BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1812629 · Received August 17, 2010

    Report

    Report Number
    3004742046-2010-00366
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 23, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). RESTENOSIS OF THE STENTED ARTERY MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, IS A KNOWN POTENTIAL ADVERSE PATIENT EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. INFORMATION AVAILABLE IN THE CASE DESCRIPTION IS NOT SUFFICIENT TO DETERMINE A RELATIONSHIP BETWEEN THE EVENT AND THE ABBOTT VASCULAR PRODUCT. BASED ON AVAILABLE INFORMATION , A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    DURING THE F/U DATED (B)(6) 2010, THE PHYSICIAN OBSERVED THAT SOME NOISE EPISODES WERE RECORDED IN THE HOLTER MEMORY; IN ADDITION, IN TWO OCCASIONS, THIS LED TO INAPPROPRIATE SHOCK THERAPIES. THE PHYSICIANS REQUESTED AN ANALYSIS OF THE PATIENT FILES.

    Description of Event or Problem · 1

    DEVISE ISSUE: NONE. ADVERSE EVENT: SUBACUTE RESTENOSIS. ONSET OF ADVERSE EVENT: 1 DAY AFTER THE PROCEDURE. IT WAS REPORTED THAT THE DAY FOLLOWING THE SUCCESSFUL IMPLANTATION OF THE XACT STENT IN THE LEFT INTERNAL CAROTID ARTERY, A ROUTINE DUPLEX STUDY SHOWED A POSSIBLE STENT OCCLUSION THAT WAS CONFIRMED BY CT SCAN. THE CT SCAN DID NOT SHOW ANY EVIDENCE OF A STROKE AND THE PATIENT'S NEUROLOGICAL STATUS REMAINED INTACT. THE PATIENT HAD FAILED TO TAKE CLOPIDOGREL THE WEEK PRIOR TO THE PROCEDURE AS RECOMMENDED BY THE PHYSICIAN. THERE WAS NO REPORTED INTERVENTION. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. THERE WAS NO ADVERSE PATIENT EFFECTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 0031061

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other EMBOLIC PROTECTION: EMBOSHIELD NAV6, (B)(4),| HEPARIN| LOT 0050751