BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1955374 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00206
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF CEREBROVASCULAR ACCIDENT IS A KNOWN ADVERSE EVENTS LISTED IN THE RX XACT INSTRUCTIONS FOR USE. 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.

    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 BRADYCARDIA, HYPOTENSION, AND RESPIRATORY FAILURE ARE KNOWN ADVERSE EVENTS LISTED IN THE RX XACT INSTRUCTIONS FOR USE. ADDITIONALLY, BRADYCARDIA, HYPOTENSION, RESPIRATORY FAILURE RESULTING IN INTUBATION, AND NON-SURGICAL TREATMENT WITH MEDICATION ARE LISTED IN THE NO FAULT RISK ASSESSMENT AS NO FAULT COMPLICATIONS. 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

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT EXPERIENCED A STROKE. IT CANNOT BE DETERMINED IF THE STROKE OCCURRED PRIOR TO HIS HOSPITALIZATION OR SOMETIME DURING THE HOSPITALIZATION. CT OF THE HEAD ON (B)(6) 2010 SHOWED FOCAL AREA OF HYPODENSITY ADJACENT TO THE LEFT HEMISPHERE CENTRAL SULCUS WHICH IS NEW FROM PREVIOUS EXAM. SUSPICIOUS THAT THIS REPRESENTS A SUBACUTE CORTICAL INFARCT. THE PATIENT'S ASPIRIN AND PLAVIX WERE CONTINUED. THE PATIENT'S CONDITION WAS AT HIS BASELINE AT THE 30 DAY FOLLOW-UP OFFICE VISIT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER POST XACT STENT DEPLOYMENT IN THE LEFT INTERNAL CAROTID AND COMMON CAROTID ARTERY BIFURCATION, THE PATIENT EXPERIENCED HYPOTENSION, BRADYCARDIA AND RESPIRATORY DISTRESS. THE PATIENT WAS TREATED WITH ATROPINE, DOPAMINE, LEVOPHED, MIDODRINE AND INTUBATION. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED SIX DAYS AFTER THE PROCEDURE TO A REHABILITATION FACILITY. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, 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 0091561

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R| S EMBOSHIELD NAV6HEPARIN