BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT SELFX SELF-EXPANDING STENT SYSTEM

    MDR report key: 3183193 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03892
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 1, 2004
    Report Date
    May 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. PATIENT DATA REPORTED AS - AGE 69 MEAN (52-88); GENDER M/F = 37:22. DATE OF EVENT ESTIMATED BASED ON DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATE BASED ON DATE OF PUBLICATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF OCCLUSION IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE VASCULAR SELF X INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. ARTICLE: DILATATION BY SOEHENDRA STENT RETRIEVER IS FEASIBLE AND EFFECTIVE IN MULTIPLE DEPLOYMENT OF METALLIC STENTS TO MALIGNANT HILAR BILIARY STRICTURES.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON A LITERATURE REVIEW: BETWEEN APRIL 2004 AND APRIL 2009, 59 PATIENTS WITH MALIGNANT HILAR BILIARY STRICTURES HAD MULTIPLE METALLIC STENTS (MS) INSERTED USING A PARTIAL STENT-IN-STENT PROCEDURE. THE SUCCESS RATE WAS EVALUATED FOR MS OR PLASTIC STENT (PS) DEPLOYMENT AFTER NON-ABBOTT STENT (SSR) APPLICATION AND PROCEDURAL COMPLICATIONS. 5 OF 59 PATIENTS (8%) WERE SUBJECTED TO SSR APPLICATION FOR THE INITIAL MS DEPLOYMENT; MS WERE SUCCESSFULLY DEPLOYED IN ALL OF THESE PATIENTS (100%). MS OCCLUSION WAS NOTED IN 27 PATIENTS. SSR WAS APPLIED TO 7 PATIENTS (26%) FOR THE DEPLOYMENT OF MULTIPLE PS AFTER MS OCCLUSION. AFTER CONFIRMING THE MS OCCLUSION, RE-INTERVENTION WAS PERFORMED VIA ENDOSCOPIC PROCEDURE. NO COMPLICATIONS RELATED TO DILATATION USING SSR OCCURRED IN ANY PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282923 JOSTENT SELFX SELF-EXPANDING STENT SYSTEM SELF-EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R