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This spontaneous case report was received from a gynecologist/obstetrician in the united states on (b)(4) 2014.It describes the occurrence of positive blood pregnancy test, levels were elevated (device ineffective) in a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted.No information was given on patient's history, past drugs, concomitant medication and concurrent conditions.On (b)(6) 2012, the patient had essure (fallopian tube occlusion insert), lot number 932164, inserted.The patient had an hsg (hysterosalpingogram) test on (b)(6) 2012 that showed bilateral tubal occlusion.In the week before time of reporting (in (b)(6) 2014), the patient had a blood pregnancy test that was positive and the levels were elevated.An ultrasound did not show a pregnancy, and patient will be having more blood work and an ultrasound in the week after time of reporting.Essure was continued.Reporter did not assess device-event relationship.Follow up information received on 20-feb-2014.Three follow up attempts with no response.Follow-up information was received on 25-feb-2014 from physician: the patient's medical history included a leep (loop electrocautery excision procedure) in 2009.The patient had 3 pregnancies with 3 deliveries in history.There were no abortions (spontaneous, elective or therapeutic) and no ectopic pregnancies.The patient's demographic information were updated.Bmi: (b)(6).At 12 weeks post partum the patient had essure inserted on (b)(6) 2012, with lot number 932164.The physician described that the procedure was performed under sedation and anesthesia.The procedure was described as easy, without fluid loss.A cervical dilatation was made, sounding was 6 mm.The visualization of tubal ostium was easy.On (b)(6) 2012 hysterosalpingography was performed and she used depo-provera as back-up contraception.On (b)(6) 2013 her last menstrual period occurred.On (b)(6) 2014 the first blood test was performed and it confirmed the pregnancy ((b)(6)).On (b)(6) 2014 blood test was performed ((b)(6)).In 2014, an ultrasound was performed and it showed a single uterine pregnancy.The date of the first day of the patient's last menstrual period was (b)(6) 2013.At the time of the report no complications were known.Expected delivery date was (b)(6) 2014.The patient continued with pregnancy.Essure was not removed, no removal was planned.Ptc investigation result was received on 25-apr-2014.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: (b)(4).Final assessment: lot history record (lhr) reviewed.Product met product release specifications.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: the events reported are possible undesirable events with the use of essure.Lack of effectiveness in itself is not necessarily indicative of a quality defect as it may occur with the use of any product.Additionally, pregnancy may occur during any contraceptive use.No complaint sample was provided for a technical investigation.Three (3) additional ae case reports have been received to date in relation to batch number 932164 but none of these cases refers to any similar type of event.No batch signal could be identified at this time.The review of the lot history records confirmed that the product met product release specifications.At the time of this medical assessment the technical investigation concluded unconfirmed quality defect.Based on the information available, there is no reason to suspect a quality defect.Follow-up information from pregnancy questionnaire, medical records and pathology results were received from physician on 12-jan-2015: upgraded to incident.On (b)(6) 2014, the patient had a vaginal delivery that was induced at 38.6 weeks due to low afi (amniotic fluid index).She had 1 live birth.The weight of infant was 3664 grams and the apgar scores were 8 and 9 at 1 min and 5 min, respectively.Mother and infant had no complications during delivery.On (b)(6) 2014, a mini exploratory laparotomy with partial bilateral salpingectomies and removal of essure was done, because patient desired permanent sterilization, post partum.During the procedure, left essure coil was felt and seen to be protruding from left cornual region.The tube was then followed out to tis fimbriated end and a complete fimbriectomy and partial salpingectomy were performed.The tube was doubled tied and tube was allowed to return to abdominal cavity.The right tube was identified and followed out to its fimbriated end and a partial salpingectomy and fimbriectomy was performed again without incident.The right coil was not seen and was not removed, but it was palpated within remaining tube.The surgical pathology result showed that benign left and right fallopian tube but only the left portion included a medical device consistent with essure.Patient recovered from essure removal procedure.According the physician, the unplanned pregnancy was caused by essure.Ptc investigation result update received on 16-jan-2015.The ptc global reference number for this report is (b)(4).Final assessment: lot number 932164, manufacturing date: dec-2011, expiration date: dec-2014.Case upgraded to incident.