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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Anemia (1706); Emotional Changes (1831); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Anxiety (2328); Depression (2361); Heavier Menses (2666)

Event Date 07/01/2010

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('physical pain') and genital haemorrhage ('gen.Abnorm.Bleed') in a female patient who had essure (batch no.708871) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included miscarriage, menometrorrhagia, migraine, urinary incontinence and gastrooesophageal reflux disease.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), anxiety ("psych injury:psychological or psychiatric problems condition: anxiety/ mental anguish"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("psych injury:psychological or psychiatric problems condition: depression"), migraine ("migraines / headaches") and dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), abdominal pain ("abdominal pain"), anaemia ("bleeding: anemia") and complication of device removal ("i still have right coil ins ide that is causing me issues").The patient was treated with surgery (hysterectomy with unilateral salpingectomy - left side).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain and anaemia had resolved and the anxiety, vaginal haemorrhage, menorrhagia, female sexual dysfunction, depression, migraine, dysmenorrhoea and complication of device removal outcome was unknown.The reporter considered abdominal pain, anaemia, anxiety, complication of device removal, depression, dysmenorrhoea, female sexual dysfunction, genital haemorrhage, menorrhagia, migraine, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: plaintiff receive treatment for bleeding.Discrepancy noted for date of insertion (b)(6) 2010 and (b)(6) 2010.Insertion details: the essure procedure was performed per protocol.Trailing coils: left ¿ 02, right - 02.Discrepancy noted for essure confirmation test that the plaintiff did not undergo this 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 described in patients medical record confirming: vaginal haemorrhage, anemia.Most recent follow-up information incorporated above includes: on 5-sep-2019: ppf received.Added event abdominal pain, anemia, gen, abnorm.Bleed., psych injury.Updated outcome of events pain & bleeding from unknown to recovered/resolved.Date of removal was added.On 22-oct-2019: fu 2& fu3 process together.Pfs & mr received.Lot number was added.Added event abnormal bleeding (vaginal, menorrhagia), apareunia (inability to have sexual intercourse),migraine/headaches, blood or heart disorder/ condition type: anemia, dysmenorrhea (cramping), pt updated for event psych injury to psychological or psychiatric problems condition: anxiety, depression and mental anguish.Medical history, concomitant conditions were added.Reporter's information was added.Patient's demographics was added.Incident: 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 pelvic pain ('physical pain') and genital haemorrhage ('gen.Abnorm.Bleed') in a female patient who had essure (batch no.708871) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included miscarriage, menometrorrhagia, migraine, urinary incontinence and gastrooesophageal reflux disease.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), anxiety ("psych injury:psychological or psychiatric problems condition: anxiety/ mental anguish"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("psych injury:psychological or psychiatric problems condition: depression"), migraine ("migraines / headaches") and dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), abdominal pain ("abdominal pain"), anaemia ("bleeding: anemia") and complication of device removal ("i still have right coil ins ide that is causing me issues").The patient was treated with surgery (hysterectomy with unilateral salpingectomy - left side).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain and anaemia had resolved and the anxiety, vaginal haemorrhage, menorrhagia, female sexual dysfunction, depression, migraine, dysmenorrhoea and complication of device removal outcome was unknown.The reporter considered abdominal pain, anaemia, anxiety, complication of device removal, depression, dysmenorrhoea, female sexual dysfunction, genital haemorrhage, menorrhagia, migraine, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: plaintiff receive treatment for bleeding.Discrepancy noted for date of insertion (b)(6) 2010 and (b)(6) 2010.Insertion details: the essure procedure was performed per protocol.Trailing coils: left ¿ 02, right - 02.Discrepancy noted for essure confirmation test that the plaintiff did not undergo this 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 described in patients medical record confirming: vaginal haemorrhage, anemia.Lot number: 708871 manufacture date: 2010-01 expiration date: 2013-01.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 product technical complaint.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 pelvic pain ('physical pain') in a female patient who had essure (batch no.708871) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included miscarriage, menometrorrhagia, migraine, urinary incontinence and gastrooesophageal reflux disease.On(b)(6)2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), anxiety ("psych injury:psychological or psychiatric problems condition: anxiety/ mental anguish"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("psych injury:psychological or psychiatric problems condition: depression"), migraine ("migraines / headaches") and dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced genital haemorrhage ("gen.Abnorm.Bleed"), abdominal pain ("abdominal pain"), anaemia ("bleeding: anemia"), complication of device removal ("i still have right coil ins ide that is causing me issues"), metrorrhagia ("metrorrhagia") and post procedural complication ("post procedural complication").The patient was treated with surgery (hysterectomy with unilateral salpingectomy - left side).Essure was removed on (b)(6)2016.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, anaemia and metrorrhagia had resolved and the anxiety, vaginal haemorrhage, menorrhagia, female sexual dysfunction, depression, migraine, dysmenorrhoea, complication of device removal and post procedural complication outcome was unknown.The reporter considered abdominal pain, anaemia, anxiety, complication of device removal, depression, dysmenorrhoea, female sexual dysfunction, genital haemorrhage, menorrhagia, metrorrhagia, migraine, pelvic pain, post procedural complication and vaginal haemorrhage to be related to essure.The reporter commented: plaintiff receive treatment for bleeding.Discrepancy noted for date of insertion (b)(6)2010 and (b)(6) 2010.Insertion details: the essure procedure was performed per protocol.Trailing coils: left ¿ 02, right - 02 discrepancy noted for essure confirmation test that the plaintiff did not undergo this test.Received treatment for - bleeding 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 described in patients medical record confirming: vaginal haemorrhage, anemia.Lot number: 708871 manufacture date: 2010-01 expiration date: 2013-01 quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on(b)(6) 2020: pfs received- new events metrorrhagia post procedural complication were added.Repoters were added.On (b)(6) 2020: no new clinical information.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, 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: 9252468
• MDR Text Key: 177689713
• Report Number: 2951250-2019-10863
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2020

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 Expiration Date: 01/01/2013
• Device Model Number: ESS305
• Device Lot Number: 708871
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 05/05/2020
• Supplement Dates FDA Received: 11/07/2019; 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR