MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-01-21 for EMBOZENE MICROSPHERES 01-0301-05002-01 15020-S1 manufactured by Celonova Biosciences, Gmbh.
[36531110]
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.
Patient Sequence No: 1, Text Type: N, H10
[36531111]
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.
Patient Sequence No: 1, Text Type: D, B5
[40736305]
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.
Patient Sequence No: 1, Text Type: N, H10
[40736306]
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.
Patient Sequence No: 1, Text Type: D, B5
[43884098]
Patient Sequence No: 1, Text Type: N, H10
[43884099]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007240980-2016-00001 |
| MDR Report Key | 5383238 |
| Report Source | FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2015-12-22 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2015-12-22 |
| Date Added to Maude | 2016-01-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE FOSSAT-DOMINGUE |
| Manufacturer Street | 5840 EL CAMINO REAL STE.111 |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7606037008 |
| Manufacturer G1 | CELONOVA BIOSCIENCES, GMBH |
| Manufacturer Street | ERNST-ABBE-STRAUSSE 40 D-8907 |
| Manufacturer City | ULM, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOZENE MICROSPHERES |
| Generic Name | EMBOLIC DEVICE |
| Product Code | NAJ |
| Date Received | 2016-01-21 |
| Model Number | 01-0301-05002-01 |
| Catalog Number | 15020-S1 |
| Lot Number | 1503173002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELONOVA BIOSCIENCES, GMBH |
| Manufacturer Address | ERNST-ABBE-STR. 40 D-89079 ULM, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-01-21 |