BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK 14 STENT SYSTEM

    MDR report key: 1353937 · Received March 31, 2009

    Report

    Report Number
    3004742046-2009-00061
    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. 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. DEVICE #2 - HERCULINK (UNK PART/LOT), REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE #1 MALFUNCTION: NONE. TIME OF SYMPTOMS/AE: 11 MONTHS POST PROCEDURE. SYMPTOMS/AE: IN-STENT RESTENOSIS. THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A RETROSPECTIVE STUDY WAS PERFORMED IN A TOTAL PATIENTS THAT UNDERWENT RENAL TRANSPLANTATION. ONE HUNDRED AND SEVENTEEN PATIENTS UNDERWENT ANGIOGRAPHY FOR PRESUMED RENAL ARTERY STENOSIS. OF THESE, SOME PATIENTS HAD TRANSPLANT RENAL ARTERY STENOSIS. THE PATIENTS WERE TREATED WITH PTA, WITH OR WITHOUT STENT INSERTION OF SURGERY. ONE PATIENT RECEIVED TWO HERCULINK STENTS IN THE SUPERIOR AND INFERIOR RENAL ARTERIES. ELEVEN MONTHS AFTER INITIAL STENT INSERTION, ANGIOGRAPHY REVEALED A 50%-60% IN-STENT STENOSIS IN THE MORE SUPERIOR OF THE TWO ARTERIES. PTA OF THE STENOTIC IN-STENT SEGMENT WAS PERFORMED WITH A GOOD ANGIOGRAPHIC RESULT (<10% RESIDUAL STENOSIS). THE INFERIOR TRANSPLANT ARTERY REMAINED PATENT, ALTHOUGH IT HAD BEEN NOTED AT THE TIME OF INITIAL STENT PLACEMENT THAT THE STENT (DEVICE #2) WAS KINKED IN THE MIDSEGMENT, HAVING FAILED TO EXPAND FULLY WHEN IT WAS DEPLOYED. THIRTY MONTHS AFTER BALLOON ANGIOPLASTY OF THE IN-STENT STENOSIS, ANGIOGRAM DEMONSTRATED 60% STENOSIS IN THE MIDSEGMENT OF THE STENT SITE IN THE INFERIOR RENAL ARTERY. A NON-ABBOTT DRUG ELUTING STENT WAS INSERTED, ALTHOUGH A 10%-20% STENOSIS IN THE MIDSEGMENT PERSISTED.

    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 63 YR Hospitalization| R DEVICE #2 HERCULINK STENT (PART/LOT UNK)