BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK 14 STENT SYSTEM

    MDR report key: 1353936 · Received March 31, 2009

    Report

    Report Number
    3004742046-2009-00060
    Event Type
    Injury
    Date Received
    March 31, 2009
    Date of Event
    September 9, 2008
    Report Date
    March 16, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K053459
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A RETROSPECTIVE STUDY NOTED IN AN ARTICLE. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS AND DEVICE INVESTIGATION COULD NOT BE PERFORMED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. ATTACHMENT: PETER RILEY, MBCHB, ET AL; "DRUG-ELUTING STENT INSERTION IN THE TREATMENT OF IN-STENT RENAL ARTERY RESTENOSIS IN THREE RENAL TRANSPLANT RECIPIENTS", PUBLISHED J VASC INTERV RADIOL 2008; 19:1757-1760.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE: TIME OF SYMPTOMS/AE: 5 MONTHS POST PROCEDURE. SYMPTOMS/AE: IN-STENT RESTENOSIS. THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A RETROSPECTIVE STUDY WAS PERFORMED IN ALL PATIENTS THAT UNDERWENT RENAL TRANSPLANTATION. ONE HUNDRED AND SEVENTEEN PATIENTS UNDERWENT ANGIOGRAPHY FOR PRESUMED RENAL ARTERY STENOSIS. OF THESE, A TOTAL PATIENTS HAD TRANSPLANT RENAL ARTERY STENOSIS. THE PATIENTS WERE TREATED WITH PTA, WITH OR WITHOUT STENT INSERTION OF SURGERY. ONE PATIENT WAS IMPLANTED WITH THE HERCULINK STENT FOR OSTEAL STENOSIS OF 60% AFTER INITIAL ANGIOPLASTY, LEADING TO MARKED REDUCTION OF THE STENOSIS TO NO GREATER THAN 10%. FIVE MONTHS LATER, THE PATIENT WAS READMITTED WITH WORSENING HYPERTENSION, ALTHOUGH RENAL FUNCTION REMAINED STABLE. REPEAT ANGIOGRAM DEMONSTRATED CURRENT OSTEAL STENOSIS APPROXIMATELY 70%-80% IN DIAMETER. A NON-ABBOTT DRUG-ELUTING STENT WAS SUCCESSFULLY PLACED WITHIN THE STENOSED SEGMENT AND BLOOD PRESSURE IMPROVED.

    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 74 YR Hospitalization| R