BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2112075 · Received June 2, 2011

    Report

    Report Number
    2024168-2011-03852
    Event Type
    Death
    Date Received
    June 2, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF HEMORRHAGE, NEUROLOGICAL DEFICIT/DYSFUNCTION, TRANSIENT ISCHEMIC ATTACK (TIA) AND DEATH ARE LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU) AS KNOWN POTENTIAL ADVERSE EFFECTS. 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 PATIENT UNDERWENT A PROCEDURE INVOLVING THE RIGHT INTERNAL CAROTID ARTERY WHICH WAS 90% STENOSED ON (B)(6), 2011. THE PROCEDURE TOOK PLACE AROUND 11:00 A.M. WHERE UPON A XACT STENT WAS IMPLANTED. DURING THE PROCEDURE, THE PATIENT DEVELOPED TRANSIENT ISCHEMIC ATTACK SYMPTOMS; HOWEVER, ONE HOUR LATER THE SYMPTOMS HAD RESOLVED AND EVERYTHING LOOKED GOOD ON THE FILMS. AROUND 4:00 P.M. THE PHYSICIAN CHECKED ON THE PATIENT AND THE PATIENT WAS DOING FINE. HOWEVER, AROUND 5:00 P.M. THE PATIENT STARTED DECLINING AND A CT SCAN WAS DONE WHICH IDENTIFIED A 9 CM BLEED IN THE BRAIN REPORTEDLY DUE TO HYPERPERFUSION SYNDROME. SURGERY WAS PLANNED BUT THE PATIENT DIED BEFORE THEY COULD BE TAKEN TO SURGERY. THE PATIENT DIED ABOUT AN HOUR AFTER THE CT SCAN NOTED THE BLEEDING IN THE BRAIN. THE PATIENT WAS NOT ENROLLED IN A STUDY BUT WAS CONSIDERED A HIGH RISK PATIENT. 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-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death