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); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Anemia (1706); Emotional Changes (1831); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of dysmenorrhoea ('dysmenorrhea (cramping)'), genital haemorrhage ('general abnormal bleeding'), menorrhagia ('menorrhagia (heavy menstrual bleeding)') and blood loss anaemia ('anemia') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced dysmenorrhoea (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), menorrhagia (seriousness criterion medically significant), blood loss anaemia (seriousness criterion medically significant), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), psychological trauma ("psych injury"), fatigue ("fatigue"), headache ("headaches") and nausea ("nausea") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (partial hysterectomy with unilateral salpingectomy on (b)(6) 2011.).At the time of the report, the dysmenorrhoea, genital haemorrhage, menorrhagia, blood loss anaemia, pelvic pain and abdominal pain had resolved and the psychological trauma, fatigue, hormone level abnormal and headache outcome was unknown.The reporter considered abdominal pain, blood loss anaemia, dysmenorrhoea, fatigue, genital haemorrhage, headache, hormone level abnormal, menorrhagia, nausea, pelvic pain and psychological trauma to be related to essure.The reporter commented: discrepancy noted in essure insertion date patient received treatment for dysmenorrhea (cramping), pelvic/abdominal pain, menorrhagia (heavy menstrual bleeding), anemia, gen.Abnormal bleed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-sep-2019: pfs received events " dysmenorrhea (cramping), pelvic/abdominal pain, menorrhagia (heavy menstrual bleeding), anemia, gen.Abnormal.Bleeding, psych injury, fatigue, hormonal changes, headaches, nausea, she did not undergo essure confirmation test" were added.Outcome of events "pain, bleeding" were updated as recovered.No lot number 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 dysmenorrhoea ('dysmenorrhea (cramping)') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included headache, migraine headache, d & c and ganglion cyst.Concurrent conditions included vaginal yeast infection, cough, abnormal uterine bleeding, grand multiparity, menometrorrhagia, uterine fibroid, abnormal uterine bleeding and menses irregular.Concomitant products included medroxyprogesterone acetate (depo provera).On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced dysmenorrhoea (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), iron deficiency anaemia ("anemia"), heavy menstrual bleeding ("menorrhagia (heavy menstrual bleeding)"), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), psychological trauma ("psych injury"), fatigue ("fatigue"), headache ("headaches") and nausea ("nausea") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (partial hysterecomy with unilateral salpingectomy on (b)(6) 2011.).At the time of the report, the dysmenorrhoea, genital haemorrhage, iron deficiency anaemia, heavy menstrual bleeding, pelvic pain and abdominal pain had resolved and the psychological trauma, fatigue, hormone level abnormal and headache outcome was unknown.The reporter considered abdominal pain, dysmenorrhoea, fatigue, genital haemorrhage, headache, heavy menstrual bleeding, hormone level abnormal, iron deficiency anaemia, nausea, pelvic pain and psychological trauma to be related to essure.The reporter commented: discrepancy noted in essure insertion date patient received treatment for dysmenorrhea (cramping),pelvic/abdominal pain, menorrhagia (heavy menstrual bleeding), anemia, general abnormal bleed discrepancy noted:date(s) of insertion: (b)(6) 2011, (b)(6) 2010.The coil was grossly visible and noted approximately 8 to 10 coils were seen along with the noted essure wire that was meant to be further up within the ostia.Trial at essure placement with left side placed, right side not able to be placed with ensuing laparoscopic fulguration bilaterally in (b)(6) 2011.Anterior repair and monarc sling were also performed at that time.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 (b)(6) 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of dysmenorrhoea ('dysmenorrhea (cramping)') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included headache, migraine headache, d & c and ganglion cyst.Concurrent conditions included vaginal yeast infection, cough, uterine bleeding, grand multiparity, menometrorrhagia, uterine fibroid, uterine bleeding and menses irregular.Concomitant products included medroxyprogesterone acetate (depo provera).On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced dysmenorrhoea (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), iron deficiency anaemia ("anemia"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), psychological trauma ("psych injury"), fatigue ("fatigue"), headache ("headaches") and nausea ("nausea") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (partial hysterecomy with unilateral salpingectomy on (b)(6) 2011.).At the time of the report, the dysmenorrhoea, genital haemorrhage, iron deficiency anaemia, menorrhagia, pelvic pain and abdominal pain had resolved and the psychological trauma, fatigue, hormone level abnormal and headache outcome was unknown.The reporter considered abdominal pain, dysmenorrhoea, fatigue, genital haemorrhage, headache, hormone level abnormal, iron deficiency anaemia, menorrhagia, nausea, pelvic pain and psychological trauma to be related to essure.The reporter commented: discrepancy noted in essure insertion date patient received treatment for dysmenorrhea (cramping),pelvic/abdominal pain, menorrhagia (heavy menstrual bleeding), anemia, gen.Abnormal bleed discrepancy noted:date(s) of insertion: (b)(6) 2011, (b)(6) 2010.The coil was grossly visible and noted approximately 8 to 10 coils were seen along with the noted essure wire that was meant to be further up within the ostia.Trial at essure placement with left side placed, right side not able to be placed with ensuing laparoscopic fulguration bilaterally in (b)(6) 2011.Anterior repair and monarc sling were also performed at that time.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-apr-2021: mr received.Reporter information, medical history and rcc were added.Real fu was received and 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.

• 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: 9121846
• MDR Text Key: 163130517
• Report Number: 2951250-2019-08516
• 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
• Report Date: 05/14/2021

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: 09/11/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 04/13/2021; 05/04/2021
• Supplement Dates FDA Received: 04/26/2021; 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO PROVERA; DEPO PROVERA
• Patient Outcome(s): Other; Required Intervention