N
Patient 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.
MAUDE MDR 5383707
- MDR report key
- 5383707
- Report number
- 3007240980-2016-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-06-04
- Date received
- 2016-01-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- STEPHANIE FOSSAT-DOMINGUE
- Address
- 5840 EL CAMINO REAL STE.111 CARLSBAD CA 92008 US
- Phone
- 760-760-7606
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EMBOZENE MICROSPHERES | EMBOLIC DEVICE | CELONOVA BIOSCIENCES, GMBH | NAJ | 01-0301-07002-01 | 17020-S1 | 1411053001 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-01-21 | 0 | 1. D |
Event Narratives#
D
Patient 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.
N
Patient 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.
D
Patient 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.
N
Patient 1
D
Patient 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.