BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1923383 · Received December 13, 2010

    Report

    Report Number
    3004742046-2010-00605
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. EMBOLIC PROTECTION: EMBOSHIELD NAV 6 (CATALOGUE 22438-19, LOT 0091051). THE STENT REMAINS IN THE PATIENT. THE DELIVERY SYSTEM WAS DISCARDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF HYPOTENSION, IS LISTED IN THE XACT INSTRUCTIONS FOR USE AS A KNOWN ADVERSE PATIENT EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND TREATMENT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, LABELING AND DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE".

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT AFTER POST DILATATION OF THE XACT STENT IN THE LEFT INTERNAL CAROTID ARTERY BIFURCATION, THE PATIENT EXPERIENCED HYPOTENSION. THE PATIENT WAS GIVEN A DOPAMINE INFUSION FOR ONE DAY, AND THE PATIENT'S BLOOD PRESSURE MEDICATIONS WERE HELD. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY WITH ORAL MEDICATION TO INCREASE BLOOD PRESSURE (PSEUDOPHED). THE PATIENT'S HYPOTENSION IS CONTINUING BUT IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-VS 0082061

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention CONCOMITANT MEDICAL DEVICES.