BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK 14 STENT SYSTEM

    MDR report key: 2080859 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03275
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    February 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K063481
    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. BILIARY STENT USED OUTSIDE OF THE BILIARY TREE. DATE OF OCCURRENCE ESTIMATED AS (B)(6) 2011. THERE WAS NO REPORTED PRODUCT DEFICIENCY. 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. PER THE HERCULINK INSTRUCTIONS FOR USE (IFU), THE HERCULINK STENT SYSTEM IS INTENDED TO TREAT MALIGNANT STRICTURES IN THE BILIARY TREE. TWO UNKNOWN HERCULINK STENT SYSTEMS WERE USED OUTSIDE OF THE BILIARY TREE, WHICH ARE NOT INDICATED SITES FOR THIS DEVICE. THERE IS NO INDICATION THAT THIS USE LED TO THE REPORTED PATIENT EFFECTS OF NAUSEA AND HYPERSENSITIVITY. THE PROMUS STENT IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2 WEEKS POST IMPLANTATION OF 2 HERCULINK STENTS AND 1 PROMUS STENT IN THE SUPERIOR MESENTERIC, CELIAC AND INFERIOR MESENTERIC ARTERIES, THE PATIENT EXPERIENCED NAUSEA AND A RASH. ON (B)(6) 2011, THE PATIENT WAS SEEN BY THEIR PHYSICIAN. PLAVIX WAS DISCONTINUED. THE PATIENT WILL BE TESTED FOR ALLERGIES TO BOTH STENTS. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX HERCULINK 14 STENT SYSTEM BILIARY STENT SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other STENTS: PROMUS, HERCULINKPLAVIX, ASPIRIN