BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1830922 · Received September 7, 2010

    Report

    Report Number
    3004742046-2010-00403
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 14, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE PRODUCT USED DURING THE PROCEDURE WAS NOT RETURNED WHICH COULD HAVE AIDED IN THE DETERMINATION OF THE CAUSE; HOWEVER, INACCURATE DELIVERY MAY BE A RESULT OF, BUT NOT LIMITED TO, PT'S VESSEL GEOMETRY OR THE VESSEL DIAMETER WHICH COULD HAVE BEEN LARGER THAN THE STENT OR WHEN THE STENT DOES NOT APPOSE THE VESSEL WALL WHEN THE STENT IS FULLY DEPLOYED, AND THE POSITIONING OF THE STENT PRIOR TO DEPLOYMENT WAS NOT OPTIMAL. A CONCLUSIVE CAUSE FOR THE REPORTED EVENT APPEARS TO BE DUE TO PT MOVEMENT AND A HEAVILY CALCIFIED VESSEL AND NOT A MFG PRODUCT DEFICIENCY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS REPORT. ALL CATHETERS ARE INSPECTED DURING THE FINAL INSPECTION TO ENSURE THE PRODUCT STRUCTURE AND INTEGRITY. IN ADDITION, SAMPLES FROM EACH LOT ARE VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED.

    Description of Event or Problem · 1

    DEVICE ISSUE: INACCURATE STENT DELIVERY. TIME OF DEVICE ISSUE: DURING STENT PLACEMENT. ADVERSE EVENT (AE): STENT NOT FULLY COVERING THE LESION RESULTING IN PLACEMENT OF A SECOND UNPLANNED STENT. ONSET OF AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE IN A HEAVILY CALCIFIED LESION, DURING STENT PLACEMENT, THE XACT STENT WAS PLACED SLIGHTLY DISTAL TO THE LESION, REQUIRING THE PLACEMENT OF A SECOND UNPLANNED STENT. REPORTEDLY, THE PHYSICIAN FELT THE INACCURATE PLACEMENT WAS DUE TO A COMBINATION OF THE PT MOVING AND THE HEAVY CALCIFIED CAROTID ARTERY. THERE WAS NO ADVERSE PT SEQUELA REPORTED. ONE DAY POST-PROCEDURE, THE PT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0031261

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 22438-19, LOT NUMBER 0052751| EMBOLIC PROTECTION: EMBOSHIELD NAV 6