BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCLUINK 14 STENT SYSTEM

    MDR report key: 1353931 · Received March 31, 2009

    Report

    Report Number
    3004742046-2009-00059
    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: 30 MONTHS POST PROCEDURE. SYMPTOMS/AE: IN-STENT RESTENOSIS. THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS PERFORMED IN 1,189 PATIENTS THAT UNDERWENT RENAL TRANSPLANTATION. ONE HUNDRED AND SEVENTEEN PATIENTS UNDERWENT ANGIOGRAPHY FOR PRESUMED RENAL ARTERY STENOSIS. OF THESE, 53 PATIENTS HAD TRANSPLANT RENAL ARTERY STENOSIS. THE PATIENTS WERE TREATED WITH PTA, WITH OR WITHOUT STENT INSERTION OR SURGERY. ONE OF THE PATIENTS WAS IMPLANTED WITH THE HERCULINK STENT AFTER WHICH NO RESIDUAL STENOSIS WAS OBSERVED. THIRTY MONTHS AFTER STENT INSERTION, THE PATIENT'S BLOOD PRESSURE INCREASED TO 170/100 AND A RENAL ANGIOGRAM DEMONSTRATED 80%-90% IN-STENT STENOSIS. THE PATIENT UNDERWENT REPEAT PTA. AFTER BALLOON DILATION, THERE WAS 10%-20% RESIDUAL STENOSIS. THE PATIENT'S BLOOD PRESSURE REMAINED INCREASED AT 160/100. THE PATIENT WAS RECALLED FOR FURTHER ANGIOPLASTY AND PLACEMENT OF A NON-ABBOTT DRUG ELUTING STENT, LEADING TO RESOLUTION OF THE STENOSIS AND IMPROVEMENT OF BLOOD PRESSURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R