BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1980757 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00733
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    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. DIL CATH: VIATRAC 14 PLUS, 5.0 X 20 MM, REF 1008193-20, LOT 0100751. OTHER: HEPARIN. EMBOLIC PROTECTION: RX ACCUNET (1011649-55, LOT # 0082461). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF HYPOTENSION IS LISTED IN THE PRODUCT INSTRUCTION FOR USE AS KNOWN POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 VIA A TRIAL THAT DURING A RIGHT INTERNAL CAROTID RX ACCULINK STENTING PROCEDURE, DURING POST DILATATION WITH A VIATRAC BALLOON, THE PATIENT EXPERIENCED HYPOTENSION WHICH WAS TREATED WITH MIDODRINE AND IV FLUIDS. THE PATIENT'S CONDITION IS CONTINUING BUT IMPROVED. THE PATIENT WAS DISCHARGED HOME ONE DAY AFTER THE PROCEDURE ON ANTI-HYPOTENSIVE MEDICATION. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 0100561

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention