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

Model Number ESS305

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Anemia (1706); Cyst(s) (1800); Fatigue (1849); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Perforation (2001); Urinary Tract Infection (2120); Uterine Perforation (2121); Vomiting (2144); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("essure device protruding through the myometrium in the right corneal area behind the right fallopian tube"), pelvic pain ("pelvic pain") and device breakage ("the part of the essure was removed but physician was unsure if more of the devie was in myometrium") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), abdominal pain ("abdominal pain"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), anaemia ("anaemia"), fatigue ("fatigue"), menstruation irregular ("irregular cycle / irregular vaginal bleeding"), vaginal haemorrhage ("vaginal bleeding up to three weeks out of the month"), metrorrhagia ("metrorrhagia"), ovarian cyst ("ovarian cyst") with suprapubic pain, urinary tract infection ("urinary tract infection"), genital disorder female ("unspecified symptom female genital organs"), polymenorrhoea ("two menstrual cycles per month"), menstrual disorder ("menstrual disorder"), nausea ("nausea"), vomiting ("vomiting") and complication of device removal ("physician removed part of essure device").The patient was treated with antibiotics, oral contraceptive nos, surgery (the part of the essure was removed) and surgery (diagnostic laparoscopy).Essure was removed.At the time of the report, the uterine perforation, pelvic pain, device breakage, abdominal pain, menorrhagia, dysmenorrhoea, dyspareunia, anaemia, fatigue, menstruation irregular, vaginal haemorrhage, metrorrhagia, ovarian cyst, urinary tract infection, genital disorder female, polymenorrhoea, menstrual disorder, nausea, vomiting and complication of device removal outcome was unknown.The reporter considered abdominal pain, anaemia, complication of device removal, device breakage, dysmenorrhoea, dyspareunia, fatigue, genital disorder female, menorrhagia, menstrual disorder, menstruation irregular, metrorrhagia, nausea, ovarian cyst, pelvic pain, polymenorrhoea, urinary tract infection, uterine perforation, vaginal haemorrhage and vomiting to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: no spillage demonstrated.Ultrasound scan - on (b)(6) 2013: functional cysts in ovaries and essure present.X-ray - in (b)(6) 2009: no acute disease.During diagnostic laparoscopy , physician discovered that essure was protruding for approximately 1,5 cm almost through the myometrium.Physician removed part of the essure that he could see but she was unsure if more of the device was buried in the myometrium.On (b)(6) 2013: transvaginal ultrasound revealed a focal area within the right ovary of slight heterogeneity but well circumscribed.Incident.No lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("essure device protruding through the myometrium in the right corneal area behind the right fallopian tube"), pelvic pain ("pelvic pain") and device breakage ("the part of the essure was removed but physician was unsure if more of the devie was in myometrium") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), abdominal pain ("abdominal pain"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), anaemia ("anaemia"), fatigue ("fatigue"), menstruation irregular ("irregular cycle / irregular vaginal bleeding"), vaginal haemorrhage ("vaginal bleeding up to three weeks out of the month"), metrorrhagia ("metrorrhagia"), ovarian cyst ("ovarian cyst") with suprapubic pain, urinary tract infection ("urinary tract infection"), genital disorder female ("unspecified symptom female genital organs"), polymenorrhoea ("two menstrual cycles per month"), menstrual disorder ("menstrual disorder"), nausea ("nausea"), vomiting ("vomiting") and complication of device removal ("physician removed part of essure device").The patient was treated with antibiotics, oral contraceptive nos, surgery (the part of the essure was removed) and surgery (diagnostic laparoscopy).Essure was removed.At the time of the report, the uterine perforation, pelvic pain, device breakage, abdominal pain, menorrhagia, dysmenorrhoea, dyspareunia, anaemia, fatigue, menstruation irregular, vaginal haemorrhage, metrorrhagia, ovarian cyst, urinary tract infection, genital disorder female, polymenorrhoea, menstrual disorder, nausea, vomiting and complication of device removal outcome was unknown.The reporter considered abdominal pain, anaemia, complication of device removal, device breakage, dysmenorrhoea, dyspareunia, fatigue, genital disorder female, menorrhagia, menstrual disorder, menstruation irregular, metrorrhagia, nausea, ovarian cyst, pelvic pain, polymenorrhoea, urinary tract infection, uterine perforation, vaginal haemorrhage and vomiting to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: no spillage demonstrated ultrasound scan - on (b)(6) 2013: functional cysts in ovaries and essure present x-ray - in (b)(6) 2009: no acute disease during diagnostic laparoscopy , physician discovered that essure was protruding for approximately 1,5 cm almost through the myometrium.Physician removed part of the essure that he could see but she was unsure if more of the device was buried in the myometrium.(b)(6) 2013: transvaginal ultrasound revealed a focal area within the right ovary of slight heterogeneity but well circumscribed.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 21-jun-2018: quality safety evaluation of ptc.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration'), uterine perforation ('essure device protruding through the myometrium in the right corneal area behind the right fallopian tube'), pelvic pain ('pelvic pain/worsening pain') and device breakage ('the part of the essure was removed but physician was unsure if more of the devie was in myometrium') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), anaemia ("anaemia"), fatigue ("fatigue"), menstruation irregular ("irregular cycle / irregular vaginal bleeding"), vaginal haemorrhage ("vaginal bleeding up to three weeks out of the month"), metrorrhagia ("metrorrhagia"), ovarian cyst ("ovarian cyst") with suprapubic pain, urinary tract infection ("urinary tract infection"), female reproductive tract disorder ("unspecified symptom female genital organs"), polymenorrhoea ("two menstrual cycles per month"), menstrual disorder ("menstrual disorder"), nausea ("nausea"), vomiting ("vomiting"), complication of device removal ("physician removed part of essure device") and genital haemorrhage ("abnormal bleeding").The patient was treated with antibiotics, oral contraceptive nos and surgery (diagnostic laparoscopy and the part of the essure was removed).Essure was removed.At the time of the report, the device dislocation, uterine perforation, pelvic pain, device breakage, abdominal pain, menorrhagia, dysmenorrhoea, dyspareunia, anaemia, fatigue, menstruation irregular, vaginal haemorrhage, metrorrhagia, ovarian cyst, urinary tract infection, female reproductive tract disorder, polymenorrhoea, menstrual disorder, nausea, vomiting, complication of device removal and genital haemorrhage outcome was unknown.The reporter considered abdominal pain, anaemia, complication of device removal, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, female reproductive tract disorder, genital haemorrhage, menorrhagia, menstrual disorder, menstruation irregular, metrorrhagia, nausea, ovarian cyst, pelvic pain, polymenorrhoea, urinary tract infection, uterine perforation, vaginal haemorrhage and vomiting to be related to essure.The reporter commented: during diagnostic laparoscopy , physician discovered that essure was protruding for approximately 1,5 cm almost through the myometrium.Physician removed part of the essure that he could see but she was unsure if more of the device was buried in the myometrium.(b)(6) 2013: transvaginal ultrasound revealed a focal area within the right ovary of slight heterogeneity but well circumscribed diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: results: no spillage demonstrated.Ultrasound scan - on (b)(6) 2013: results: functional cysts in ovaries and essure present.X-ray - in (b)(6) 2009: results: no acute disease.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration'), uterine perforation ('essure device protruding through the myometrium in the right corneal area behind the right fallopian tube'), pelvic pain ('pelvic pain/worsening pain') and device breakage ('the part of the essure was removed but physician was unsure if more of the devie was in myometrium') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), anaemia ("anaemia"), fatigue ("fatigue"), menstruation irregular ("irregular cycle / irregular vaginal bleeding"), vaginal haemorrhage ("vaginal bleeding up to three weeks out of the month"), metrorrhagia ("metrorrhagia"), ovarian cyst ("ovarian cyst") with suprapubic pain, urinary tract infection ("urinary tract infection"), female reproductive tract disorder ("unspecified symptom female genital organs"), polymenorrhoea ("two menstrual cycles per month"), menstrual disorder ("menstrual disorder"), nausea ("nausea"), vomiting ("vomiting"), complication of device removal ("physician removed part of essure device") and genital haemorrhage ("abnormal bleeding").The patient was treated with antibiotics, oral contraceptive nos and surgery (diagnostic laparoscopy and the part of the essure was removed).Essure was removed.At the time of the report, the device dislocation, uterine perforation, pelvic pain, device breakage, abdominal pain, menorrhagia, dysmenorrhoea, dyspareunia, anaemia, fatigue, menstruation irregular, vaginal haemorrhage, metrorrhagia, ovarian cyst, urinary tract infection, female reproductive tract disorder, polymenorrhoea, menstrual disorder, nausea, vomiting, complication of device removal and genital haemorrhage outcome was unknown.The reporter considered abdominal pain, anaemia, complication of device removal, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, female reproductive tract disorder, genital haemorrhage, menorrhagia, menstrual disorder, menstruation irregular, metrorrhagia, nausea, ovarian cyst, pelvic pain, polymenorrhoea, urinary tract infection, uterine perforation, vaginal haemorrhage and vomiting to be related to essure.No further causality assessment were provided for the product.The reporter commented: during diagnostic laparoscopy , physician discovered that essure was protruding for approximately 1,5 cm almost through the myometrium.Physician removed part of the essure that he could see but she was unsure if more of the device was buried in the myometrium.(b)(6) 2013: transvaginal ultrasound revealed a focal area within the right ovary of slight heterogeneity but well circumscribed diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: results: no spillage demonstrated.Ultrasound scan - on (b)(6) 2013: results: functional cysts in ovaries and essure present.X-ray - in january 2009: results: no acute disease.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs received new reporter information was added.New event migration, genital bleeding was 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.

Event Description

Hold for cr 10.5.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration'), uterine perforation ('essure device protruding through the myometrium in the right corneal area behind the right fallopian tube'), pelvic pain ('pelvic pain/worsening pain') and device breakage ('the part of the essure was removed but physician was unsure if more of the devie was in myometrium') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included grand multiparity, ovarian cystectomy and ovarian cyst.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), heavy menstrual bleeding ("menorrhagia"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), anaemia ("anaemia"), fatigue ("fatigue"), menstruation irregular ("irregular cycle / irregular vaginal bleeding"), vaginal haemorrhage ("vaginal bleeding up to three weeks out of the month"), intermenstrual bleeding ("metrorrhagia"), ovarian cyst ("ovarian cyst") with suprapubic pain, urinary tract infection ("urinary tract infection"), female reproductive tract disorder ("unspecified symptom female genital organs"), polymenorrhoea ("two menstrual cycles per month"), menstrual disorder ("menstrual disorder"), nausea ("nausea"), vomiting ("vomiting"), complication of device removal ("physician removed part of essure device") and genital haemorrhage ("abnormal bleeding").The patient was treated with antibiotics, oral contraceptive nos and surgery (diagnostic laparoscopy and the part of the essure was removed).Essure was removed on (b)(6) 2019.At the time of the report, the device dislocation, uterine perforation, pelvic pain, device breakage, abdominal pain, heavy menstrual bleeding, dysmenorrhoea, dyspareunia, anaemia, fatigue, menstruation irregular, vaginal haemorrhage, intermenstrual bleeding, ovarian cyst, urinary tract infection, female reproductive tract disorder, polymenorrhoea, menstrual disorder, nausea, vomiting, complication of device removal and genital haemorrhage outcome was unknown.The reporter considered abdominal pain, anaemia, complication of device removal, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, female reproductive tract disorder, genital haemorrhage, heavy menstrual bleeding, intermenstrual bleeding, menstrual disorder, menstruation irregular, nausea, ovarian cyst, pelvic pain, polymenorrhoea, urinary tract infection, uterine perforation, vaginal haemorrhage and vomiting to be related to essure.The reporter commented: right: three coils visualized within the endometrial cavity during diagnostic laparoscopy , physician discovered that essure was protruding for approximately 1,5 cm almost through the myometrium.Physician removed part of the essure that he could see but she was unsure if more of the device was buried in the myometrium.(b)(6) 2013: transvaginal ultrasound revealed a focal area within the right ovary of slight heterogeneity but well circumscribed diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - (b)(6) 2009: results: no spillage demonstrated.Ultrasound scan: (b)(6) 2013: results: functional cysts in ovaries and essure present.X-ray: (b)(6) 2009: results: no acute disease.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes:(b)(6) 2021: mr received: reporter, medical history, essure removal date and rcc added.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• 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: 7507503
• MDR Text Key: 108092848
• Report Number: 2951250-2018-02145
• Device Sequence Number: 1
• Product Code: HHS
• 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,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention