Model Number 01-0301-07002-01 |
Device Problem
Therapy Delivered to Incorrect Body Area (1508)
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Patient Problem
Sudden Cardiac Death (2510)
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Event Date 06/04/2015 |
Event Type
Death
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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This report is being sent to correct the model, catalog, and lot number, which were incorrect on the previous initial report.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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On (b)(6) 2015 patient had 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 hyserectomy at a later date.
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Event Description
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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.
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Search Alerts/Recalls
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