BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 2091491 · Received May 17, 2011

    Report

    Report Number
    2024168-2011-03516
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K052166
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT (STROKE) AND WEAKNESS ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS 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 DURING A LEFT INTERNAL CAROTID STENTING PROCEDURE AFTER THE RX ACCUNET EMBOLIC PROTECTION DEVICE CROSSED THE TARGET LESION, THE PATIENT EXPERIENCED A STROKE WITH RIGHT SIDED WEAKNESS AND GLOBAL APHASIA. TREATMENT INCLUDED EPTIFIBATIDE INFUSION. THE WEAKNESS RESOLVED AT THE END OF THE PROCEDURE AND THE APHASIA IS GREATLY IMPROVED AT POST PROCEDURE DAY TWO. THE PATIENT'S CONDITION RESOLVED TO BASELINE AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011. THOUGH REQUESTED 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 1010461

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S STENT: RX ACCULINK