BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3140380 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03412
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ACCULINK STENT WAS IMPLANTED IN A DE NOVO, MODERATELY CALCIFIED, 70% STENOSED, LEFT INTERNAL CAROTID ARTERY, POST-PROCEDURE, THERE WAS HYPOTENSION, SECONDARY TO BARORECEPTOR STRETCHING. DOPAMINE MEDICATION WAS GIVEN. THE PATIENTS HOSPITALIZATION WAS PROLONGED UNTIL THE BLOOD PRESSURE STABILIZED. THIS WAS LISTED AS A SERIOUS EVENT. THE HYPOTENSION RESOLVED WITHOUT AN ADVERSE PATIENT SEQUELA ON (B)(6) 2013 AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241868 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 3021961

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R