BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS 29MM BILIARY

    MDR report key: 3181716 · Received June 21, 2013

    Report

    Report Number
    1016427-2013-00086
    Event Type
    Injury
    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 A ONE PATIENT WHOSE STENT WAS REMOVED BETWEEN 1-18 MONTHS AFTER PLACEMENT, HAD A THROMBUS ON THE RIGHT ATRIAL SIDE OF THE STENT. THIS PATIENT DID NOT HAVE ANY EMBOLIC PHENOMENA OR OTHER POTENTIAL CLINICAL SEQUELAE FROM THE THROMBUS. 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. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. SEVERAL FACTORS, INCLUDING MECHANICAL PLAQUE DISRUPTION, INTIMAL INJURY, AND STENT THROMBOGENICITY PREDISPOSE THE PATIENT TO THROMBOEMBOLIC EVENTS. PLATELET ADHESION, ACTIVATION, AND AGGREGATION PLAY MAIN ROLES IN MURAL THROMBUS FORMATION. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. 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 A ONE PATIENT WHOSE STENT WAS REMOVED BETWEEN 1-18 MONTHS AFTER PLACEMENT, HAD A THROMBUS ON THE RIGHT ATRIAL SIDE OF THE STENT. THIS PATIENT DID NOT HAVE ANY EMBOLIC PHENOMENA OR OTHER POTENTIAL CLINICAL SEQUELAE FROM THE THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283260 PALMAZ GENESIS 29MM BILIARY ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening