BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2770723 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06234
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 6, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 WERE NO REPORTED PRODUCT DEFIENCIES. THE REPORTED PATIENT EFFECT OF HYPOTENSION IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT 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 THE PATIENT UNDERWENT A STENTING PROCEDURE ON (B)(6) 2012 WITH PLACEMENT OF A 6-8 X 40 MM ACCULINK STENT IN THE HEAVILY CALCIFIED LEFT INTERNAL CAROTID ARTERY. POST PROCEDURE, THE PATIENT EXPERIENCED AN EPISODE OF HYPOTENSION. MEDICATION WAS PROVIDED AND THE HYPOTENSION RESOLVED ON (B)(6) 2012. 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 2051061

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R EMBOLIC PROTECTION: RX ACCUNET