BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX HERCULINK 14 STENT SYSTEM

    MDR report key: 1840841 · Received September 17, 2010

    Report

    Report Number
    3004742046-2010-00425
    Event Type
    Death
    Date Received
    September 17, 2010
    Date of Event
    March 6, 2008
    Report Date
    August 31, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 MANUFACTURER, OR DESIGN. EG.: PP JOKHI, K RAMANATHAN, S WALSH, ET AL; "EXPERIENCE OF STENTING FOR ATHEROSCLEROTIC RENAL ARTERY STENOSIS IN A CARDIAC CATHETERIZATION LABORATORY: TECHNICAL CONSIDERATIONS AND COMPLICATIONS." CAN J CARDIOL VOL 25 NO 8 AUGUST 2009. THE UNK MULTI-LINK RX ULTRA, AND UNK MULTI-LINK RX TETRA, INDICATED ARE BEING FILED UNDER SEPARATE MFR#'S.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED DURING LITERATURE REVIEW: A PROSPECTIVE STUDY WAS PERFORMED IN 106 PATIENTS IN REVIEW. ONE HUNDRED SIX PATIENTS UNDERWENT RENAL ARTERY STENTING. OF THOSE 106 PATIENTS AT APPROXIMATELY 6 WEEKS AND 10 MONTHS, TWO PATIENTS DIED REPORTED TO BE FROM RENAL FAILURE AND CARDIAC CAUSES. OF THOSE 106 PATIENTS 6 PATIENTS SUFFERED FROM RENAL DEFICIENCY AND HIGH CREATINE LEVELS, 1 PATIENT SUFFERED A DISSECTION AND 2 PATIENTS UNDERWENT REVASCULARIZATION FOR PLANNED CABG PROCEDURES. ONE PATIENT UNDERWENT REVASCULARIZATION OF THE RENAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX HERCULINK 14 STENT SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death UNK MULTI-LINK RX ULTRA| GUIDE WIRE: FILTERWIRE EZ| GENESIS| RACER| STENT: EXPRESS| ANGIOGUARD| LIBERTE| UNK MULTI-LINK RX TETRA