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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION

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BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION Back to Search Results
Model Number ESS305
Device Problems Dislodged or dislocated; Extrusion
Event Date 06/08/2015
Event Type  Injury  
Manufacturer Narrative

Follow up information received on 26-aug-2015: this case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting taking place in september 2015 (case # fda-2014-n-0736-0804, awareness date 26-aug-2015). Information received states that baby's mother delivered a 25-27 week gestation baby girl who was breech. The doctor in the emergency room called the first ob that he could. The neonatologist told her that she likely could have made it in the nicu (neonatal intensive care unit) if mother's placenta hadn't abrupted. Ob arrived to the hospital and told that enough of the coil was exposed that it caused the water to break and ruptured mother's placenta and caused her to have placental abruption, which is considered an obstetric emergency. The baby was born on (b)(6) 2015 with (b)(6); and she was laid to rest on (b)(6) 2015. Follow-up from 07-sep-2015 and 09-sep-2015: no new information provided. Company causality comment: this spontaneous case report (received from a nurse via regulatory authority website) refers to a fetus who was exposed to essure (fallopian tube occlusion insert) during pregnancy and died. This event is serious due to its fatal nature and unlisted in the reference safety information for essure. In this case, the exact cause of baby death was not provided. It was informed the mother started to bleed profusely, went to emergency room and delivered a 25-27 weeks baby who died at the neonatal intensive care unit. It was also stated essure was dislodged and ruptured mother's placenta. Rupture of placenta refers to bleeding at the decidual-placental interface that causes partial or total placental detachment prior to delivery of the fetus. This condition is a significant cause of perinatal mortality. Based on this information and considering gestational age at the time of the event, a contributory role of essure in this rupture of placenta and then baby's death cannot be excluded. Given the fatal nature of event, this case is regarded as incident. According to the available information, there is no reason to suspect a quality deficit of the product. No further information is expected.

 
Event Description

 
Manufacturer Narrative

Upon internal review it was noted that the following information incorrectly submitted to 2951250-2016-00633. Follow-up information received on 27-sep-2015 received via social media ((b)(6)): no new information. Follow-up received on 28-dec-2016 from lawyer:essure lot number was b27985 (expiration date apr-2016). Consumer returned for depo provera injections on (b)(6) 2014. She had the first hsg (hysterosalpingogram) on (b)(6) 2014 which revealed spillage from left tube. A second hsg on (b)(6) 2014 revealed partial patency of left tube. On (b)(6) 2015 spontaneous rupture of membranes occurred, and partial delivery of a footling breech. On (b)(6) 2015 obstetrician performed an assisted delivery of a double footling, stillborn female baby. As there had been no pulsations of the prolapsed umbilical cord, nor signs of life at birth, no attempt at resuscitation was made. The gestational age was in the (b)(6) range. The baby had no gross deformities. Company causality comment: this spontaneous and non-medically confirmed case report refers to a fetus who was exposed to essure (fallopian tube occlusion insert) during pregnancy and suffered fetal demise. Upon receipt of follow-up information, it was clarified that no pulsations of the prolapsed umbilical cord nor signs of life at birth were present. The gestational age was in the (b)(6) range, and the baby had no gross deformities. This event is unanticipated in the reference safety information for essure. In this particular case, the mother underwent two hysterosalpingogram tests after essure insertion which showed patency of left tube, and alternative contraception was initiated (see mother´s case). Therefore the pregnancy can be regarded as a failure also of the alternative contraceptive method. A series of complications of pregnancy were reported such as spontaneous rupture of membrane and placental abruption, which likely led to the fetal demise. This case was regarded as incident due to the serious injury and fatal outcome reported. Based on the initially available information, there was no reason to suspect a causal relationship to a potential quality deficit. Since lot number was reported on follow-up, an updated technical analysis is expected. Further information will be obtained through the litigation process.

 
Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

 
Event Description

This is a spontaneous case report received via regulatory authority (case# mw5043952) in united states on 21-jul-2015. It refers to a fetus who was exposed to essure (fallopian tube occlusion insert) during pregnancy and suffered fetal demise (mother case# (b)(4) / (b)(4)). Additional information received on 21-aug-2015. According to the information provided, hysterosalpingogram was performed (unspecified date) and showed the essure did not properly form the scar tissue and her tube was still open. Consumer started taking depot shots. She had no clue she was pregnant, until a few days before, which was on a weekend, and was going to call the obstetrician on monday ((b)(6)2015). Sunday evening ((b)(6) 2015), she started bleeding profusely, went to the emergency room, and delivered a baby who was still born (gestational age not provided). As of sunday evening ((b)(6) 2015) she was very active. According to the report, essure was dislodged and was sticking out enough in her abdominal space that it ruptured her placenta, which led to fetal demise. Due to unavailable reporter contact information, no follow up can be done. Product technical complaint investigation and final assessment were received on 21-aug-2015: this adverse event report is related to a product technical complaint and was initiated due to a lack of efficacy (pregnancy). The bayer reference number for the ptc report is (b)(4). Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint. Typically, we would inspect the micro-insert to look for any manufacturing deficiencies. Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record. We are unable to confirm any quality defect or device malfunction at this time. There was no event reported which indicates a new technical failure mode for the device. Medical assessment: this ptc was initiated due to a request for confirmation of quality in association with a lack of efficacy. A contraceptive failure may occur with the use of any contraceptive and is not indicative of a quality deficit per se. The reported adverse events are not indicative of a quality deficit per se. No batch number was reported. Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible. Neither batch number nor complaint sample was available for a technical investigation. The technical assessment concluded unconfirmed quality defect. In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report. Company causality comment: this spontaneous and non-medically confirmed case report (received via regulatory authority) refers to a fetus who was exposed to essure (fallopian tube occlusion insert) during pregnancy and suffered fetal demise. This event is serious due to its fatal nature and unlisted in the reference safety information for essure. In this case, the exact cause of fetal death was not provided. It was informed the mother started to bleed profusely, went to emergency room and delivered a baby who was a stillborn. It was also stated essure was dislodged and was sticking out in her abdominal space (interpreted as device dislocation) and ruptured her placenta. In the absence of fatal congenital anomalies, stillbirths are mainly due to maternal events leading to inadequate oxygen supply to the fetus. Thus, a problem with the placenta is a viable cause for stillbirth. Based on these considerations, a contributory role of essure in this rupture of placenta and then in stillbirth and fetal demise cannot be excluded. Given the fatal nature of event, this case is regarded as incident. According to the available information, there is no reason to suspect a quality deficit of the product. No further information is expected.

 
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Brand NameESSURE
Type of DeviceINSERT, TUBAL OCCLUSION
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd.
p.o. box 915
whippany , NJ 07981-0915
MDR Report Key5027333
Report Number2951250-2015-00633
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type CONSUMER,OTHER
Type of Report Initial,Followup,Followup,Followup
Report Date 06/30/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received08/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESS305
Device LOT NumberB27985
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
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 TREATMENT DATA
Date Received: 08/25/2015 Patient Sequence Number: 1
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