BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 2944763 · Received February 5, 2013

    Report

    Report Number
    3008853977-2013-00018
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: OTHER FOR ANTICIPATED PROCEDURAL COMPLICATION.THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THROMBUS AND OTHER ASSOCIATED COMPLICATIONS ARE KNOWN AND ANTICIPATED PHYSIOLOGICAL EFFECTS OF THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PRESENTATION BY A PHYSICIAN DURING A MEETING THAT THROMBUS FORMATION AND HERNIATION OF THE THROMBUS INTO THE PARENT VESSEL WAS OBSERVED AT THE NECK OF THE ANEURYSM DURING PROCEDURE. THE CLOT WAS SUCCESSFULLY TREATED WITH LYTICS DURING THE PROCEDURE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PRESENTATION BY A PHYSICIAN DURING A MEETING THAT THROMBUS FORMATION AND HERNIATION OF THE THROMBUS INTO THE PARENT VESSEL WAS OBSERVED AT THE NECK OF THE ANEURYSM DURING PROCEDURE. THE CLOT WAS SUCCESSFULLY TREATED WITH LYTICS DURING THE PROCEDURE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47819 UNKNOWN_NEUROVASCULAR_PRODUCT DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC CORK, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention