSED BY THE NON-ABBOTT CAROTID SDS, IT'S UNCLEAR WHEN THE THROMBUS ACTUALLY OCCURRED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21580 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2052161

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention CONCOMITANT MEDICAL DEVICES