MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Anemia (1706); Uterine Perforation (2121); Fallopian Tube Perforation (4506); Genital Bleeding (4507)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('perforation: uterus / migration'), fallopian tube perforation ('perforation: fallopian tubes/migration'), genital haemorrhage ('bleeding: gen.Abnormal.Bleed') and blood loss anaemia ('bleeding: other anemia') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("pain: dysmennorhea (cramping)"), pelvic pain ("pain: pelvic/ severe pain in pelvic area"), abdominal pain ("pain: abdominal"), back pain ("pain:back"), dyspareunia ("pain: dyspareunia (painful sexual intercourse)"), menorrhagia ("bleeding: menorrhagia (heavy menstrual bleeding)"), blood loss anaemia (seriousness criterion medically significant), metrorrhagia ("bleeding: metorhagia (bleeding b/w periods)"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), vaginal infection ("vaginal.Infection"), vaginal discharge ("vaginal.Discharge"), fatigue ("fatigue"), nervous system disorder ("nuero condit/problem") and feeling abnormal ("brain fog") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (salpingectomy (bilateral) and hysterectomy (partial) and salpingectomy.(bilateral},hysterectomy.(partial)).Essure was removed on (b)(6) 2018.At the time of the report, the uterine perforation, fallopian tube perforation, genital haemorrhage, dysmenorrhoea, pelvic pain, abdominal pain, back pain, dyspareunia, menorrhagia, blood loss anaemia, metrorrhagia, bladder disorder, urinary tract disorder, vaginal infection, vaginal discharge, fatigue, hormone level abnormal, nervous system disorder and feeling abnormal outcome was unknown.The reporter considered abdominal pain, back pain, bladder disorder, blood loss anaemia, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, hormone level abnormal, menorrhagia, metrorrhagia, nervous system disorder, pelvic pain, urinary tract disorder, uterine perforation, vaginal discharge and vaginal infection to be related to essure.The reporter commented: received treatment for pain: dysmenorrhea (cramping), pelvic/abdominal, back, dyspareunia (painful sexual intercourse), received treatment for bleeding:menorrhagia (heavy menstrual bleeding), gen.Abnormal.Bleed, other, anemia, metrorrhagia (bleeding b/w periods), received treatment for migration, received treatment for perforation:fallopian tubes, uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-sep-2019: pfs received: case become incident.Previously reported event ¿injury¿ replaced by specific events: pain: dysmenorrhea (cramping), pelvic/abdominal, back, dyspareunia (painful sexual intercourse), menorrhagia (heavy menstrual bleeding), gen.Abnormal.Bleed, anemia, metrorrhagia (bleeding b/w periods), migration, perforation: fallopian tubes, uterus, bladder/urinary problems: vaginal.Infection, urinary problems, brain fog and vaginal.Discharge.Product indication and date of essure removal were added, reporter added.Consumer address was updated and birth date added.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('perforation: uterus / migration'), fallopian tube perforation ('perforation: fallopian tubes/migration'), genital haemorrhage ('bleeding: gen.Abnormal.Bleed') and blood loss anaemia ('bleeding: other anemia') in a 34-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "ess and essure confirmation test not conducted" and device ineffective "device ineffective".The patient's medical history included gravida ii and parity 3 ((b)(6) 2009; (b)(6) 2011 and (b)(6) 2016).On (b)(6) 2017, the patient had essure inserted.On (b)(6) 2018, the patient was found to have a pregnancy with contraceptive device ("pregnancy (termination)"), 7 months 25 days after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("pain: dysmennorhea (cramping)"), pelvic pain ("pain: pelvic/ severe pain in pelvic area"), abdominal pain ("pain: abdominal"), back pain ("pain:back"), dyspareunia ("pain: dyspareunia (painful sexual intercourse)"), menorrhagia ("bleeding: menorrhagia (heavy menstrual bleeding)"), blood loss anaemia (seriousness criterion medically significant), metrorrhagia ("bleeding: metorhagia(bleeding b/w periods)"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), vaginal infection ("vaginal.Infection"), vaginal discharge ("vaginal.Discharge"), fatigue ("fatigue"), nervous system disorder ("nuero condit/problem") and feeling abnormal ("brain fog") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (salpingectomy (bilateral) and hysterectomy (partial) and salpingectomy.(bilateral},hysterectomy.(partial)).Essure was removed on (b)(6) 2018.At the time of the report, the uterine perforation, fallopian tube perforation, genital haemorrhage, dysmenorrhoea, pelvic pain, abdominal pain, back pain, dyspareunia, menorrhagia, blood loss anaemia, metrorrhagia, bladder disorder, urinary tract disorder, vaginal infection, vaginal discharge, fatigue, hormone level abnormal, nervous system disorder, feeling abnormal and pregnancy with contraceptive device outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 4, para 3.Last menstrual period and estimated date of delivery were not provided.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal pain, back pain, bladder disorder, blood loss anaemia, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, hormone level abnormal, menorrhagia, metrorrhagia, nervous system disorder, pelvic pain, pregnancy with contraceptive device, urinary tract disorder, uterine perforation, vaginal discharge and vaginal infection to be related to essure.The reporter commented: received treatment for pain: dysmenorrhea (cramping),pelvic/abdominal, back ,dyspareunia (painful sexual intercourse),received treatment for bleeding:menorrhagia (heavy menstrual bleeding),gen.Abnormal.Bleed, other, anemia, metrorrhagia (bleeding b/w periods),received treatment for migration,received treatment for perforation:fallopian tubes, uterus.Discrepancy noted: insertion date (b)(6) 2015 00:00 , removal date: (b)(6) 2018, 2 coils on right and 3 on left.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-nov-2020: pfs and mr received.Reporter's information added.Event: pregnancy (termination), device ineffective, essure confirmation test not conducted were added.Rcc added.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('perforation: uterus / migration'), fallopian tube perforation ('perforation: fallopian tubes/migration'), genital haemorrhage ('bleeding: gen.Abnormal.Bleed') and blood loss anaemia ('bleeding: other anemia') in a 34-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "ess and essure confirmation test not conducted" and device ineffective "device ineffective".The patient's medical history included multigravida and parity 3 ((b)(6) 2009; (b)(6) 2011 and (b)(6) 2016).On (b)(6) 2017, the patient had essure inserted.On (b)(6) 2018, the patient was found to have a pregnancy with contraceptive device ("pregnancy (termination)"), 7 months 25 days after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), blood loss anaemia (seriousness criterion medically significant), dysmenorrhoea ("pain: dysmennorhea (cramping)"), pelvic pain ("pain: pelvic/ severe pain in pelvic area"), abdominal pain ("pain: abdominal"), back pain ("pain:back"), dyspareunia ("pain: dyspareunia (painful sexual intercourse)"), menorrhagia ("bleeding: menorrhagia (heavy menstrual bleeding)"), metrorrhagia ("bleeding: metorhagia(bleeding b/w periods)"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), vaginal infection ("vaginal.Infection"), vaginal discharge ("vaginal.Discharge"), fatigue ("fatigue"), nervous system disorder ("nuero condit/problem") and feeling abnormal ("brain fog") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (salpingectomy (bilateral) and hysterectomy (partial) and salpingectomy.(bilateral},hysterectomy.(partial)).Essure was removed on (b)(6) 2018.At the time of the report, the uterine perforation, fallopian tube perforation, genital haemorrhage, blood loss anaemia, dysmenorrhoea, pelvic pain, abdominal pain, back pain, dyspareunia, menorrhagia, metrorrhagia, bladder disorder, urinary tract disorder, vaginal infection, vaginal discharge, fatigue, hormone level abnormal, nervous system disorder, feeling abnormal and pregnancy with contraceptive device outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 4, para 3.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 elective abortion.The reporter considered abdominal pain, back pain, bladder disorder, blood loss anaemia, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, hormone level abnormal, menorrhagia, metrorrhagia, nervous system disorder, pelvic pain, pregnancy with contraceptive device, urinary tract disorder, uterine perforation, vaginal discharge and vaginal infection to be related to essure.The reporter commented: received treatment for pain: dysmenorrhea (cramping),pelvic/abdominal, back ,dyspareunia (painful sexual intercourse),received treatment for bleeding:menorrhagia (heavy menstrual bleeding),gen.Abnormal.Bleed, other, anemia, metrorrhagia (bleeding b/w periods),received treatment for migration,received treatment for perforation:fallopian tubes, uterus.Discepancy noted: insertion date (b)(6) 2015.Discepancy noted: removal date: (b)(6) 2018.2 coils on right and 3 on left.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-apr-2021: medical record received.Reporters information added.There was no significant change in the medical context of case.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('perforation: uterus / migration'), fallopian tube perforation ('perforation: fallopian tubes/migration'), genital haemorrhage ('bleeding: gen.Abnormal.Bleed') and blood loss anaemia ('bleeding: other anemia') in a 34-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "ess and essure confirmation test not conducted" and device ineffective "device ineffective".The patient's medical history included multigravida and parity 3 ((b)(6) 2009; (b)(6) 2011 and (b)(6) 2016).On (b)(6) 2017, the patient had essure inserted.On (b)(6) 2018, the patient was found to have a pregnancy with contraceptive device ("pregnancy (termination)"), 7 months 25 days after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), blood loss anaemia (seriousness criterion medically significant), dysmenorrhoea ("pain: dysmenorrhea (cramping)"), pelvic pain ("pain: pelvic/ severe pain in pelvic area"), abdominal pain ("pain: abdominal"), back pain ("pain:back"), dyspareunia ("pain: dyspareunia (painful sexual intercourse)"), heavy menstrual bleeding ("bleeding: menorrhagia (heavy menstrual bleeding)"), intermenstrual bleeding ("bleeding: menorrhagia(bleeding b/w periods)"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), vaginal infection ("vaginal.Infection"), vaginal discharge ("vaginal.Discharge"), fatigue ("fatigue"), nervous system disorder ("neuro condition/problem") and feeling abnormal ("brain fog") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (salpingectomy (bilateral) and hysterectomy (partial) and salpingectomy.(bilateral},hysterectomy.(partial)).Essure was removed on (b)(6) 2018.At the time of the report, the uterine perforation, fallopian tube perforation, genital haemorrhage, blood loss anaemia, dysmenorrhoea, pelvic pain, abdominal pain, back pain, dyspareunia, heavy menstrual bleeding, intermenstrual bleeding, bladder disorder, urinary tract disorder, vaginal infection, vaginal discharge, fatigue, hormone level abnormal, nervous system disorder, feeling abnormal and pregnancy with contraceptive device outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 4, para 3.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 elective abortion.The reporter considered abdominal pain, back pain, bladder disorder, blood loss anaemia, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, heavy menstrual bleeding, hormone level abnormal, intermenstrual bleeding, nervous system disorder, pelvic pain, pregnancy with contraceptive device, urinary tract disorder, uterine perforation, vaginal discharge and vaginal infection to be related to essure.The reporter commented: received treatment for pain: dysmenorrhea (cramping),pelvic/abdominal, back ,dyspareunia (painful sexual intercourse),received treatment for bleeding:menorrhagia (heavy menstrual bleeding),gen.Abnormal.Bleed, other, anemia, metrorrhagia (bleeding b/w periods),received treatment for migration,received treatment for perforation:fallopian tubes, uterus.Discrepancy noted: insertion date (b)(6) 2015.Discrepancy noted: removal date: (b)(6) 2018.2 coils on right and 3 on left.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 13-may-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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 9106855
• MDR Text Key: 164248159
• Report Number: 2951250-2019-07964
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 11/23/2020; 04/16/2021; 05/13/2021
• Supplement Dates FDA Received: 12/04/2020; 04/29/2021; 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR