BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1914524 · Received December 3, 2010

    Report

    Report Number
    3004742046-2010-00574
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 ISCHEMIA AND DISSECTION ARE LISTED AS A POTENTIAL ADVERSE EVENTS IN THE PRODUCT INSTRUCTION FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE SECOND XACT STENT (PART 82095-01) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED FOR TREATMENT OF RESTENOSIS OF THE RIGHT INTERNAL/COMMON CAROTID ARTERY POST ENDARTERECTOMY. DURING THE PROCEDURE, AN EMBOSHIELD NAV6 FILTER ELEMENT WAS PLACED DISTALLY PAST THE LESION WITHOUT ANY ISSUES. THE XACT 9 X 40 X 136 STENT WAS DEPLOYED AND POST DILATATION WAS DONE WITH A 5.0 X 20 NON ABBOTT BALLOON CATHETER. FLUOROSCOPY WAS DONE AND NO FLOW WAS NOTED DISTAL TO THE XACT AND AT CLOSER LOOK A DISSECTION WAS OBSERVED AT THE DISTAL EDGE OF THE XACT STENT. THE DISSECTION WAS TREATED WITH AN ADDITION XACT 7 X 20 X 136; HOWEVER, AFTER DEPLOYMENT OF THIS STENT, IT CAUSED THE DISSECTION TO CONTINUE MORE DISTALLY. A CORONARY NON ABBOTT STENT 4.5 X 24 WAS USED TO TREAT THE DISSECTION AND WAS SUCCESSFUL IN CONTAINING THE DISSECTION. BLOOD FLOW WAS FOUND TO BE GOOD, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED UPON REMOVAL OF THE NAV 6 FILTER ELEMENT. THE PATIENT WAS FINE AFTER THE PROCEDURE AND WAS DISCHARGED ON (B)(6) 2010. THOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE PHYSICIAN COMMENTED THAT THE FACT THAT THE PATIENT HAD ENDARTERECTOMY SURGERY ONE YEAR AGO HAD A LOT TO DUE WITH THE DISSECTION THAT OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention XACT STENT (82095-01),EMBOSHIELD NAV6 EPD