BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOZENE MICROSPHERES

    MDR report key: 5383707 · Received January 21, 2016

    Report

    Report Number
    3007240980-2016-00004
    Event Type
    Death
    Date Received
    January 21, 2016
    Date of Event
    June 4, 2015
    Report Date
    December 22, 2015
    Manufacturer
    CELONOVA BIOSCIENCES, GMBH
    Product Code
    NAJ
    PMA / PMN Number
    K141209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION, HOWEVER INVESTIGATION OF THE EVENT IS IN PROGRESS TO DETERMINE THE RELATIONSHIP OF THE DEVICE/PRODUCT TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A SERIOUS INCIDENT REVIEW HAS TAKEN PLACE WITH EXTERNAL EXPERTISE IN MANAGEMENT OF THIS CONDITION. AN INQUEST IS PLANNED FOR (B)(6) 2016. IN THE INTERIM THE MANAGEMENT OF THESE CASES AT THIS HOSPITAL HAS BEEN CHANGED SO THAT UTERINE ARTERY EMBOLIZATION USING EMBOZENE MICROSPHERES IS NO LONGER USED FOR THIS INDICATION. EVENT INFORMATION WAS REQUESTED FROM THE HOSPITAL, HOWEVER, THE HOSPITAL HAS NOT RELEASED ANY INFORMATION. THE HOSPITAL INDICATED THAT THE EVENT WAS NOT PRODUCT RELATED AND THEY CONTINUE TO USE EMBOZENE. BASED ON THE INFORMATION PROVIDED BY (B)(4) WE ARE ASSUMING THAT THE PATIENT SUFFERED NON-TARGET EMBOLIZATION THROUGH SHUNTING TO THE VENOUS SYSTEM AND SUBSEQUENTLY TO THE LUNG, WHICH SUPPORTS THE FINDING PROVIDED BY THE (B)(4). HOWEVER, THIS HAS NOT BEEN CONFIRMED BY THE HOSPITAL. THEREFORE, AT THIS TIME, THE CAUSE OF DEATH SEEMS TO BE MULTIFACTORIAL TRIGGERED BY THE MANAGEMENT OF PLACENTA PERCRETA AND HAEMORRHAGE, ALTHOUGH THE PROCEDURE AND THE DEVICE COULD NOT BE RULED OUT. NO ACTION WILL BE TAKEN AT THIS TIME AS THERE IS NO EVIDENCE THAT THE MICROSPHERES WERE THE CAUSE OF THE DEATH. ADDITIONALLY, THIS IS A FIRST TIME OCCURRENCE OF THIS TYPE OF EVENT AND NO EVIDENCE THAT THE PRODUCT POSES A HEALTH THREAT.

    Description of Event or Problem · 1

    ON (B)(6) 2015 PATIENT HAD A CAESAREAN SECTION FOR A KNOWN PLACENTA PERCRETA (SEVERE FORM OF ABNORMALLY ADHERENT PLACENTA). THE BABY WAS DELIVERED AT CAESAREAN SECTION BUT THE PLACENTA WAS RETAINED. THE INTENTION WAS TO PERFORM A HYSTERECTOMY AT A LATER DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2015 PATIENT HAD A CEASEAREAN SECTION FOR A KNOWN PLACENTA PERCRETA (SEVERE FORM OF ABNORMALLY ADHERENT PLACENTA). THE BABY WAS DELIVERED AT CAESAREAN SECTION BUT THE PLACENTA WAS RETAINED. THE INTENTION WAS TO PERFORM A HYSTERECTOMY AT A LATER DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2015 PATIENT HAD HAD A CAESAREAN SECTION FOR A KNOWN PLACENTA PERCRETA (SEVERE FORM OF ABNORMALLY ADHERENT PLACENTA). THE BABY WAS DELIVERED AT CAESAREAN SECTION BUT THE PLACENTA WAS RETAINED. THE INTENTION WAS TO PERFORM A HYSTERECTOMY AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42329 EMBOZENE MICROSPHERES EMBOLIC DEVICE NAJ CELONOVA BIOSCIENCES, GMBH 01-0301-07002-01 1411053001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death