BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2831901 · Received November 14, 2012

    Report

    Report Number
    2024168-2012-07182
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)94). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(6) 2012: COMPUTED TOMOGRAPHY= SMALL LEFT PARIETAL LOBE INFARCT AND DEEP WHITE MATTER INFARCT IN THE RIGHT TEMPORAL LOBE. (B)(6) 2012: MAGNETIC RESONANCE IMAGING= SMALL LEFT PARIETAL LOBE INFARCT AND DEEP WHITE MATTER INFARCT IN THE RIGHT TEMPORAL LOBE. (B)(6) 2012: CAROTID DOPPLER ULTRASOUND=PATENT STENT. ADD'L DEVICES: OTHER: ASPIRIN, CLOPIDOGREL; EMBOLIC PROTECTION: RX ACCUNET. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT AND NEUROLOGICAL DEFICIT DYSFUNCTION ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A STENTING PROCEDURE IN THE MILDLY CALCIFIED LEFT INTERNAL CAROTID ARTERY. AN RX ACCUNET WAS ADVANCED TO THE TARGET SITE AND DEPLOYED. A 7-10 X 30 MM RX ACCULINK STENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE TARGET LESION AND DEPLOYED. THE PATIENT WAS DISCHARGED TO HOME TWO DAYS POST PROCEDURE. ON (B)(6) 2012, THE PATIENT WAS FOUND ON HER BEDROOM FLOOR, UNRESPONSIVE. THE PATIENT WAS RE-HOSPITALIZED AND EXPERIENCED ALTERED MENTAL STATUS. COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING REVEALED A SMALL LEFT PARIETAL LOBE INFARCT AND DEEP WHITE MATTER INFARCT IN THE RIGHT TEMPORAL LOBE AND A CEREBROVASCULAR ACCIDENT (CVA) WAS DIAGNOSED. DOPPLER ULTRASOUND NOTED THE STENT IN THE LEFT INTERNAL CAROTID ARTERY WAS PATENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2012; HOWEVER, THE CONDITION CONTINUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2022461

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| S