BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2033037 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02140
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 26, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT (STROKE) AND ISCHEMIA ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE 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.

    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. NEUROLOGICAL DEFICIT/DYSFUNCTION AND SEIZURE ARE LISTED IN THE PRODUCT INSTRUCTIONS FOR USE 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 EIGHT DAYS AFTER THE ACCULINK STENT WAS IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT WAS RE-ADMITTED FOR A FALL, LEFT-SIDED WEAKNESS, AND A PROBABLE SEIZURE. THE CT SCAN OF THE BRAIN, CTA OF THE BRAIN AND NECK, MRI OF THE BRAIN, AND MRA OF THE BRAIN WERE ALL NEGATIVE FOR A STROKE. THERE WERE NO OTHER SYMPTOMS. THE PATIENT REQUIRED BRONCHODILATORS, INTRAVENOUS STEROIDS, HEPARIN, AND VENTILATOR SUPPORT. THE PATIENT WAS DISCHARGED FOUR DAYS AFTER ADMISSION AND THE EVENT RESOLVED. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INTIAL MEDWATCH FILED, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS DISCHARGED WITH A DIAGNOSIS OF A MILD CEREBROVASCULAR ACCIDENT WITH MULTIPLE, SMALL, ISCHEMIC EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0100461

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R