BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1051750 · Received May 23, 2008

    Report

    Report Number
    3004742046-2008-00117
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    September 25, 2007
    Report Date
    January 4, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K021824
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: MICHAEL KELLEY, MD AND GREGORY MISHKEL MD; "SUCCESSFUL COMPLES BIFURCATION STENTING OF A NATIVE SFA AFTER FAILED FEMOROPOPLITEAL BYPASS GRAFTING: CATHERIZATION AND CARDIOVASCULAR INTERVENTIONS 2007; 70:602-609. THIS REPORT INVOLVES CASE REPORT NOTED IN AN ARTICLE. NO DEVICE WAS AVAILABLE FOR ANALYSIS. THE PART AND LOT NUMBER WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD COULD NOT BE PERFORMED. RESTENOSIS IS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF STENTS, REFERENCED IN THE DEVICE INSTRUCTIONS FOR USE (IFU). THE ABSOLUTE IS INDICATED IN THE IFU FOR BILIARY USE. THE ABSOLUTE PART# UNK, LOT#UNK, REFERENCED IS BEING FILED UNDER THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    SYMPTOMS/AE: IN-STENT RESTENOSIS. TIME OF SYMPTOMS/AE: EIGHT MONTHS AFTER IMPLANTATION. THE FOLLOWING WAS NOTED DURING ARTICLE REVIEW. AN OCCLUSION OF A LEFT FEMOROPOPLITEAL BYPASS GRAFTING WAS OBSERVED BY ANGIOGRAPHY IN A PT WITH RECURRENT CLAUDICATION TWO MONTHS POST BYPASS PLACEMENT. THROMBECTOMY AND PULSED THROMBOLYTIC THERAPY OF THE GRAFT WAS PERFORMED FOLLOWED BY STENTING WITH 8MM ABSOLUTE STENTS. THE PROXIMAL STENT WAS DEPLOYED IN THE NATIVE LEFT COMMON FEMORAL ARTERY (LCFA) AND PROXIMAL BYPASS GRAFT, ACROSS THE ORIGIN OF THE PROFUNDA ARTERY. THE SECOND ABSOLUTE WAS IMPLANTED IN THE DISTAL BYPASS GRAFT EXTENDED INTO THE NATIVE LEFT POPLITEAL ARTERY UNEVENTFULLY. EIGHT MONTHS LATER, THE PT PRESENTED WITH PROGRESSIVE CLAUDICATION SYMPTOMS AND A CT ANGIOGRAM DEMONSTRATED REOCCLUSION OF THE RECENTLY STENTED BYPASS GRAFT. THE STENT IN THE LCFA HAD JAILED THE PROFUNDA ARTERY; HOWEVER, IT WAS PATENT. THE PT WAS READMITTED TO PERFORM A COMPLEX BIFURCATION ANGIOPLASTY AND STENTING. THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) WAS PRE-DILATED. THE PROXIMAL SFA WAS FURTHER DILATED AND STENTED WITH A NON-ABBOTT STENT FORMING A Y-STENT CONFIGURATION INSIDE THE ORIGINAL ABSOLUTE STENT IN THE LCFA AND PROXIMAL BYPASS GRAFT. THE POPLITEAL ARTERY, AT THE SITE OF PRIOR GRAFT IMPLANTATION, WAS ALSO TREATED WITH A NON-ABBOTT STENT, FORMING A Y-STENT CONFIGURATION INSIDE THE PREVIOUSLY IMPLANTED ABSOLUTE STENT IN THE DISTAL BYPASS GRAFT AND NATIVE LEFT POPLITEAL ARTERY. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AND HAS NOT SHOWN CLAUDICATION SYMPTOMS OVER ONE YEAR POST-PROCEDURE. THE STENTS REMAIN PATENT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM 78FGE FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R ABSOLUTE 8MM STENT