BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 2133663 · Received June 20, 2011

    Report

    Report Number
    2024168-2011-04338
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K081549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 VIATRAC IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. CEREBROVASCULAR ACCIDENT (STROKE), EMBOLISM AND TIA 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 AFTER PREDILATATION IN THE LEFT INTERNAL CAROTID ARTERY USING THE VIATRAC BALLOON, THE PATIENT EXPERIENCED A DISSECTION AND COMPROMISED FLOW THAT PROMPTLY RESOLVED AFTER THE ACCULINK STENT WAS DEPLOYED. THE RX ACCUNET WAS IN THE PATIENT VASCULATURE AT THE TIME OF THE DISSECTION. THE ACCULINK SEALED THE DISSECTION AND TREATED THE COMPROMISED FLOW. AFTER THE PROCEDURE, THE PATIENT HAD APHASIA, SLURRING OF WORDS, PARTIAL PARALYSIS, RIGHT FACIAL DROOP, AND RIGHT ARM DRIFT THAT WAS INITIALLY DIAGNOSED AS A TRANSIENT ISCHEMIC ATTACK (TIA). THE PATIENT WAS GIVEN HEPARIN; HOWEVER, THE PATIENT'S CONDITION REMAINS UNCHANGED. AN MRI THE FOLLOWING DAY SUGGESTED ACUTE INFARCTS QUESTIONABLE OF AN EMBOLIC EVENT. THE EVENT WAS THEN CLASSIFIED AS A STROKE. THE PATIENT WAS DISCHARGED HOME FIVE DAYS AFTER THE PROCEDURE WITH CONTINUING SYMPTOMS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 1020961

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention| S STENT: RX ACCULINK ((B)(4))