BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2141652 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04497
    Event Type
    Death
    Date Received
    June 27, 2011
    Date of Event
    May 29, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 EFFECTS OF CEREBROVASCULAR ACCIDENT (STROKE), HEMORRHAGE AND DEATH ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE USE OF THE PRODUCT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCULINK STENT WAS UNABLE TO CROSS THE CALCIFIED AREA OF THE TARGET LESION IN THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS PREDILATED, BUT THE ACCULINK WAS STILL UNABLE TO CROSS THE LESION. AN XACT STENT WAS ABLE TO CROSS AND WAS IMPLANTED WITHOUT FURTHER INCIDENT. SEVENTEEN DAYS AFTER THE CAROTID STENTING PROCEDURE, THE PATIENT EXPERIENCED AN INTRACEREBRAL HEMORRHAGE. THE PATIENT UNDERWENT A RIGHT FRONTO-TEMPORA-PARIETAL CRANIOTOMY, PLATELET TRANSFUSIONS, FRESH FROZEN PLASMA TRANSFUSIONS AND RECEIVED FACTOR 7. DESPITE THESE TREATMENTS, THERE WAS NO SIGNIFICANT IMPROVEMENT AND THE PATIENT EXPIRED 3 DAYS AFTER THE HEMORRHAGE. 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 AV-TEMECULA-CT 0011551

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death