Model Number ESS305 |
Device Problems
Device Dislodged or Dislocated (2923); Extrusion (2934)
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Patient Problems
Death (1802); Death, Intrauterine Fetal (1855)
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Event Date 06/08/2015 |
Event Type
Death
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Event Description
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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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Manufacturer Narrative
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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.
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Event Description
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of foetal death ("fetal demise/ no pulsations of the prolapsed umbilical cord nor signs of life at birth at 24 to 27 weeks") in a female neonate exposed to essure (batch no.B27985) during pregnancy.Other product or product use issues identified: foetal exposure during pregnancy "child exposure to essure during pregnancy" on (b)(6) 2014.The mother's past medical history included multigravida on (b)(6) 2013, parity 6 on (b)(6) 2013, allergic reaction to antibiotics, latex allergy, allergic rash and difficulty breathing.Previously administered products included for an unreported indication: keflex.Past adverse reactions to the above products included rash with keflex.Concurrent conditions included breast feeding, amenorrhea and female sterilization since (b)(6) 2013.On an unknown date, the (b)(6) mother had essure inserted.On (b)(6) 2015, the neonate was diagnosed with foetal death (seriousness criterion death).Last menstrual period and estimated date of delivery were not provided.The neonate was exposed to essure in place during the first and second trimesters of pregnancy.The pregnancy outcome was reported as stillbirth.The (b)(6) was the reported birth weight.The neonate died on (b)(6) 2015 and the reported cause of death was fetal death.The reporter considered foetal death to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 5.5 kg/sqm.Quality-safety evaluation of ptc: sample not available.We conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical issue involved in the complaint.A product quality defect could not be confirmed but is considered plausible.However, based on the available information a relationship with the reported medical events is not plausible.The reported medical events are not indicative of a quality deficit per se.No similar ae case reports have been received to date in relation to date in relation to the reported batch.Most recent follow-up information incorporated above includes: on 19-apr-2017: quality-safety evaluation of product technical complaint.Company causality comment: incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (reference number: (b)(4)) on 21-jul-2015.The most recent information was received on 10-feb-2020.This spontaneous case was reported by a lawyer and describes the occurrence of foetal death ('fetal demise/ no pulsations of the prolapsed umbilical cord nor signs of life at birth at 24 to 27 weeks') in a female foetus whose mother had inserted essure (batch no.B27985) during pregnancy.Other product or product use issues identified: foetal exposure during pregnancy "child exposure to essure during pregnancy/exposure to device in utero" on (b)(6) 2014.The mother's medical history included multigravida on (b)(6) 2013, parity 6 on (b)(6) 2013, allergic reaction to antibiotics, latex allergy, allergic rash and difficulty breathing.Previously administered products included for an unreported indication: keflex.Past adverse reactions to the above products included rash with keflex.Concurrent conditions included female sterilization since (b)(6) 2013, breast feeding and amenorrhea.The foetus's mother was exposed to essure during the first and second trimesters.The pregnancy outcome was reported as stillbirth.(b)(6) was the reported birth weight.On an unknown date, the (b)(6)-year-old mother had essure inserted.On (b)(6) 2015, the foetus was diagnosed with foetal death (seriousness criterion death).The foetus died on (b)(6) 2015 and the reported cause of death was fetal death.The reporter considered foetal death to be related to essure.The reporter commented: information described in the deleted case number (b)(4) (social medial case) contains discrepant information.It was reported that the baby was born four-and-a-half months early and lived for only five days (considered as a premature baby).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 5.5 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-feb-2020: quality safety evaluation of product technical complaint.This spontaneous 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 24-27 week range, and the baby had no gross deformities.This event is anticipated 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.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.Nevertheless, considering that fetal demise occurred during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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