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

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Foreign Body In Patient (2687)

Event Date 09/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration') and genital haemorrhage ('genital abnormal bleeding') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("physical pain / pelvic pain"), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), genital haemorrhage (seriousness criterion medically significant) and psychological trauma ("psych injury").The patient was treated with treatment not specified.Essure treatment was not changed.At the time of the report, the device dislocation, pelvic pain, abdominal pain, dysmenorrhoea, genital haemorrhage and psychological trauma outcome was unknown.The reporter considered abdominal pain, device dislocation, dysmenorrhoea, genital haemorrhage, pelvic pain and psychological trauma to be related to essure.The reporter commented: received treatment for pain, bleeding, migration - yes.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 04-sep-2019: new pfs received - new events added: abdominal pain, dysmenorrhea (cramping), genital abnormal bleeding, psych injury, migration were added.Product indication was updated.Incident: 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-conformance 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 device dislocation ('migration') and genital haemorrhage ('genital abnormal bleeding') in an adult female patient who had essure (batch no.B27986) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included menometrorrhagia, gravida ii, parity 2 and morbid obesity.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic pain ("physical pain/ pelvic pain"), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), anxiety ("psych injury/mental anguish/ anxiety"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and depression ("depression").The patient was treated with surgery (novasure ablation) and treatment not specified.Essure treatment was not changed.At the time of the report, the device dislocation, genital haemorrhage, pelvic pain, abdominal pain, dysmenorrhoea, anxiety, vaginal haemorrhage, menorrhagia and depression outcome was unknown.The reporter considered abdominal pain, anxiety, depression, device dislocation, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: received treatment for pain, bleeding, migration- yes after deployment 4 coils were visualized.Discrepancy noted: plaintiff did not undergo essure confirmation test.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: vaginal bleeding.Lot number: b27986, manufacture date: 2013-04, expiration date: 2016-04.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 31-oct-2019: quality-safety evaluation of ptc.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 dislocation ('migration') and genital haemorrhage ('genital abnormal bleeding') in an adult female patient who had essure (batch no.B27986) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included menometrorrhagia, gravida ii, parity 2 and morbid obesity.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic pain ("physical pain/ pelvic pain"), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), anxiety ("psych injury/mental anguish/ anxiety"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and depression ("depression").The patient was treated with surgery (novasure ablation) and treatment not specified.Essure treatment was not changed.At the time of the report, the device dislocation, genital haemorrhage, pelvic pain, abdominal pain, dysmenorrhoea, anxiety, vaginal haemorrhage, menorrhagia and depression outcome was unknown.The reporter considered abdominal pain, anxiety, depression, device dislocation, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: received treatment for pain, bleeding, migration- yes after deployment 4 coils were visualized.Discrepancy noted: plaintiff did not undergo essure confirmation test.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: vaginal bleeding most recent follow-up information incorporated above includes: on 14-oct-2019: pfs and mr received.Reporters information updated.Lot no.Were added.Event:psych injury were updated to anxiety.New events:abnormal bleeding (vaginal, menorrhagia), depression were added.Medical history were added.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 dislocation ('migration'), genital haemorrhage ('genital abnormal bleeding') and dysmenorrhoea ('dysmenorrhea (cramping)') in an adult female patient who had essure (batch no.B27986) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included menometrorrhagia, gravida ii, parity 2 and morbid obesity.Concomitant products included medroxyprogesterone acetate (depo-provera) from (b)(6) 2013 to (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced dysmenorrhoea (seriousness criteria medically significant and intervention required), pelvic pain ("physical pain/ pelvic pain"), abdominal pain ("abdominal pain"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("menorrhagia").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), anxiety ("psych injury/mental anguish/ anxiety") and depression ("depression").The patient was treated with nsaids, paracetamol (acetaminophen), surgery (novasure ablation) and treatment not specified.Essure treatment was not changed.At the time of the report, the device dislocation, genital haemorrhage, dysmenorrhoea, pelvic pain, abdominal pain, anxiety, vaginal haemorrhage, menorrhagia and depression outcome was unknown.The reporter considered abdominal pain, anxiety, depression, device dislocation, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: received treatment for pain, bleeding, migration- yes after deployment 4 coils were visualized.Discrepancy noted: earlier the patient underwent essure confirmation test, but in current pfs it was given she did not underwent essure confirmation test.Currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: vaginal bleeding lot number: b27986 manufacture date: 2013-04 expiration date: 2016-04.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-apr-2020: pfs received: treatment of previously reported event dysmenorrhea (cramping) was reported as novasure ablation.Treatment medications acetaminophen, nsaids and concomitant medication depo-provera was added.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.

• 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: 9074518
• MDR Text Key: 159367792
• Report Number: 2951250-2019-06712
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: ESS305
• Device Lot Number: B27986
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO-PROVERA
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR