| Model Number ESS305 |
| Device Problems
Break (1069); Device Inoperable (1663); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Abortion (1688); Menstrual Irregularities (1959); Miscarriage (1962); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193); Pregnancy with a Contraceptive Device (4517); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/12/2011 |
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Event Type
malfunction
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Event Description
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This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device breakage ("device breakage"), abortion spontaneous ("miscarriage/pregnancy (stillbirth or miscarriage)") and pregnancy with contraceptive device ("unexpected post-implant pregnancy") in a (b)(6) year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffect".The patient's past medical history included obesity, multigravida and parity 4 ((b)(6) 2001, (b)(6) 2005, (b)(6) 2006 and (b)(6) 2010).She did not allege that essure caused birth defects.Previously administered products included for an unreported indication: morphine.Past adverse reactions to the above products included hypersensitivity with morphine.Concurrent conditions included pap smear abnormal and inflammation.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, 1 day after insertion of essure, the patient experienced pelvic pain ("severe pelvic pain/pain").On (b)(6) 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with pelvic pain.On (b)(6) 2011, the patient experienced abortion spontaneous (seriousness criterion medically significant) with haemorrhage in pregnancy.In (b)(6) 2011, the patient experienced device breakage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding") and menorrhagia ("abnormal bleeding (menorrhagia) ").In 2011, the patient experienced dysmenorrhoea ("dysmenorrhea").On an unknown date, the patient experienced complication of device insertion ("pregnancy (with complications)/coil was not able to be implanted into right fallopian tube").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (a suction d&c was performed).Essure treatment was not changed.At the time of the report, the device breakage, abortion spontaneous, pregnancy with contraceptive device, pelvic pain, complication of device insertion, vaginal haemorrhage, menorrhagia and dysmenorrhoea outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, complication of device insertion, device breakage, dysmenorrhoea, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 32.4 kg/sqm.Smear cervix - on (b)(6) 2014: inflammation.Ultrasound antenatal screen - on (b)(6) 2011: absent fetal heartbeat; in 2011: fetal heartbeat confirmed.On (b)(6) 2009, surgical pathology revealed undersigned-placenta size-18.5x15.0x2.0xcm weight: 517.5gm, shape: discoid, umbilical cord: length received two parts, attached portion 34.0cm separately submitted portion 14.0cm insertion ecentric 1.7cm from the margin, membranes insertion markedly disrupted however, attached portion on inserts marginally, appearance normal, fetal face: blue gray , partially green linged, and highly vascularized, maternal surface: two areas of fibrin deposition, 0.7 and 1.9cm ingreatst dimension.Nodepressed areas or attached blood clot is grossly identified.Parenchyma normal.Diagnosis: third trimester placenta with three vessel cord and chorioamniotlc membranes , without inflammation.On (b)(6) 2010, hysterosalpingogram revealed total bilateral occlusion, only left coil was implanted, but hsg showed that both tubes were occluded.On (b)(6) 2011, ultrasound antenatal screenrevealed the size of the gestational sac was six weeks and four days.And the fetal pole was visible but there was no fetal heartbeat as previously seen, this patient was offered a dilation and curettage which she had chosen to proceed.Laparoscopic findings revealed normal adnexal structures, normal fallopian tubes, and the appendix was also found and seen to be normal.The uterus measured about 8 weeks in size.After completion of the procedure, repeat laparoscopy revealed no perforation of the uterus.Surgical pathology revealed container designation product of conception: thespecimen consists of suction cup devicecontaining a 5.0x4.5x3.0 cm aggregate of tan rubbery decidua and pailliferous non/hydropic, there was no fetal somatic tissue identified and representative sections are submitted in block a1.Diagnosis: uterine contents: inflamed dec,dua ahd placental tissue with degenerative changes.On (b)(6) 2014, histologic examination was performed.Current weight: (b)(6).Approximate weight at the time of essure placement: (b)(6).Quality-safety evaluation of ptc: sample not available.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.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 failure mode for the device.Based on the provided information, the defect type corresponds to the following meddra llt: device ineffective.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the medical events and lack of efficacy are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 14-may-2018: pfs received.New events: device breakage, vaginal bleeding, menorrhagia and dysmenorrhea.Case upgraded to incident.Incident.No lot number or sample available for investigation.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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage'), abortion spontaneous ('miscarriage/pregnancy (stillbirth or miscarriage)') and pregnancy with contraceptive device ('unexpected post-implant pregnancy') in a (b)(6) year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffect".The patient's medical history included obesity, multigravida and parity 4 ((b)(6) 2001, (b)(6) 2005, (b)(6) 2006 and (b)(6) 2010).She did not allege that essure caused birth defects.*on (b)(6) 2009, surgical pathology revealed undersigned-placenta size-18.5x15.0x2.0xcm weight: 517.5gm, shape: discoid, umbilical cord: length received two parts, attached portion 34.0cm separately submitted portion 14.0cm insertion ecentric 1.7cm from the margin, membranes insertion markedly disrupted however, attached portion on inserts marginally, appearance normal, fetal face: blue gray , partially green linged, and highly vascularized, maternal surface: two areas of fibrin deposition, 0.7 and 1.9cm ingreatst dimension.Nondepressed areas or attached blood clot is grossly identified.Parenchyma normal.Diagnosis: third trimester placenta with three vessel cord and chorioamniotic membranes , without inflammation.On (b)(6) 2010, hysterosalpingogram revealed total bilateral occlusion, only left coil was implanted, but hsg showed that both tubes were occluded.On (b)(6) 2011, ultrasound antenatal screen revealed the size of the gestational sac was six weeks and four days.And the fetal pole was visible but there was no fetal heartbeat as previously seen, this patient was offered a dilation and curettage which she had chosen to proceed.Laparoscopic findings revealed normal adnexal structures, normal fallopian tubes, and the appendix was also found and seen to be normal.The uterus measured about 8 weeks in size.After completion of the procedure, repeat laparoscopy revealed no perforation of the uterus.Surgical pathology revealed container designation product of conception: the specimen consists of suction cup device containing a 5.0x4.5x3.0 cm aggregate of tan rubbery decidua and pailliferous non/hydropic, there was no fetal somatic tissue identified and representative sections are submitted in block a1.Diagnosis: uterine contents: - inflamed dec,dua ahd placental tissue with degenerative changes.On (b)(6) 2014, histologic examination was performed.Current weight: (b)(6).Approximate weight at the time of essure placement: (b)(6).Previously administered products included for an unreported indication: morphine.Past adverse reactions to the above products included hypersensitivity with morphine.Concurrent conditions included pap smear abnormal, inflammation and seizures.Concomitant products included gabapentin since 2016 and rivaroxaban (xarelto) since 2016.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced pelvic pain ("severe pelvic pain/pain"), 1 day after insertion of essure.On (b)(6) 2011, the patient experienced abortion spontaneous (seriousness criterion medically significant) with haemorrhage in pregnancy and was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) with pelvic pain.In (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea").In (b)(6) 2011, the patient experienced device breakage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding") and heavy menstrual bleeding ("abnormal bleeding (menorrhagia)").On an unknown date, the patient experienced complication of device insertion ("pregnancy (with complications)/coil was not able to be implanted into right fallopian tube"), depression ("depression") and anxiety ("mental anguish").The patient was treated with surgery (a suction d&c was performed).Essure treatment was not changed.At the time of the report, the device breakage, abortion spontaneous, pregnancy with contraceptive device, pelvic pain, complication of device insertion, vaginal haemorrhage, heavy menstrual bleeding, dysmenorrhoea, depression and anxiety outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 4.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, anxiety, complication of device insertion, depression, device breakage, dysmenorrhoea, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: discrepancy noted in lab data as mentioned follows -total bilateral occlusion was mentioned as per the hysterosalpingogram performed on 27-aug-2010, where as device was placed on left side only and coil was not able to be implanted into right fallopian tube due to blockage from either a previous disease or the angle of tube insertion details-3-4 coils noted at left side.Several attempts failed to cannulate right fallopian tube.It appeared this tube was possible obstructed or in spasm.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.8 kg/sqm.Smear cervix - on (b)(6) 2014: results: inflammation.Ultrasound antenatal screen - on (b)(6) 2011: results: absent fetal heartbeat; in 2011: results: fetal heartbeat confirmed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-jun-2021: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage'), abortion spontaneous ('miscarriage/pregnancy (stillbirth or miscarriage)') and pregnancy with contraceptive device ('unexpected post-implant pregnancy') in a (b)(6) year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffect".The patient's medical history included obesity, multigravida and parity 4 ((b)(6) 2001, (b)(6) 2005, (b)(6) 2006 and (b)(6) 2010).She did not allege that essure caused birth defects.*on (b)(6) 2009, surgical pathology revealed undersigned-placenta size-18.5x15.0x2.0xcm weight: 517.5gm, shape: discoid, umbilical cord: length received two parts, attached portion 34.0cm separately submitted portion 14.0cm insertion ecentric 1.7cm from the margin, membranes insertion markedly disrupted however, attached portion on inserts marginally, appearance normal, fetal face: blue gray, partially green linged, and highly vascularized, maternal surface: two areas of fibrin deposition, 0.7 and 1.9cm ingreatst dimension.Nondepressed areas or attached blood clot is grossly identified.Parenchyma normal.Diagnosis: third trimester placenta with three vessel cord and chorioamniotic membranes , without inflammation.On (b)(6) 2010, hysterosalpingogram revealed total bilateral occlusion, only left coil was implanted, but hsg showed that both tubes were occluded.On (b)(6) 2011, ultrasound antenatal screen revealed the size of the gestational sac was six weeks and four days.And the fetal pole was visible but there was no fetal heartbeat as previously seen, this patient was offered a dilation and curettage which she had chosen to proceed.Laparoscopic findings revealed normal adnexal structures, normal fallopian tubes, and the appendix was also found and seen to be normal.The uterus measured about 8 weeks in size.After completion of the procedure, repeat laparoscopy revealed no perforation of the uterus.Surgical pathology revealed container designation product of conception: the specimen consists of suction cup device containing a 5.0x4.5x3.0 cm aggregate of tan rubbery decidua and pailliferous non/hydropic, there was no fetal somatic tissue identified and representative sections are submitted in block a1.Diagnosis: uterine contents: - inflamed dec,dua ahd placental tissue with degenerative changes.On (b)(6) 2014, histologic examination was performed.Current weight: (b)(6).Approximate weight at the time of essure placement:.Previously administered products included for an unreported indication: morphine.(b)(6).On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced pelvic pain ("severe pelvic pain/pain"), 1 day after insertion of essure.On (b)(6) 2011, the patient experienced abortion spontaneous (seriousness criterion medically significant) with haemorrhage in pregnancy and was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) with pelvic pain.In (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea").In (b)(6) 2011, the patient experienced device breakage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding") and heavy menstrual bleeding ("abnormal bleeding (menorrhagia)").On an unknown date, the patient experienced complication of device insertion ("pregnancy (with complications)/coil was not able to be implanted into right fallopian tube"), depression ("depression") and anxiety ("mental anguish").The patient was treated with surgery (a suction d&c was performed).Essure treatment was not changed.At the time of the report, the device breakage, abortion spontaneous, pregnancy with contraceptive device, pelvic pain, complication of device insertion, vaginal haemorrhage, heavy menstrual bleeding, dysmenorrhoea, depression and anxiety outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 4.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, anxiety, complication of device insertion, depression, device breakage, dysmenorrhoea, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: discrepancy noted in lab data as mentioned follows -total bilateral occlusion was mentioned as per the hysterosalpingogram performed on 27-aug-2010, where as device was placed on left side only and coil was not able to be implanted into right fallopian tube due to blockage from either a previous disease or the angle of tube insertion details-3-4 coils noted at left side.Several attempts failed to cannulate right fallopian tube.It appeared this tube was possible obstructed or in spasm.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.8 kg/sqm.Smear cervix - on (b)(6) 2014: results: inflammation.Ultrasound antenatal screen - on 27-apr-2011: results: absent fetal heartbeat; in 2011: results: fetal heartbeat confirmed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-jun-2021: correction received-rcc updated.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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Rospective pregnancy case was reported by a lawyer and describes the occurrence of device breakage ("device breakage"), abortion spontaneous ("miscarriage/pregnancy (stillbirth or miscarriage)") and pregnancy with contraceptive device ("unexpected post-implant pregnancy") in a 26-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffectual".The patient's past medical history included obesity, multigravida and parity 4 ((b)(6) 2001, (b)(6) 2005, (b)(6) 2006 and (b)(6) 2010).She did not allege that essure caused birth defects.Previously administered products included for an unreported indication: morphine.Past adverse reactions to the above products included hypersensitivity with morphine.Concurrent conditions included pap smear abnormal and inflammation.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, 1 day after insertion of essure, the patient experienced pelvic pain ("severe pelvic pain/pain").On (b)(6) 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with pelvic pain.On (b)(6) 2011, the patient experienced abortion spontaneous (seriousness criterion medically significant) with haemorrhage in pregnancy.In (b)(6) 2011, the patient experienced device breakage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding") and menorrhagia ("abnormal bleeding (menorrhagia)").In 2011, the patient experienced dysmenorrhoea ("dysmenorrhea").On an unknown date, the patient experienced complication of device insertion ("pregnancy (with complications)/coil was not able to be implanted into right fallopian tube").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (a suction d&c was performed).Essure treatment was not changed.At the time of the report, the device breakage, abortion spontaneous, pregnancy with contraceptive device, pelvic pain, complication of device insertion, vaginal haemorrhage, menorrhagia and dysmenorrhoea outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, complication of device insertion, device breakage, dysmenorrhoea, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 32.4 kg/sqm.Smear cervix on (b)(6) 2014: inflammation.Ultrasound antenatal screen on (b)(6) 2011: absent fetal heartbeat; in 2011: fetal heartbeat confirmed.On (b)(6) 2009, surgical pathology revealed undersigned-placenta size-18.5x15.0x2.0xcm weight: 517.5gm, shape: discoid, umbilical cord: length received two parts, attached portion 34.0cm separately submitted portion 14.0cm insertion ecentric 1.7cm from the margin, membranes insertion markedly disrupted however, attached portion on inserts marginally, appearance normal, fetal face: blue gray , partially green linged, and highly vascularized, maternal surface: two areas of fibrin deposition, 0.7 and 1.9cm ingreatst dimension.Nondepressed areas or attached blood clot is grossly identified.Parenchyma normal.Diagnosis: third trimester placenta with three vessel cord and chorioamniotic membranes , without inflammation.On (b)(6) 2010, hysterosalpingogram revealed total bilateral occlusion, only left coil was implanted, but hsg showed that both tubes were occluded.On (b)(6) 2011, ultrasound antenatal screen revealed the size of the gestational sac was six weeks and four days.And the fetal pole was visible but there was no fetal heartbeat as previously seen, this patient was offered a dilation and curettage which she had chosen to proceed.Laparoscopic findings revealed normal adnexal structures, normal fallopian tubes, and the appendix was also found and seen to be normal.The uterus measured about 8 weeks in size.After completion of the procedure, repeat laparoscopy revealed no perforation of the uterus.Surgical pathology revealed container designation product of conception: the specimen consists of suction cup device containing a 5.0x4.5x3.0 cm aggregate of tan rubbery decidua and papilliferous non/hydropic, there was no fetal somatic tissue identified and representative sections are submitted in block a1.Diagnosis: uterine contents: - inflamed dec,dua ahd placental tissue with degenerative changes.On (b)(6) 2014, histologic examination was performed.Current weight: 186 lbs.Approximate weight at the time of essure placement: 179 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-jul-2018: quality-safety evaluation of ptc (product technical compliant).Incident: no lot number or sample available for investigation.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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Prospective pregnancy case was reported by a lawyer and describes the occurrence of device breakage ("device breakage"), abortion spontaneous ("miscarriage/pregnancy (stillbirth or miscarriage)") and pregnancy with contraceptive device ("unexpected post-implant pregnancy") in a 26-year-old female patient (gravida 5, para 4) who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's past medical history included obesity, multigravida and parity 4 ((b)(6) 2001,(b)(6) 2005, (b)(6) 2006 and (b)(6) 2010).She did not allege that essure caused birth defects.Previously administered products included for an unreported indication: morphine.Past adverse reactions to the above products included hypersensitivity with morphine.Concurrent conditions included pap smear abnormal, inflammation and seizures.Concomitant products included gabapentin since 2016 and rivaroxaban (xarelto) since 2016.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, 1 day after insertion of essure, the patient experienced pelvic pain ("severe pelvic pain/pain").On (b)(6) 2011, the patient experienced abortion spontaneous (seriousness criterion medically significant) with haemorrhage in pregnancy and pregnancy with contraceptive device (seriousness criterion medically significant) with pelvic pain.In (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea").In (b)(6) 2011, the patient experienced device breakage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding") and menorrhagia ("abnormal bleeding (menorrhagia)").On an unknown date, the patient experienced complication of device insertion ("pregnancy (with complications)/coil was not able to be implanted into right fallopian tube"), depression ("depression") and anxiety ("mental anguish").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first trimester of pregnancy.The patient was treated with surgery (a suction d&c was performed).Essure treatment was not changed.At the time of the report, the device breakage, abortion spontaneous, pregnancy with contraceptive device, pelvic pain, complication of device insertion, vaginal haemorrhage, menorrhagia, dysmenorrhoea, depression and anxiety outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, anxiety, complication of device insertion, depression, device breakage, dysmenorrhoea, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.8 kg/sqm.Smear cervix - on (b)(6) 2014: inflammation.Ultrasound antenatal screen - on (b)(6) 2011: absent fetal heartbeat; in 2011: fetal heartbeat confirmed.On (b)(6) 2009, surgical pathology revealed undersigned-placenta size-18.5x15.0x2.0xcm weight: 517.5gm, shape: discoid, umbilical cord: length received two parts, attached portion 34.0cm separately submitted portion 14.0cm insertion ecentric 1.7cm from the margin, membranes insertion markedly disrupted however, attached portion on inserts marginally, appearance normal, fetal face: blue gray , partially green linged, and highly vascularized, maternal surface: two areas of fibrin deposition, 0.7 and 1.9cm ingreatst dimension.No depressed areas or attached blood clot is grossly identified.Parenchyma normal.Diagnosis: third trimester placenta with three vessel cord and chorioamniotlc membranes , without inflammation.On (b)(6) 2010, hysterosalpingogram revealed total bilateral occlusion, only left coil was implanted, but hsg showed that both tubes were occluded.On(b)(6) 2011, ultrasound antenatal screen revealed the size of the gestational sac was six weeks and four days.And the fetal pole was visible but there was no fetal heartbeat as previously seen, this patient was offered a dilation and curettage which she had chosen to proceed.Laparoscopic findings revealed normal adnexal structures, normal fallopian tubes, and the appendix was also found and seen to be normal.The uterus measured about 8 weeks in size.After completion of the procedure, repeat laparoscopy revealed no perforation of the uterus.Surgical pathology revealed container designation product of conception: the specimen consists of suction cup device containing a 5.0x4.5x3.0 cm aggregate of tan rubbery decidua and pailliferous non/hydropic, there was no fetal somatic tissue identified and representative sections are submitted in block a1.Diagnosis: uterine contents: - inflamed dec,dua ahd placental tissue with degenerative changes.On (b)(6) 2014, histologic examination was performed.Current weight: 186 lbs.Approximate weight at the time of essure placement: 179 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-nov-2018: pfs received:events depression and anxiety added.Concurrent condition added.Incident: no lot number or sample available for investigation.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 retrospective pregnancy case was reported by a lawyer and describes the occurrence of device breakage ("device breakage"), abortion spontaneous ("miscarriage/pregnancy (stillbirth or miscarriage)") and pregnancy with contraceptive device ("unexpected post-implant pregnancy") in a 26-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffect." the patient's past medical history included obesity, multigravida and parity 4 ((b)(6) 2001, (b)(6) 2005, (b)(6) 2006 and (b)(6) 2010).She did not allege that essure caused birth defects.Previously administered products included for an unreported indication: morphine.Past adverse reactions to the above products included hypersensitivity with morphine.Concurrent conditions included pap smear abnormal and inflammation.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, 1 day after insertion of essure, the patient experienced pelvic pain ("severe pelvic pain/pain").On (b)(6) 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with pelvic pain.On (b)(6) 2011, the patient experienced abortion spontaneous (seriousness criterion medically significant) with haemorrhage in pregnancy.In (b)(6) 2011, the patient experienced device breakage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding") and menorrhagia ("abnormal bleeding (menorrhagia)").In 2011, the patient experienced dysmenorrhoea ("dysmenorrhea").On an unknown date, the patient experienced complication of device insertion ("pregnancy (with complications)/coil was not able to be implanted into right fallopian tube").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (a suction d&c was performed).Essure treatment was not changed.At the time of the report, the device breakage, abortion spontaneous, pregnancy with contraceptive device, pelvic pain, complication of device insertion, vaginal haemorrhage, menorrhagia and dysmenorrhoea outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, complication of device insertion, device breakage, dysmenorrhoea, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 32.4 kg/sqm.Smear cervix - on (b)(6) 2014: inflammation.Ultrasound antenatal screen - on (b)(6) 2011: absent fetal heartbeat; in 2011: fetal heartbeat confirmed.On (b)(6) 2009, surgical pathology revealed undersigned-placenta size-18.5x15.0x2.0xcm weight: 517.5gm, shape: discoid, umbilical cord: length received two parts, attached portion 34.0cm separately submitted portion 14.0cm insertion excentric 1.7cm from the margin, membranes insertion markedly disrupted however, attached portion on inserts marginally, appearance normal, fetal face: blue gray , partially green linged, and highly vascularized, maternal surface: two areas of fibrin deposition, 0.7 and 1.9cm in greatest dimension.No depressed areas or attached blood clot is grossly identified.Parenchyma normal.Diagnosis: third trimester placenta with three vessel cord and chorioamniotic membranes, without inflammation.On (b)(6) 2010, hysterosalpingogram revealed total bilateral occlusion, only left coil was implanted, but hsg showed that both tubes were occluded.On (b)(6) 2011, ultrasound antenatal screen revealed the size of the gestational sac was six weeks and four days.And the fetal pole was visible but there was no fetal heartbeat as previously seen, this patient was offered a dilation and curettage which she had chosen to proceed.Laparoscopic findings revealed normal adnexal structures, normal fallopian tubes, and the appendix was also found and seen to be normal.The uterus measured about 8 weeks in size.After completion of the procedure, repeat laparoscopy revealed no perforation of the uterus.Surgical pathology revealed container designation product of conception: the specimen consists of suction cup device containing a 5.0x4.5x3.0 cm aggregate of tan rubbery decidua and pilliferous non/hydropic, there was no fetal somatic tissue identified and representative sections are submitted in block a1.Diagnosis: uterine contents: inflamed dec, dua ahd placental tissue with degenerative changes.On (b)(6) 2014, histologic examination was performed.Current weight: 186 lbs.Approximate weight at the time of essure placement: 179 lbs.Most recent follow-up information incorporated above includes: on 20-jun-2018: quality safety evaluation of product technical complaint.Incident: no lot number or sample available for investigation.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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage'), abortion spontaneous ('miscarriage/pregnancy (stillbirth or miscarriage)') and pregnancy with contraceptive device ('unexpected post-implant pregnancy') in a 26-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffect".The patient's medical history included obesity, multigravida and parity 4 ((b)(6) 2001,(b)(6) 2005, (b)(6) 2006 and (b)(6) 2010).She did not allege that essure caused birth defects.*on (b)(6) 2009, surgical pathology revealed undersigned-placenta size-18.5x15.0x2.0xcm weight: 517.5gm, shape: discoid, umbilical cord: length received two parts, attached portion 34.0cm separately submitted portion 14.0cm insertion ecentric 1.7cm from the margin, membranes insertion markedly disrupted however, attached portion on inserts marginally, appearance normal, fetal face: blue gray , partially green linged, and highly vascularized, maternal surface: two areas of fibrin deposition, 0.7 and 1.9cm ingreatst dimension.Nodepressed areas or attached blood clot is grossly identified.Parenchyma normal.Diagnosis: third trimester placenta with three vessel cord and chorioamniotlc membranes , without inflammation.On 27-aug-2010, hysterosalpingogram revealed total bilateral occlusion, only left coil was implanted, but hsg showed that both tubes were occluded.On (b)(6) 2011, ultrasound antenatal screenrevealed the size of the gestational sac was six weeks and four days.And the fetal pole was visible but there was no fetal heartbeat as previously seen, this patient was offered a dilation and curettage which she had chosen to proceed.Laparoscopic findings revealed normal adnexal structures, normal fallopian tubes, and the appendix was also found and seen to be normal.The uterus measured about 8 weeks in size.After completion of the procedure, repeat laparoscopy revealed no perforation of the uterus.Surgical pathology revealed container designation product of conception: thespecimen consists of suction cup devicecontaining a 5.0x4.5x3.0 cm aggregate of tan rubbery decidua and pailliferous non/hydropic, there was no fetal somatic tissue identified and representative sections are submitted in block a1.Diagnosis: uterine contents: - inflamed dec,dua ahd placental tissue with degenerative changes.On (b)(6) 2014, histologic examination was performed.Current weight: 186 lbs.Approximate weight at the time of essure placement: 179 lbs.Previously administered products included for an unreported indication: morphine.Past adverse reactions to the above products included hypersensitivity with morphine.Concurrent conditions included pap smear abnormal, inflammation and seizures.Concomitant products included gabapentin since 2016 and rivaroxaban (xarelto) since 2016.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced pelvic pain ("severe pelvic pain/pain"), 1 day after insertion of essure.On (b)(6) 2011, the patient experienced abortion spontaneous (seriousness criterion medically significant) with haemorrhage in pregnancy and was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) with pelvic pain.In march 2011, the patient experienced dysmenorrhoea ("dysmenorrhea").In may 2011, the patient experienced device breakage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding") and heavy menstrual bleeding ("abnormal bleeding (menorrhagia)").On an unknown date, the patient experienced complication of device insertion ("pregnancy (with complications)/coil was not able to be implanted into right fallopian tube"), depression ("depression") and anxiety ("mental anguish").The patient was treated with surgery (a suction d&c was performed).Essure treatment was not changed.At the time of the report, the device breakage, abortion spontaneous, pregnancy with contraceptive device, pelvic pain, complication of device insertion, vaginal haemorrhage, heavy menstrual bleeding, dysmenorrhoea, depression and anxiety outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 4.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, anxiety, complication of device insertion, depression, device breakage, dysmenorrhoea, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: 3-4 coils noted at left side.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.8 kg/sqm.Smear cervix - on (b)(6) 2014: results: inflammation.Ultrasound antenatal screen - on (b)(6) 2011: results: absent fetal heartbeat; in 2011: results: fetal heartbeat confirmed.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 13-may-2021: medical record received: case become a medically confirm.Rcc added.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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