| Model Number ESS305 |
| Device Problems
Break (1069); Material Fragmentation (1261); Insufficient Information (3190); Migration (4003)
|
| Patient Problems
Pain (1994); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
|
| Event Date 10/15/2009 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragmentation of the device") and embedded device ("uterine tissue fragments were found to be containing pieces of metal wire") in a female patient who received essure for contraception.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient started essure.In 2009, the patient experienced device breakage (seriousness criteria medically significant and clinically significant/intervention required) with pelvic pain and embedded device (seriousness criteria medically significant and clinically significant/intervention required).On an unknown date, the patient experienced menorrhagia ("menorrhagia").The patient was treated with surgery (on (b)(6) 2009 essure device removal via hysterectomy).Essure was withdrawn.At the time of the report, the device breakage, embedded device and menorrhagia outcome was unknown.The reporter considered device breakage, embedded device and menorrhagia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): on (b)(6) 2009: x-ray result was showed essure device was properly in place.Company causality comment: this spontaneous legal case report refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted and experienced device breakage ("fragmentation of the device") and embedded device ("uterine tissue fragments were found to be containing pieces of metal wire").A hysterectomy was performed to remove essure.Device breakage and embedded device are anticipated events according to reference safety information for essure.The exact time point and mechanism of device breakage and embedded device are not known, however, considering their nature, a causal relationship between these events and essure cannot be excluded.This case was regarded as incident, since surgical intervention was required.A product technical complaint analysis is being sought.Further information will be obtained through the litigation process.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragmentation of the device") and embedded device ("uterine tissue fragments were found to be containing pieces of metal wire") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with pelvic pain and embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced menorrhagia ("menorrhagia").The patient was treated with surgery (on (b)(6) 2009 essure device removal via hysterectomy) and surgery (on (b)(6) 2009 essure device removal via hysterectomy).Essure was removed on (b)(6) 2009.At the time of the report, the device breakage, embedded device and menorrhagia outcome was unknown.The reporter considered device breakage, embedded device and menorrhagia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on (b)(6) 2009: showed essure device was properly in place.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 were 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.The possibility micro-insert breaking is an anticipated event and there was no event 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.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and 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 6-apr-2017: quality safety evaluation received.Company causality comment: this spontaneous legal case report refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted and experienced device breakage ("fragmentation of the device") and embedded device ("uterine tissue fragments were found to be containing pieces of metal wire").A hysterectomy was performed to remove essure.Device breakage and embedded device are anticipated events according to reference safety information for essure.The exact time point and mechanism of device breakage and embedded device are not known, however, considering their nature, a causal relationship between these events and essure cannot be excluded.This case was regarded as incident, since surgical intervention was required.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and 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 further information will be obtained through the litigation process.
|
| |
|
Manufacturer Narrative
|
|
Spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragmentation of the device/fracture") and uterine perforation ("uterine tissue fragments were found to be containing pieces of metal wire/migration of essure device/perforation (uterus)") in a (b)(6)-year-old female patient who had essure (batch no.623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included anxiety, depression, bundle branch block left, cholecystectomy in 2000, appendectomy and cesarean section (times 5 a number of years ago).Concurrent conditions included abdominal pain, offensive vaginal discharge, menometrorrhagia, smoker, hematocrit decreased, adenomyosis and cholecystectomy since 2000.Concomitant products included medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, 3 months 11 days after insertion of essure, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2009, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with pelvic pain and uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced menorrhagia ("menorrhagia/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("mental anguish") and back pain ("lower back pain").The patient was treated with surgery (on (b)(6) 2009 essure device removal via hysterectomy/supracervical hysterectomy(uterus)) and surgery (on (b)(6) 2009 essure device removal via hysterectomy(partial)/supracervical hysterectomy(uterus)).Essure was removed on (b)(6) 2009.At the time of the report, the device breakage, uterine perforation, menorrhagia, vaginal haemorrhage, dysmenorrhoea, depression, anxiety and back pain outcome was unknown.The reporter considered anxiety, back pain, depression, device breakage, dysmenorrhoea, menorrhagia, uterine perforation and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion.X-ray - on (b)(6) 2009: showed essure device was properly in place.Most recent follow-up information incorporated above includes: on 3-oct-2018: new pfs received- new events added: lower back pain, depression,mental anguish were added.Incident.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragmentation of the device/fracture") and uterine perforation ("uterine tissue fragments were found to be containing pieces of metal wire/migration of essure device/perforation (uterus)") in a 44-year-old female patient who had essure (batch no.623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, 4 months 25 days after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with pelvic pain and uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced menorrhagia ("menorrhagia/abnormal bleeding (vaginal, menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").The patient was treated with surgery (on (b)(6) 2009 essure device removal via hysterectomy/supracervical hysterectomy(uterus)) and surgery (on (b)(6) 2009 essure device removal via hysterectomy(partial)/supracervical hysterectomy(uterus)).Essure was removed on (b)(6) 2009.At the time of the report, the device breakage, uterine perforation, menorrhagia and vaginal haemorrhage outcome was unknown.The reporter considered device breakage, menorrhagia, uterine perforation and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion.X-ray - on (b)(6) 2009: showed essure device was properly in place.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet: new reporter was added, patient demographic details added, lab data added, product indication added, product lot number added.Event was clubbed: menorrhagia/abnormal bleeding (vaginal, menorrhagia), fragmentation of the device/fracture.Event was added: vaginal bleeding.Event was updated: uterine tissue fragments were found to be containing pieces of metal wire/migration of essure device/perforation (uterus), pt changed from embedded device to uterine perforation.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragmentation of the device/fracture") and uterine perforation ("uterine tissue fragments were found to be containing pieces of metal wire/migration of essure device/perforation (uterus)") in a 44-year-old female patient who had essure (batch no: 623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included anxiety, depression, bundle branch block left, cholecystectomy in 2000, appendectomy and cesarean section (times 5 a number of years ago).Concurrent conditions included abdominal pain, offensive vaginal discharge, menometrorrhagia, smoker, hematocrit decreased, adenomyosis and cholecystectomy since 2000.Concomitant products included medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since may 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), 3 months 11 days after insertion of essure.On (b)(6) 2009, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with pelvic pain and uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced menorrhagia ("menorrhagia/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("mental anguish") and back pain ("lower back pain").The patient was treated with surgery (on (b)(6) 2009 essure device removal via hysterectomy(partial)/supracervical hysterectomy(uterus) and on (b)(6) 2009 essure device removal via hysterectomy/supracervical hysterectomy(uterus)).Essure was removed on (b)(6) 2009.At the time of the report, the device breakage, uterine perforation, menorrhagia, vaginal haemorrhage, dysmenorrhoea, depression and anxiety outcome was unknown and the back pain was resolving.The reporter considered anxiety, back pain, depression, device breakage, dysmenorrhoea, menorrhagia, uterine perforation and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on (b)(6) 2009: results: total bilateral occlusion.X-ray: on (b)(6) 2009: results: showed essure device was properly in place.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-dec-2018: pfs received.Updated outcome of event(back pain).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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragmentation of the device/fracture") and uterine perforation ("uterine tissue fragments were found to be containing pieces of metal wire/migration of essure device/perforation (uterus)") in a 43-year-old female patient who had essure (batch no.623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included anxiety, depression, bundle branch block left, cholecystectomy in 2000, appendectomy, cesarean section (times 5 a number of years ago), miscarriage, vaginal bleeding and menorrhagia.Concurrent conditions included abdominal pain, offensive vaginal discharge, menometrorrhagia, smoker, hematocrit decreased, adenomyosis, cholecystectomy since 2000 and obesity.Concomitant products included medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced menorrhagia ("menorrhagia/abnormal bleeding (vaginal, menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").On (b)(6) 2009, the patient experienced depression ("psychological or psychiatric problems condition: depression") and anxiety ("mental anguish"), 1 month after insertion of essure.On (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2009, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with pelvic pain and uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced back pain ("lower back pain") and abdominal pain ("abdominal area pain").The patient was treated with nsaids and surgery (on (b)(6) 2009 essure device removal via hysterectomy(partial)/supracervical hysterectomy(uterus) and on (b)(6) 2009 essure device removal via hysterectomy/supracervical hysterectomy(uterus)).Essure was removed on (b)(6) 2009.At the time of the report, the device breakage, uterine perforation, dysmenorrhoea, depression and anxiety outcome was unknown and the menorrhagia, vaginal haemorrhage, back pain and abdominal pain had resolved.The reporter considered abdominal pain, anxiety, back pain, depression, device breakage, dysmenorrhoea, menorrhagia, uterine perforation and vaginal haemorrhage to be related to essure.The reporter commented: discrepancy noted in essure removal.As per (b)(6) 2019 fu she is not currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 33.6 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: results: total bilateral occlusion.X-ray - on (b)(6) 2009: results: showed essure device was properly in place.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received.Event added: abdominal pain.Outcome of event abdominal pain was updated.Medical history and treatment drug was added.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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragmentation of the device/fracture") and uterine perforation ("uterine tissue fragments were found to be containing pieces of metal wire/migration of essure device/perforation (uterus)") in a 44-year-old female patient who had essure (batch no.623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included anxiety, depression, bundle branch block left, cholecystectomy in 2000, appendectomy and cesarean section (times 5 a number of years ago).Concurrent conditions included abdominal pain, offensive vaginal discharge, menometrorrhagia, smoker, hematocrit decreased, adenomyosis and cholecystectomy since 2000.Concomitant products included medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since may 2009.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)") and dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2009, 4 months 25 days after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with pelvic pain and uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced menorrhagia ("menorrhagia/abnormal bleeding (vaginal, menorrhagia)").The patient was treated with surgery (on (b)(6) 2009 essure device removal via hysterectomy/supracervical hysterectomy(uterus)) and surgery (on (b)(6) 2009 essure device removal via hysterectomy(partial)/supracervical hysterectomy(uterus)).Essure was removed on (b)(6) 2009.At the time of the report, the device breakage, uterine perforation, menorrhagia, vaginal haemorrhage and dysmenorrhoea outcome was unknown.The reporter considered device breakage, dysmenorrhoea, menorrhagia, uterine perforation and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on 26-aug-2009: total bilateral occlusion x-ray - on 26-aug-2009: showed essure device was properly in place.Most recent follow-up information incorporated above includes: on 3-jul-2018: from pfs event " dysmenorrhea (cramping)" is added.Patient information and concomitant drug are added.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
|
| |
|
Manufacturer Narrative
|
|
Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragmentation of the device/fracture") and uterine perforation ("uterine tissue fragments were found to be containing pieces of metal wire/migration of essure device/perforation (uterus)") in a 44-year-old female patient who had essure (batch no.623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included anxiety, depression, bundle branch block left, cholecystectomy in 2000, appendectomy and cesarean section (times 5 a number of years ago).Concurrent conditions included abdominal pain, offensive vaginal discharge, menometrorrhagia, smoker, hematocrit decreased, adenomyosis and cholecystectomy since 2000.Concomitant products included medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, 3 months 11 days after insertion of essure, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2009, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with pelvic pain and uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced menorrhagia ("menorrhagia/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("mental anguish") and back pain ("lower back pain").The patient was treated with surgery (on (b)(6) 2009 essure device removal via hysterectomy/supracervical hysterectomy(uterus)) and surgery (on (b)(6) 2009 essure device removal via hysterectomy(partial)/supracervical hysterectomy(uterus)).Essure was removed on (b)(6) 2009.At the time of the report, the device breakage, uterine perforation, menorrhagia, vaginal haemorrhage, dysmenorrhoea, depression, anxiety and back pain outcome was unknown.The reporter considered anxiety, back pain, depression, device breakage, dysmenorrhoea, menorrhagia, uterine perforation and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion.X-ray - on (b)(6) 2009: showed essure device was properly in place.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 24-oct-2018: quality safety evaluation of ptc.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragmentation of the device/fracture") and uterine perforation ("uterine tissue fragments were found to be containing pieces of metal wire/migration of essure device/perforation (uterus)") in a 43-year-old female patient who had essure (batch no.623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included anxiety, depression, bundle branch block left, cholecystectomy in 2000, appendectomy, cesarean section (times 5 a number of years ago) and miscarriage.Concurrent conditions included abdominal pain, offensive vaginal discharge, menometrorrhagia, smoker, hematocrit decreased, adenomyosis, cholecystectomy since 2000 and obesity.Concomitant products included medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced depression ("psychological or psychiatric problems condition: depression") and anxiety ("mental anguish"), 1 month after insertion of essure.On (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2009, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with pelvic pain and uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced menorrhagia ("menorrhagia/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)") and back pain ("lower back pain").The patient was treated with surgery (on (b)(6) 2009 essure device removal via supracervical hysterectomy(uterus).Essure was removed on (b)(6) 2009.At the time of the report, the device breakage, uterine perforation, dysmenorrhoea, depression and anxiety outcome was unknown and the menorrhagia, vaginal haemorrhage and back pain had resolved.The reporter considered anxiety, back pain, depression, device breakage, dysmenorrhoea, menorrhagia, uterine perforation and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 33.6 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: results: total bilateral occlusion.X-ray - on (b)(6) 2009: results: showed essure device was properly in place.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received.Historical condition added.Event lower back pain, abnormal bleeding (vaginal, menorrhagia) outcome updated.New reporter added.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 non-conformance's data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
|
| |
|
Search Alerts/Recalls
|
|
