| Model Number ESS305 |
| Device Problems
Break (1069); Difficult to Insert (1316); Separation Failure (2547); Activation, Positioning or Separation Problem (2906); Material Distortion (2977); Material Integrity Problem (2978)
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| Patient Problems
Abdominal Pain (1685); Pain (1994); Anxiety (2328); Discomfort (2330); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/01/2016 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain ("abdominal pain / pain") in an adult female patient who received essure.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device malfunction.On (b)(6) 2016, the patient started essure.On (b)(6) 2016, the same day after starting essure, the patient experienced device breakage ("the instrument (to remove insert) distorted the shape of the inserts and there was a break in the insert / the coil and the insert was partially still in the tube"), the first episode of device deployment issue ("the insert did not release"), the second episode of device deployment issue ("numerous attempts to release were done and with each attempt the insert became more dislodged and was pulled out, but could not be pulled out completely") and device difficult to use ("attempt to removal was unsuccessful").On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and clinically significant/ intervention required), complication of device insertion ("the left tubal ostea was not identified after 1 hour and procedure was abandoned"), anxiety, procedural pain ("persistent pain following attempt of essure insertion") and post procedural discomfort ("persistent discomfort following essure attempt insertion").The patient was treated with surgery (laparoscopic bilateral tubal salpingectomy / hysteroscopy with removal of essure coil on (b)(6) 2016).Essure was withdrawn.At the time of the report, the abdominal pain had not resolved and the device breakage, first episode of device deployment issue, second episode of device deployment issue, device difficult to use, complication of device insertion, anxiety, procedural pain and post procedural discomfort outcome was unknown.The reporter considered abdominal pain, device breakage, the first episode of device deployment issue, the second episode of device deployment issue, device difficult to use, complication of device insertion, anxiety, procedural pain and post procedural discomfort to be related to essure.The reporter commented: essure was placed under general endotracheal anesthesia.Notably, the operative report only states that 1 small single coil of essure was removed, and this was located in the endometrial canal.The pathology report does not mention essure coil.Company causality comment: this spontaneous case report refers to a female consumer who experienced abdominal pain / pain.It was also reported that consumer experienced problems during essure insertion and that the instrument (to remove insert) distorted the shape of the inserts and there was a break in the insert / the coil and the insert was partially still in the tube (seen as device breakage), amongst other non-serious events.Consumer underwent a laparoscopic bilateral tubal salpingectomy / hysteroscopy with removal of essure coil, about three months after essure insertion.Abdominal pain is anticipated in the reference safety information for essure.Abdominal pain could be alternatively explained by the remaining coil in the tube, however, as it may occur during essure wearing, a causal relationship with essure cannot be excluded.This case was regarded as incident, as a surgical intervention was required.A product technical analysis is expected.Further information will be obtained through the litigation process.
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Manufacturer Narrative
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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 or 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.The possibility of a detachment difficulty event and micro-insert breaking are anticipated events and there were no events reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the provided information the defect type corresponds to the following meddra llt: device breakage and device malfunction.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events 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 (b)(6) 2017: quality-safety evaluation of ptc company causality comment: this spontaneous case report refers to a female consumer who experienced abdominal pain / pain.It was also reported that consumer experienced problems during essure insertion and that the instrument (to remove insert) distorted the shape of the inserts and there was a break in the insert / the coil and the insert was partially still in the tube (seen as device breakage), amongst other non-serious events.Consumer underwent a laparoscopic bilateral tubal salpingectomy / hysteroscopy with removal of essure coil, about three months after essure insertion.The events are anticipated in the reference safety information for essure.Abdominal pain could be alternatively explained by the remaining coil in the tube, however, as it may occur during essure wearing.The device breakage occurred during essure insertion procedure.Based on the information provided, a causal relationship between the events with essure cannot be excluded.This case was regarded as incident, as a surgical intervention was required.According to the product technical analysis, a product quality defect could not be confirmed but is considered plausible.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 device breakage ('the instrument (to remove insert) distorted the shape of the inserts and there was a break in the insert / the coil and the insert was partially still in the tube') and abdominal pain ('abdominal pain / pain') in a 44-year-old female patient who had essure (batch no.D08068-inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "the insert did not release" on (b)(6) 2016, device placement issue "numerous attempts to release were done and with each attempt the insert became more dislodged and was pulled out, but could not be pulled out completely" on (b)(6) 2016 and device malfunction "device malfunction".The patient's medical history included insomnia, anxiety, gastritis, overactive bladder, post-traumatic stress disorder, vitamin d deficiency, neck pain, ovarian cyst, copd, tobacco abuse, paratubal cyst and uterine fibroids.On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("attempt to removal was unsuccessful").On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), complication of device insertion ("the left tubal ostea was not identified after 1 hour and procedure was abandoned"), anxiety ("anxiety"), procedural pain ("persistent pain following attempt of essure insertion") and post procedural discomfort ("persistent discomfort following essure attempt insertion").The patient was treated with surgery (laparoscopic bilateral tubal salpingectomy / hysteroscopy with removal of essure coil on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, complication of device removal, complication of device insertion, anxiety, procedural pain and post procedural discomfort outcome was unknown and the abdominal pain had not resolved.The reporter considered abdominal pain, anxiety, complication of device insertion, complication of device removal, device breakage, post procedural discomfort and procedural pain to be related to essure.The reporter commented: essure was placed under general endotracheal anesthesia.Notably, the operative report only states that 1 small single coil of essure was removed, and this was located in the endometrial canal.The pathology report does not mention essure coil.Essure partially inserted right side ,left side not attempted.Essure not expelled into tube perfectly.Right tube could not be cannulated properly.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 or 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.The possibility of a detachment difficulty event and micro-insert breaking are anticipated events and there were no events reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the provided information the defect type corresponds to the following meddra llt: device breakage and device malfunction.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events 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 18-aug-2020: update of information (batch is not valid).Based on the available information, a review of our complaint records and other relevant data will be 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 ('the instrument (to remove insert) distorted the shape of the inserts and there was a break in the insert / the coil and the insert was partially still in the tube') and abdominal pain ('abdominal pain / pain') in a 44-year-old female patient who had essure (batch no.D08068-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "the insert did not release" on (b)(6) 2016, device placement issue "numerous attempts to release were done and with each attempt the insert became more dislodged and was pulled out, but could not be pulled out completely" on (b)(6) 2016 and device malfunction "device malfunction".The patient's medical history included insomnia, anxiety, gastritis, overactive bladder, post-traumatic stress disorder, vitamin d deficiency, neck pain, ovarian cyst, copd, tobacco abuse, paratubal cyst and uterine fibroids.On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("attempt to removal was unsuccessful").On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), complication of device insertion ("the left tubal ostea was not identified after 1 hour and procedure was abandoned"), anxiety ("anxiety"), procedural pain ("persistent pain following attempt of essure insertion") and post procedural discomfort ("persistent discomfort following essure attempt insertion").The patient was treated with surgery (laparoscopic bilateral tubal salpingectomy / hysteroscopy with removal of essure coil on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, complication of device removal, complication of device insertion, anxiety, procedural pain and post procedural discomfort outcome was unknown and the abdominal pain had not resolved.The reporter considered abdominal pain, anxiety, complication of device insertion, complication of device removal, device breakage, post procedural discomfort and procedural pain to be related to essure.The reporter commented: essure was placed under general endotracheal anestesia.Notably, the operative report only states that 1 small single coil of essure was removed, and this was located in the endometrial canal.The pathology report does not mention essure coil.Essure partially inserted right side ,left side not attempted.Essure not expelled into tube perfectly.Right tube could not be cannulated properly.Lot number reported (d08068 ) is not valid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-aug-2020: 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 ('the instrument (to remove insert) distorted the shape of the inserts and there was a break in the insert / the coil and the insert was partially still in the tube') and abdominal pain ('abdominal pain / pain') in a 44-year-old female patient who had essure (batch no.D08068) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "the insert did not release" on (b)(6) 2016, device placement issue "numerous attempts to release were done and with each attempt the insert became more dislodged and was pulled out, but could not be pulled out completely" on (b)(6) 2016 and device malfunction "device malfunction".The patient's medical history included insomnia, anxiety, gastritis, overactive bladder, post-traumatic stress disorder, vitamin d deficiency, neck pain, ovarian cyst, copd, tobacco abuse, paratubal cyst and uterine fibroids.On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("attempt to removal was unsuccessful").On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), complication of device insertion ("the left tubal ostea was not identified after 1 hour and procedure was abandoned"), anxiety ("anxiety"), procedural pain ("persistent pain following attempt of essure insertion") and post procedural discomfort ("persistent discomfort following essure attempt insertion").The patient was treated with surgery (laparoscopic bilateral tubal salpingectomy / hysteroscopy with removal of essure coil on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, complication of device removal, complication of device insertion, anxiety, procedural pain and post procedural discomfort outcome was unknown and the abdominal pain had not resolved.The reporter considered abdominal pain, anxiety, complication of device insertion, complication of device removal, device breakage, post procedural discomfort and procedural pain to be related to essure.The reporter commented: essure was placed under general endotracheal anesthesia.Notably, the operative report only states that 1 small single coil of essure was removed, and this was located in the endometrial canal.The pathology report does not mention essure coil.Essure partially inserted right side ,left side not attempted.Essure not expelled into tube perfectly.Right tube could not be cannulated properly.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 or 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.The possibility of a detachment difficulty event and micro-insert breaking are anticipated events and there were no events reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the provided information the defect type corresponds to the following meddra llt: device breakage and device malfunction.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events 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 3-aug-2020: mr received: lot number were added and reporter information were updated.Device breakage upgraded to incident.We received a lot number in this case.A technical investigation will be 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('the instrument (to remove insert) distorted the shape of the inserts and there was a break in the insert / the coil and the insert was partially still in the tube') and abdominal pain ('abdominal pain / pain') in a 44-year-old female patient who had essure (batch no.D08068-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device placement issue "numerous attempts to release were done and with each attempt the insert became more dislodged and was pulled out, but could not be pulled out completely" on (b)(6) 2016, device deployment issue "the insert did not release" on (b)(6) 2016 and device malfunction "device malfunction".The patient's medical history included insomnia, anxiety, gastritis, overactive bladder, post-traumatic stress disorder, vitamin d deficiency, neck pain, ovarian cyst, copd, tobacco abuse, paratubal cyst and uterine fibroids.On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("attempt to removal was unsuccessful").On an unknown date, the patient experienced device dislocation ("migration"), abdominal pain (seriousness criteria medically significant and intervention required), complication of device insertion ("the left tubal ostea was not identified after 1 hour and procedure was abandoned"), anxiety ("anxiety"), procedural pain ("persistent pain following attempt of essure insertion"), post procedural discomfort ("persistent discomfort following essure attempt insertion"), genital haemorrhage ("abnormal bleeding"), anaemia ("anemia") and pelvic pain ("pain").The patient was treated with surgery (laparoscopic bilateral tubal salpingectomy / hysteroscopy with removal of essure coil on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, device dislocation, complication of device removal, complication of device insertion, anxiety, procedural pain, post procedural discomfort, genital hemorrhage, anaemia and pelvic pain outcome was unknown and the abdominal pain had not resolved.The reporter considered abdominal pain, anaemia, anxiety, complication of device insertion, complication of device removal, device breakage, device dislocation, genital hemorrhage, pelvic pain, post procedural discomfort and procedural pain to be related to essure.The reporter commented: essure was placed under general endotracheal anestesia.Notably, the operative report only states that 1 small single coil of essure was removed, and this was located in the endometrial canal.The pathology report does not mention essure coil.Essure partially inserted right side ,left side not attempted.Essure not expelled into tube perfectly.Right tube could not be cannulated properly.The essure coil implanted in her right tube was only partially implanted due to a malfunction.The physician could not get it out after it was partially implanted, despite attempts to "unscrew" it and pull it out.Lot number reported (d08068 ) is not valid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-aug-2020: pif received: events migration, abnormal bleeding, anemia, pelvic pain female were 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('the instrument (to remove insert) distorted the shape of the inserts and there was a break in the insert / the coil and the insert was partially still in the tube') and abdominal pain ('abdominal pain / pain') in a 44-year-old female patient who had essure (batch no.D08068-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "the insert did not release" on (b)(6) 2016, device placement issue "numerous attempts to release were done and with each attempt the insert became more dislodged and was pulled out, but could not be pulled out completely" on (b)(6) 2016 and device malfunction "device malfunction".The patient's medical history included insomnia, anxiety, gastritis, overactive bladder, post-traumatic stress disorder, vitamin d deficiency, neck pain, ovarian cyst, copd, tobacco abuse, paratubal cyst, uterine fibroids, hyperlipidemia, allergic rhinitis, gerd, hot flashes, menopause, depression, inappropriate diet, post-traumatic pain, cough, headache, nasal congestion, productive cough, cigarette smoker, respiratory tract congestion, wheezing, heartburn, nausea, dyslipidemia, seasonal allergy, pain in heel, overweight, respiratory tract infection, tooth extraction, irritable bowel syndrome, epigastric pain and pelvic adhesions.On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("attempt to removal was unsuccessful").On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), device dislocation ("migration"), pelvic pain ("pain"), complication of device insertion ("the left tubal ostea was not identified after 1 hour and procedure was abandoned"), anxiety ("anxiety"), procedural pain ("persistent pain following attempt of essure insertion"), post procedural discomfort ("persistent discomfort following essure attempt insertion"), genital haemorrhage ("abnormal bleeding") and anaemia ("anemia").The patient was treated with surgery (laparoscopic bilateral tubal salpingectomy / hysteroscopy with removal of essure coil on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, device dislocation, pelvic pain, complication of device removal, complication of device insertion, anxiety, procedural pain, post procedural discomfort, genital haemorrhage and anaemia outcome was unknown and the abdominal pain had not resolved.The reporter considered abdominal pain, anaemia, anxiety, complication of device insertion, complication of device removal, device breakage, device dislocation, genital haemorrhage, pelvic pain, post procedural discomfort and procedural pain to be related to essure.The reporter commented: essure removal date as per mr (b)(6) 2017.Essure was placed under general endotracheal anestesia.Notably, the operative report only states that 1 small single coil of essure was removed, and this was located in the endometrial canal.The pathology report does not mention essure coil.Essure partially inserted right side ,left side not attempted.Essure not expelled into tube perfectly.Right tube could not be cannulated properly.The essure coil implanted in her right tube was only partially implanted due to a malfunction.The physician could not get it out after it was partially implanted, despite attempts to "unscrew" it and pull it out.Date of procedure-(b)(6) 2016: tubal sterilization with bilateral salpingectomy, and removal of coil.Date of procedure-(b)(6) 2017: procedures performed: laparoscopic-assisted vaginal hysterectomy converted to a total abdominal hysterectomy and bilateral salpingectomy.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - on (b)(6) 2015: the left ovarian cyst measuring 1.5 cm size, otherwise no abnormality seen.There is minimal fluid noted in the cervix and there is a cystic structure noted which probably represents nabothian cyst.Lot number reported (d08068 ) is not valid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-jun-2021: mr received: medical history and rcc added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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