BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS 29MM BILIARY

    MDR report key: 3181554 · Received June 21, 2013

    Report

    Report Number
    1016427-2013-00083
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    October 7, 2005
    Report Date
    May 29, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K020809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DANON ET AL RELIABLE ATRIAL SEPTOSTOMY BY STENTING OF THE ATRIAL SEPTUM; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 66:408¿413 (2005); REPORTED THAT FOLLOWING ATRIAL SEPTOSTOMY WITH PLACEMENT OF A PALMAZ STENT ONE PATIENT EXPERIENCED STENT MIGRATION. NO PATIENT INJURY WAS REPORTED. IN THIS STUDY, CONGENITAL HEART DISEASE PATIENTS WERE TREATED WITH ATRIAL SEPTOSTOMY BY STENTING. SIX OF THE THIRTEEN PATIENTS¿ STENTS WERE REMOVED BETWEEN ONE AND EIGHTEEN MONTHS FOLLOWING IMPLANTATION. REMOVAL WAS REPORTEDLY DUE TO REASONS SUCH AS HEART TRANSPLANTATION, PALLIATIVE SURGERY AND CORRECTIVE SURGERY. IN THIS CASE, AT THE TIME OF REMOVAL, THE STENT WAS NOTED TO HAVE HAD EXTEND ALMOST TO THE FREE RIGHT ATRIAL WALL BUT DID NOT CAUSE A PROBLEM. THE PRODUCT WAS NOT RETURNED AS IT REMAINED IMPLANTED IN THE PATIENT. THE LOT NUMBER WAS NOT REPORTED AND A DHR COULD NOT BE COMPLETED. WITHOUT RETURN OF THE DEVICE OR FILMS TO REVIEW, THE REPORTED ¿STENT ¿ MIGRATION¿ COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE AND THE FULL ARTICLE IS ATTACHED. THE CITATION IS AS FOLLOWS: DANON ET AL RELIABLE ATRIAL SEPTOSTOMY BY STENTING OF THE ATRIAL SEPTUM; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 66:408¿413.

    Description of Event or Problem · 1

    DANON ET AL RELIABLE ATRIAL SEPTOSTOMY BY STENTING OF THE ATRIAL SEPTUM; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 66:408¿413 (2005); REPORT ONE PATIENT HAD A STENT EXTEND ALMOST TO THE FREE RIGHT ATRIAL WALL AT THE TIME OF ITS REMOVAL. ALTHOUGH IT DID NOT CAUSE A PROBLEM, THERE MAY BE RISK OF STENT EROSION THROUGH THE FREE WALL OF THE ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281890 PALMAZ GENESIS 29MM BILIARY ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ASPIRIN