BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 1151373 · Received May 22, 2008

    Report

    Report Number
    9610978-2008-00132
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 30, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    k012590
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE REPORT INDICATED THAT THE PT WAS ADMITTED FOR TREATMENT OF LEFT LEG CLAUDICATION. A 5FRENCH SHEATH WAS PLACED IN THE RIGHT FEMORAL ARTERY. ABDOMINAL ANGIOGRAM WAS PERFORMED WITH AN OMNIFLUSH CATHETER PLACED ABOVE THE RENALS. UNDER FLUOROSCOPIC GUIDANCE AFTER ABDOMINAL AORTOGRAMS, RUNOFFS WERE PERFORMED. THE ABDOMINAL ANGIOGRAM SHOWED MILD ANEURISMAL DILATION OF THE DISTAL AORTA WITH WELL FUNCTIONING STENT IN THE LEFT RENAL. THE ILIACS SHOWED SIGNIFICANT DISEASE PROXIMAL LEFT WITH PLAQUING IN THE RIGHT AND 80% STENOSIS OF THE LEFT. THE PROD WAS NOT RETURNED FOR ANALYSIS ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    AFTER REVIEW OF THE FILMS, A 7FRENCH DESTINATION SHEATH WAS PLACED TO THE BIFURCATION. AN 8 X 29 MM GENESIS TRANSHEPATIC BILIARY STENT WAS ATTEMPTED TO PLACE ACROSS THE LESION, BUT IT DOES NOT MOVE, AND DURING WITHDRAWAL THROUGH THE GUIDE, THE STENT DISLODGE FROM THE BALLOON. AFTER INSERTING A 6FRENCH SHEATH THROUGH THE LEFT SIDE, MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE WITH A SNARE DEVICE, BUT THE ATTEMPTS FAILED. THE STENT WAS OVER A GUIDEWIRE VISUALIZED IN THE RIGHT ILIAC. THE PT WAS SENT TO THE OPERATING ROOM FOR REMOVAL. THE PT WAS ALERT, AWAKE AND ORIENTED. THE OPERATING REPORT INDICATED THAT THE PT UNDERWENT SUCCESSFUL REMOVAL OF THE DISPLACED STENT, FOLLOWED BY EXTENSIVE ENDARTERECTOMY WITH HEMASHIELD PATCH ANGIOPLASTY, ALONG WITH COMMON FEMORAL ARTERY ENDARTERECTOMY WITH PATCH ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R0407084

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 6 FRENCH SHEATH| SNARED DEIVCIE| 7 FRENCH SHEATH