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.In this case, 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.No new failure mode has been identified.Medical assessment: this ptc was initiated due to a lack of efficacy.Contraceptive failure may occur under the use of any contraceptive and is not indicative of a quality defect per se.Three further ae case reports have been received to date in relation to the reported batch, none of them referring to a similar lack of efficacy type of event.No batch signal could be identified.The batch documentation of the reported batch was reviewed.No complaint sample was provided for a technical investigation at this point in time.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 medically confirmed, spontaneous case report refers to a (b)(6) female patient who had a positive blood pregnancy test about 1 year and 7 months after essure (fallopian tube occlusion insert) insertion.When she was 38.6 weeks pregnant, labor was induced due to low amniotic fluid volume and she gave birth to a healthy child.During post-partum laparotomy, the left essure coil was felt and seen to be protruding from left cornual region, interpreted as device embedded (partial perforation).Perforation and low amniotic fluid index are serious due to medical importance while the event pregnancy is non-serious.Perforation and pregnancy are listed in essure's reference safety information but low amniotic fluid index is unlisted.Uterine perforation may occur with any trans-cervical intrauterine procedure.In this case, even though the perforation was diagnosed at the time of removal, since it occurred after essure placement, this event was considered related to essure.This perforation could explain the pregnancy, however, it is not possible to determine, in this case, if pregnancy occurred as a consequence of perforation or ineffective device.Therefore pregnancy was also considered related to essure.Oligohydramnios refers to amniotic fluid volume that is less than expected for gestational age.If diagnosed in the third trimester, is often associated with preterm premature rupture of membranes or with uteroplacental insufficiency due to conditions such as preeclampsia or other maternal vascular diseases.In this case,the reported event was considered as related to essure due to the lack of alternative explanation and considering that a mechanical interference of the essure device in the amniotic sac cannot be excluded.This case is regarded as incident due to the labor induction (medical required intervention).According to product technical analysis, there is no reason to suspect a causal relationship to a potential quality deficit.
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Follow up 25-jul-2016: perforation questionnaire received back from physician.The day of last menstrual period before insertion was on (b)(6) 2012.The patient was 3 months post-partum on depo provera and her last delivery was not a c-section.She was not breastfeeding at time of insertion.No abnormal findings.On (b)(6) 2014 the patient presented do the doctor's office with pregnancy of 4 weeks.The date of diagnosis of incorrect essure position was reported as (b)(6) 2014 and the diagnosis was done via minilaparotomy for postpartum tubal on (b)(6) 2014 (inconsistent information).Physician reported that right essure was in correct position and was not removed.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had a positive blood pregnancy test about 1 year and 7 months after essure (fallopian tube occlusion insert) insertion.When she was (b)(6) pregnant, labor was induced due to low amniotic fluid volume and she gave birth to a healthy child.During post-partum laparotomy, the left essure coil was felt and seen to be protruding from left cornual region (perforation on left side through left cornea).Perforation and pregnancy are listed in essure's reference safety information but low amniotic fluid index is unlisted.Uterine perforation may occur with any trans-cervical intrauterine procedure.In this case, even though the perforation was diagnosed at the time of removal, since it occurred after essure placement, this event was considered related to essure.This perforation could explain the pregnancy, however, it is not possible to determine, in this case, if pregnancy occurred as a consequence of perforation or ineffective device.Therefore pregnancy was also considered related to essure.Oligohydramnios refers to amniotic fluid volume that is less than expected for gestational age.If diagnosed in the third trimester, is often associated with preterm premature rupture of membranes or with uteroplacental insufficiency due to conditions such as preeclampsia or other maternal vascular diseases.In this case, the reported event was considered as related to essure due to the lack of alternative explanation and considering that a mechanical interference of the essure device in the amniotic sac cannot be excluded.This case is regarded as incident due to the labor induction (medical required intervention).According to product technical analysis, there is no reason to suspect a causal relationship to a potential quality deficit.
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