BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FGE

    MDR report key: 4156689 · Received October 9, 2014

    Report

    Report Number
    1016427-2014-00109
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 1, 2014
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE IS UNKNOWN. THE EVENT DATE FOR THIS REPORT IS THE ALERT DATE OF (B)(6) 2014. THE DATE OF IMPLANTATION IS ALSO UNKNOWN. NO PATIENT INFORMATION WAS PROVIDED. NO CONTACT INFORMATION/PHONE NUMBER IS AVAILABLE. THE REPORT RECEIVED FROM A PATIENT¿S RELATIVE THROUGH THE MEDICAL AFFAIRS DEPARTMENT CALLED FOR APPOINTMENT CARD REPLACEMENT AND ADDITIONALLY REPORTED ADVERSE EVENTS. THE PATIENT HAD AN UNSPECIFIED STENT IMPLANTED IN AN UNSPECIFIED VESSEL FOR AN UNSPECIFIED REASON. THE DATE WAS NOT PROVIDED. ON A NOT SPECIFIED DATE, THE PATIENT EXPERIENCED AN UNKNOWN EVENT WHICH RESULTED IN THE NEED FOR STENTS TO BE REPLACED WHICH WAS CLARIFIED AS HAVING AN APPOINTMENT TO HAVE STENTS PUT IN HER HEART WHICH WAS UNABLE TO BE FURTHER CLARIFIED. NO FURTHER INFORMATION WAS AVAILABLE AS THE CALLER ABRUPTLY DISCONNECTED CALL. ADDITIONAL COMMENTS: IT IS AN UNSPECIFIED STENT, NOT A CYPHER STENT. NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING PATIENT OR CALLER CONTACT INFORMATION. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. MANUFACTURING RECORDS (DHR) COULD NOT BE REVIEWED, AS THE PRODUCT CATALOG AND LOT NUMBER ARE NOT AVAILABLE. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CORONARY ARTERY DISEASE. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM A PATIENT¿S RELATIVE THROUGH THE MEDICAL AFFAIRS DEPARTMENT CALLED FOR APPOINTMENT CARD REPLACEMENT AND ADDITIONALLY REPORTED ADVERSE EVENTS. THE PATIENT HAD AN UNSPECIFIED STENT IMPLANTED IN AN UNSPECIFIED VESSEL FOR AN UNSPECIFIED REASON. THE DATE WAS NOT PROVIDED. ON A NOT SPECIFIED DATE, THE PATIENT EXPERIENCED AN UNKNOWN EVENT WHICH RESULTED IN THE NEED FOR STENTS TO BE REPLACED WHICH WAS CLARIFIED AS HAVING AN APPOINTMENT TO HAVE STENTS PUT IN HER HEART WHICH WAS UNABLE TO BE FURTHER CLARIFIED. NO FURTHER INFORMATION WAS AVAILABLE AS THE CALLER ABRUPTLY DISCONNECTED CALL. ADDITIONAL COMMENTS: IT IS AN UNSPECIFIED STENT, NOT A CYPHER STENT. NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING PATIENT OR CALLER CONTACT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636607 FGE FGE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R