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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('broken proximal right essure device') in a (b)(6) 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 ineffective "device ineffective".The patient's medical history included multigravida, parity 1 ((b)(6) 2006) and recurrent abortion.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced heavy menstrual bleeding ("menorrhagia (heavy menstrual bleeding)/abnormal bleeding, (vaginal, menorrhagia)"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)/dysmenorrhea (cramping)") and vaginal haemorrhage ("abnormal bleeding, (vaginal, menorrhagia)").In (b)(6) 2015, the patient was found to have a pregnancy with contraceptive device ("pregnancy (termination)").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), iron deficiency anaemia ("anemia"), intermenstrual bleeding ("metorhagia (bleeding b/w (interpreted as between) periods"), bladder disorder ("bladder problems"), fatigue ("fatigue"), alopecia ("hair loss") and nausea ("nausea") and was found to have hormone level abnormal ("hormonal changes"), neoplasm ("tumors") and weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the device breakage, pregnancy with contraceptive device, heavy menstrual bleeding, iron deficiency anaemia, back pain, dysmenorrhoea, intermenstrual bleeding, bladder disorder, fatigue, alopecia, hormone level abnormal, nausea, neoplasm, weight increased and vaginal haemorrhage outcome was unknown.Pregnancy related information: retrospective report.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 alopecia, back pain, bladder disorder, device breakage, dysmenorrhoea, fatigue, heavy menstrual bleeding, hormone level abnormal, intermenstrual bleeding, iron deficiency anaemia, nausea, neoplasm, pregnancy with contraceptive device, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: patient received treatment for back pain, dysmenorrhea (cramping).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: one fallopian tube did not close (do not recall which one).Radiographic findings suggestive of a stretched (less likely broken proximal right essure device) with a wisp of contrast within the proximal portion of the right fallopian tube as described above.The left each were device is in satisfactory position.; in (b)(6) 2010: bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021: mr received: case is upgraded to serious incident.Event broken proximal right essure device added.Reporter information and lab data were 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('broken proximal right essure device') in a 33-year-old 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 ineffective "device ineffective".The patient's medical history included multigravida, parity 1 (b)(6) 2006) and recurrent abortion.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced heavy menstrual bleeding ("menorrhagia (heavy menstrual bleeding)/abnormal bleeding, (vaginal, menorrhagia)"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)/dysmenorrhea (cramping)") and vaginal haemorrhage ("abnormal bleeding, (vaginal, menorrhagia)").In (b)(6) 2015, the patient was found to have a pregnancy with contraceptive device ("pregnancy (termination)").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), iron deficiency anaemia ("anemia"), intermenstrual bleeding ("metorhagia (bleeding b/w (interpreted as between) periods"), bladder disorder ("bladder problems"), fatigue ("fatigue"), alopecia ("hair loss") and nausea ("nausea") and was found to have hormone level abnormal ("hormonal changes"), neoplasm ("tumors") and weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the device breakage, pregnancy with contraceptive device, heavy menstrual bleeding, iron deficiency anaemia, back pain, dysmenorrhoea, intermenstrual bleeding, bladder disorder, fatigue, alopecia, hormone level abnormal, nausea, neoplasm, weight increased and vaginal haemorrhage outcome was unknown.Pregnancy related information: retrospective report.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 alopecia, back pain, bladder disorder, device breakage, dysmenorrhoea, fatigue, heavy menstrual bleeding, hormone level abnormal, intermenstrual bleeding, iron deficiency anaemia, nausea, neoplasm, pregnancy with contraceptive device, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: patient received treatment for back pain, dysmenorrhea (cramping).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: one fallopian tube did not close (do not recall which one).Radiographic findings suggestive of a stretched (less likely broken proximal right essure device) with a wisp of contrast within the proximal portion of the right fallopian tube as described above.The left each were device is in satisfactory position.; in (b)(6) 2010: bilateral occlusion.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 30-may-2021: quality safety evaluation of product technical complaint 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: 11892432
• MDR Text Key: 258078931
• Report Number: 2951250-2021-02442
• 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
• Report Date: 05/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Date Manufacturer Received: 05/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR