BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK 14 STENT SYSTEM

    MDR report key: 1344919 · Received March 16, 2009

    Report

    Report Number
    3004742046-2009-00049
    Event Type
    Injury
    Date Received
    March 16, 2009
    Date of Event
    November 1, 2008
    Report Date
    February 25, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K053459
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (OFF-LABEL USE IN THE VASCULATURE); (STENT FOLDED ON ITSELF). THIS REPORT INVOLVES A RETROSPECTIVE STUDY NOTED IN THE 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. THE REPORTED DEVICE ISSUE APPEARS TO BE PROCEDURAL RELATED WHICH CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, DEVICE REMOVAL TECHNIQUE, GUIDING CATHETER SUPPORT, PT ANATOMICAL MORPHOLOGY, AND PT DISEASE STATE. ATTACHMENT: SANJAY MISRA, MD, ET AL; "EMBOLIC PROTECTION DEVICES IN PATIENTS WITH RENAL ARTERY STENOSIS WITH CHRONIC RENAL INSUFFICIENCY: A CLINICAL STUDY", PUBLISHED J VASC INTERV RADIOL 2008; 19: 1639-1645.

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT FOLDED. TIME OF SYMPTOMS/AE: DURING PROCEDURE. SYMPTOMS/AE: DECLINE IN KIDNEY FUNCTION. THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A RETROSPECTIVE STUDY WAS CONDUCTED IN A TOTAL PATIENTS FROM 2005 TO 2006. THE PURPOSE OF THE STUDY WAS TO PRESENT CLINICAL OUTCOMES WITH THE USE OF EMBOLIC PROTECTION DEVICES (EPDS) AND RENAL ARTERY STENTS IN PATIENTS WITH CHRONIC RENAL INSUFFICIENCY (CRI) AND RENAL ARTERY STENOSIS (RAS). THE AVERAGE FOLLOW-UP WAS 8 MONTHS. COMPLICATIONS INCLUDED: IN ONE PT, THE NON-ABBOTT EMBOLIC PROTECTION DEVICE COULD NOT BE CAPTURED AFTER SUCCESSFULLY DEPLOYING THE STENT. THIS RESULTED IN THE EPD CAUSING THE DISTAL ASPECT OF THE STENT TO FOLD UPON ITSELF. THE FOLLOWING DAY, BALLOON ANGIOPLASTY WAS PERFORMED TO SUCCESSFULLY DILATE THE STENT. FOLLOW-UP ANGIOGRAM REVEALED GOOD FLOW OF CONTRAST MEDIUM ACROSS THE STENT WITH NO DISTAL EMBOLIZATION. ADDITIONALLY, ONE PT HAD A DECLINE IN KIDNEY FUNCTION AFTER RENAL ARTERY STENT PLACEMENT. THERE IS NO DIRECT CORRELATION BETWEEN THE ADVERSE EVENTS AND THE DEVICE/BRAND/MANUFACTURER.

    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 69.4 YR Required Intervention BALLOON CATH: POWERSAIL| FILTER WIRE EZ| CYPHER CORONARY, EXPRESS BILIARY| EPD: SPIDE RX| GUIDE CATH: SIMMONS 1| GUIDE WIRE: .014" REFLEX WIRE| STENTS: PALMAZ BLUE, TAXUS EXPRESS2 MONORAIL