MAUDE Adverse Event Report: CELONOVA BIOSCIENCES, GMBH EMBOZENE MICROSPHERES; EMBOLIC DEVICE

Model Number 01-0301-07002-01

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Sudden Cardiac Death (2510)

Event Date 06/04/2015

Event Type  Death  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

A serious incident review has taken place with external expertise in management of this condition.An inquest is planned for june 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)(6), 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)(6).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.

Event Description

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.

Event Description

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.

• Brand Name: EMBOZENE MICROSPHERES
• Type of Device: EMBOLIC DEVICE
• Manufacturer (Section D): CELONOVA BIOSCIENCES, GMBH; ernst-abbe-str. 40 d-89079; ulm, ; GM
• Manufacturer (Section G): CELONOVA BIOSCIENCES, GMBH; ernst-abbe-strausse; 40 d-8907; ulm, ; GM
• Manufacturer Contact: stephanie fossat-domingue ; 5840 el camino real; ste.111; carlsbad, CA 92008 ; 7606037008
• MDR Report Key: 5383889
• MDR Text Key: 36569652
• Report Number: 3007240980-2016-00005
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01-0301-07002-01
• Device Catalogue Number: 17020-S1
• Device Lot Number: 1410163002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death