BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ GENESIS 29MM BILIARY

    MDR report key: 3181683 · Received June 21, 2013

    Report

    Report Number
    1016427-2013-00085
    Event Type
    Death
    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
    Adverse Event
    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); REPORT DEATH OF A NEWBORN WITH HYPOPLASTIC LEFT HEART AND INTACT ATRIAL SEPTUM. SHE HAD THE STENT PLACED ON HER FIRST DAY OF LIFE AND CLINICALLY IMPROVED FOLLOWING THE PROCEDURE; HOWEVER, HER CONDITION DETERIORATED AND SHE DIED AT 3 DAYS OF LIFE. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE IS NO STERILE LOT NUMBER AVAILABLE; THEREFORE A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. DEATH IS A KNOWN POTENTIAL OUTCOME OF STENTING. PATIENT FACTORS INCLUDING THE PATIENT¿S PRE-EXISTING HYPOPLASTIC LEFT HEART AND INTACT ATRIAL SEPTUM MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION IS REQUIRED. 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 (2005).

    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 DEATH OF A NEWBORN WITH HYPOPLASTIC LEFT HEART AND INTACT ATRIAL SEPTUM. SHE HAD THE STENT PLACED ON HER FIRST DAY OF LIFE AND CLINICALLY IMPROVED FOLLOWING THE PROCEDURE; HOWEVER, HER CONDITION DETERIORATED AND SHE DIED AT 3 DAYS OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282101 PALMAZ GENESIS 29MM BILIARY ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Death