| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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| Patient Problems
Hair Loss (1877); Headache (1880); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Uterine Perforation (2121); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 09/28/2016 |
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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 embedded device ("right coil was protruding into the endometrium/ right coil was embedded in the endometrium") and pelvic pain ("pelvic pain/ sharp pain with walking") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure, plaintiff menstrual cycles were three to four days, normal and regular.Concurrent conditions included allergy to metals.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2016, 8 years 8 months after insertion of essure, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant), menometrorrhagia ("heavy and irregular periods with blood clots"), polymenorrhoea ("at times periods as frequent as every two and a half weeks"), migraine ("migraine"), alopecia ("significant hair loss"), rash ("rashes") and dyspareunia ("dyspareunia/ sharp pain with intercourse").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the embedded device, pelvic pain, menometrorrhagia, polymenorrhoea, alopecia, rash and dyspareunia had resolved and the migraine had not resolved.The reporter considered alopecia, dyspareunia, embedded device, menometrorrhagia, migraine, pelvic pain, polymenorrhoea and rash to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis.On (b)(6) 2016: right coil protruding into the endometrium.Company causality comment: this litigation case report refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2008 and experienced adverse events, including pelvic pain and right coil was protruding into the endometrium/ right coil was embedded in the endometrium.She was submitted to a laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy on (b)(6) 2016.Pelvic pain may occur after essure insertion.In this particular case pelvic pain could also be related to the embedment of device in the endometrium.During essure micro-insert therapy, there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body), dislocation (distal fallopian tube or peritoneal cavity) or occur as a result of uterine perforation, mainly during insertion.In this case, the exact date and the mechanism of the embedment are not known.The case was classified as incident since device removal was required.A product technical analysis is being sought.Follow-up 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 embedded device ("right coil was protruding into the endometrium/ right coil was embedded in the endometrium") and pelvic pain ("pelvic pain/ sharp pain with walking") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure, plaintiff menstrual cycles were three to four days, normal and regular.Concurrent conditions included dermatitis due to metals.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2016, 8 years 8 months after insertion of essure, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant), menometrorrhagia ("heavy and irregular periods with blood clots"), polymenorrhoea ("at times periods as frequent as every two and a half weeks"), migraine ("migraine"), alopecia ("significant hair loss"), rash ("rashes") and dyspareunia ("dyspareunia/ sharp pain with intercourse").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the embedded device, pelvic pain, menometrorrhagia, polymenorrhoea, alopecia, rash and dyspareunia had resolved and the migraine had not resolved.The reporter considered alopecia, dyspareunia, embedded device, menometrorrhagia, migraine, pelvic pain, polymenorrhoea and rash to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2016: right coil protruding into the endometrium.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 available information, a product quality defect could not be confirmed but is considered plausible.A relationship between the reported medical events and a quality defect cannot be totally excluded.However, 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 cannot be evaluated.Most recent follow-up information incorporated above includes: on 27-apr-2017: quality safety evaluation of product technical complaint.Company causality comment: this litigation case report refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2008 and experienced adverse events, including pelvic pain and right coil was protruding into the endometrium/ right coil was embedded in the endometrium.She was submitted to a laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy on (b)(6) 2016.Pelvic pain may occur after essure insertion.In this particular case pelvic pain could also be related to the embedment of device in the endometrium.During essure micro-insert therapy, there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body), dislocation (distal fallopian tube or peritoneal cavity) or occur as a result of uterine perforation, mainly during insertion.In this case, the exact date and the mechanism of the embedment are not known.The case was classified as incident since device removal was required.Based on the available information, a product quality defect could not be confirmed but is considered plausible.A relationship between the reported medical events and a quality defect cannot be totally excluded.However, 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 cannot be evaluated.Follow-up 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 uterine perforation ('perforation'), embedded device ('right coil was protruding into the endometrium/ right coil was embedded in the endometrium') and device dislocation ('migration') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure, plaintiff menstrual cycles were three to four days, normal and regular.Concurrent conditions included dermatitis due to metals.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required), 8 years 8 months after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain/ sharp pain with walking"), menometrorrhagia ("heavy and irregular periods with blood clots"), polymenorrhoea ("at times periods as frequent as every two and a half weeks"), migraine ("migraine"), alopecia ("significant hair loss"), rash ("rashes"), dyspareunia ("dyspareunia/ sharp pain with intercourse"), headache ("headache") and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, device dislocation, headache and genital haemorrhage outcome was unknown, the embedded device, pelvic pain, menometrorrhagia, polymenorrhoea, alopecia, rash and dyspareunia had resolved and the migraine had not resolved.The reporter considered alopecia, device dislocation, dyspareunia, embedded device, genital haemorrhage, headache, menometrorrhagia, migraine, pelvic pain, polymenorrhoea, rash and uterine perforation to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2016: results: right coil protruding into the endometrium.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-sep-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 uterine perforation ('perforation'), embedded device ('right coil was protruding into the endometrium/ right coil was embedded in the endometrium') and device dislocation ('migration') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure, plaintiff menstrual cycles were three to four days, normal and regular.Concurrent conditions included dermatitis due to metals.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required), 8 years 8 months after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain/ sharp pain with walking"), menometrorrhagia ("heavy and irregular periods with blood clots"), polymenorrhoea ("at times periods as frequent as every two and a half weeks"), migraine ("migraine"), alopecia ("significant hair loss"), rash ("rashes"), dyspareunia ("dyspareunia/ sharp pain with intercourse"), headache ("headache") and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, device dislocation, headache and genital haemorrhage outcome was unknown, the embedded device, pelvic pain, menometrorrhagia, polymenorrhoea, alopecia, rash and dyspareunia had resolved and the migraine had not resolved.The reporter considered alopecia, device dislocation, dyspareunia, embedded device, genital haemorrhage, headache, menometrorrhagia, migraine, pelvic pain, polymenorrhoea, rash and uterine perforation to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2016: results: right coil protruding into the endometrium.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 available information, a product quality defect could not be confirmed but is considered plausible.A relationship between the reported medical events and a quality defect cannot be totally excluded.However, 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 cannot be evaluated.Most recent follow-up information incorporated above includes: on 28-aug-2020: pif received.New events- genital haemorrhage, perforation, device migration, headache 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('perforation'), embedded device ('right coil was protruding into the endometrium/ right coil was embedded in the endometrium, essure coils in the endometrium') and device dislocation ('migration') in a 43-year-old female patient who had essure (batch no.624847) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure, plaintiff menstrual cycles were three to four days, normal and regular.Concurrent conditions included dermatitis due to metals.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required), 8 years 8 months after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain/ sharp pain with walking"), menometrorrhagia ("heavy and irregular periods with blood clots"), polymenorrhoea ("at times periods as frequent as every two and a half weeks"), migraine ("migraine"), alopecia ("significant hair loss"), rash ("rashes"), dyspareunia ("dyspareunia/ sharp pain with intercourse"), headache ("headache") and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, device dislocation, headache and genital haemorrhage outcome was unknown, the embedded device, pelvic pain, menometrorrhagia, polymenorrhoea, alopecia, rash and dyspareunia had resolved and the migraine had not resolved.The reporter considered alopecia, device dislocation, dyspareunia, embedded device, genital haemorrhage, headache, menometrorrhagia, migraine, pelvic pain, polymenorrhoea, rash and uterine perforation to be related to essure.The reporter commented: right: 6 coils, left: 3 coils.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2016: results: right coil protruding into the endometrium.Lot number: 624847 manufacturing date: 2007-07 expiration date: 2009-06.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, essure coils in the endometrium.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 23-jun-2021: quality safety evaluation of ptc.We received a lot number in this case.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('perforation'), embedded device ('right coil was protruding into the endometrium/ right coil was embedded in the endometrium, essure coils in the endometrium') and device dislocation ('migration') in a 43-year-old female patient who had essure (batch no.624847) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: prior to essure, plaintiff menstrual cycles were three to four days, normal and regular.Concurrent conditions included dermatitis due to metals.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required), 8 years 8 months after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain/ sharp pain with walking"), menometrorrhagia ("heavy and irregular periods with blood clots"), polymenorrhoea ("at times periods as frequent as every two and a half weeks"), migraine ("migraine"), alopecia ("significant hair loss"), rash ("rashes"), dyspareunia ("dyspareunia/ sharp pain with intercourse"), headache ("headache") and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy with bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, device dislocation, headache and genital haemorrhage outcome was unknown, the embedded device, pelvic pain, menometrorrhagia, polymenorrhoea, alopecia, rash and dyspareunia had resolved and the migraine had not resolved.The reporter considered alopecia, device dislocation, dyspareunia, embedded device, genital haemorrhage, headache, menometrorrhagia, migraine, pelvic pain, polymenorrhoea, rash and uterine perforation to be related to essure.The reporter commented: right: 6 coils, left: 3 coils.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2016: results: right coil protruding into the endometrium.Lot number: 624847.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, essure coils in the endometrium.Most recent follow-up information incorporated above includes: on 15-jun-2021: mr received.Reporter information, patient middle name, dob, product indication, lot number, rcc added.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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