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

Model Number ESS205

Device Problems Patient-Device Incompatibility (2682); Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Dyspnea (1816); Emotional Changes (1831); Pain (1994); Vomiting (2144); Burning Sensation (2146)

Event Date 02/21/2017

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm (b)(4).This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("belly ache") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), diarrhoea ("diarrhea"), vomiting ("vomiting"), burning sensation ("burnt face"), emotional distress ("loss of moral") and dyspnoea ("breathlessness").The patient will be treated with surgery (operation to remove essure planned).Essure treatment was not changed.At the time of the report, the abdominal pain, diarrhoea, vomiting, burning sensation, emotional distress and dyspnoea outcome was unknown.The reporter provided no causality assessment for abdominal pain, burning sensation, diarrhoea, dyspnoea, emotional distress and vomiting with essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on 21-aug-2017 for the following meddra preferred term: abdominal pain.The analysis in the global safety database revealed 1154 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Further company follow-up with the regulatory authority is not possible.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 case was initially received via regulatory authority (ansm, reference number: (b)(4)) on (b)(6)2017.The most recent information was received on (b)(6)2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") in a 41-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "on the left side, i think the implant does a little too accentuated curvature" on (b)(6)2017.Medical conditions: digestive explorations are negative.On (b)(6)2007, the patient had essure (ess205) inserted.On (b)(6)2007, the patient experienced fallopian tube spasm ("slight spasm during the insertion of the right insert") and complication of device insertion ("slight spasm during the insertion of the right insert").On (b)(6)2017, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menometrorrhagia ("menometrorrhagia"), dysmenorrhoea ("menstrual pain") and general symptom ("non-gynaecological symptoms").On an unknown date, the patient experienced abdominal pain ("belly ache"), diarrhoea ("diarrhea"), vomiting ("vomiting"), burning sensation ("burnt face"), emotional distress ("loss of moral"), dyspnoea ("breathlessness") and adenomyosis ("adenomyosis").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy).Essure (ess205) was removed on (b)(6)2017.At the time of the report, the pelvic pain, abdominal pain, menometrorrhagia, dysmenorrhoea, diarrhoea, vomiting, burning sensation, emotional distress, dyspnoea, general symptom, adenomyosis, fallopian tube spasm and complication of device insertion outcome was unknown.The reporter provided no causality assessment for abdominal pain, burning sensation, diarrhoea, dyspnoea, emotional distress and vomiting with essure (ess205).The reporter considered adenomyosis, complication of device insertion, dysmenorrhoea, fallopian tube spasm, general symptom, menometrorrhagia and pelvic pain to be related to essure (ess205).The reporter commented: essure insertion was performed on (b)(6)2007, 2-3 trailing coils for left insert and 5 trailing coils for right insert.On(b)(6)2017, total hysterectomy and bilateral salpingectomy was performed.No complications reported.Note: the date referring to the accentuated curvature of the left implant ((b)(6)2017) is later than the date of essure removal ((b)(6)2017).Diagnostic results (normal ranges are provided in parenthesis if available): investigation - on (b)(6)2017: on the left side, the implant does a little too accentuated curvature.Physical examination - on an unknown date: did not reveal any particular anomalies.Ultrasound pelvis - on an unknown date: confirms the existence of adenomyosis.Further company follow-up with the regulatory authority or lawyer is not possible.Most recent follow-up information incorporated above includes: on (b)(6)2019: essure insertion details provided; slight spasm during insertion of the right insert and adenomyosis were added as event; lab data added.No lot number or device sample was received in this case.We will conduct a review of our complaints 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 case was initially received via regulatory authority (ansm, reference number: r1710556, r1903478) on (b)(6)2017.The most recent information was received on (b)(6)2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") in a 50-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "on the left side, i think the implant does a little too accentuated curvature" on (b)(6)2017.On (b)(6)2007, the patient had essure (ess205) inserted.On (b)(6)2017, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menometrorrhagia ("menometrorrhagia"), dysmenorrhoea ("menstrual pain") and general symptom ("non-gynaecological symptoms"), 9 years 7 months after insertion of essure (ess205).On an unknown date, the patient experienced abdominal pain ("belly ache"), diarrhoea ("diarrhea"), vomiting ("vomiting"), burning sensation ("burnt face"), emotional distress ("loss of moral") and dyspnoea ("breathlessness").The patient was treated with surgery (essure removal).Essure (ess205) was removed on (b)(6)2017.At the time of the report, the pelvic pain, abdominal pain, menometrorrhagia, dysmenorrhoea, diarrhoea, vomiting, burning sensation, emotional distress, dyspnoea and general symptom outcome was unknown.The reporter provided no causality assessment for abdominal pain, burning sensation, diarrhoea, dyspnoea, emotional distress and vomiting with essure (ess205).The reporter considered dysmenorrhoea, general symptom, menometrorrhagia and pelvic pain to be related to essure (ess205).The reporter commented: note: the date referring to the accentuated curvature of the left implant ((b)(6)2017) is later than the date of essure removal ((b)(6)2017).Diagnostic results (normal ranges are provided in parenthesis if available): investigation - on (b)(6)2017: on the left side, the implant does a little too accentuated curvature.Further company follow-up with the regulatory authority or lawyer is not possible.Most recent follow-up information incorporated above includes: on (b)(6)2019: during a cluster reconciliation, and following confirmation from the local health authorities, case (b)(4)(legacy device report num mfr (b)(4)) was identified as a duplicate of this case and was deleted.All case information from (b)(4) was transferred to this case.New reporter lawyer added; patient¿s intials and date of birth provided; essure model changed to 205 because it was was inserted on (b)(6)2007 and removed on (b)(6)2017; pelvic pain, menometrorrhagia, menstrual pain, non-gynecological symptoms, and on the left side, i think the implant does a little too accentuated curvature were added as event.No lot number or device sample was received in this case.We will conduct a review of our complaints 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 case was initially received via regulatory authority (ansm, reference number: (b)(4)on (b)(6) 2017.The most recent information was received on (b)(6) 2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") in a 41-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "on the left side, i think the implant does a little too accentuated curvature" on (b)(6) 2017.Medical conditions: digestive explorations are negative.On (b)(6) 2007, the patient had essure (ess205) inserted.On (b)(6) 2007, the patient experienced fallopian tube spasm ("slight spasm during the insertion of the right insert") and complication of device insertion ("slight spasm during the insertion of the right insert").On (b)(6) 2017, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menometrorrhagia ("menometrorrhagia"), dysmenorrhoea ("menstrual pain") and general symptom ("non-gynaecological symptoms").On an unknown date, the patient experienced abdominal pain ("belly ache"), diarrhoea ("diarrhea"), vomiting ("vomiting"), burning sensation ("burnt face"), emotional distress ("loss of moral"), dyspnoea ("breathlessness") and adenomyosis ("adenomyosis").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, abdominal pain, menometrorrhagia, dysmenorrhoea, diarrhoea, vomiting, burning sensation, emotional distress, dyspnoea, general symptom, adenomyosis, fallopian tube spasm and complication of device insertion outcome was unknown.The reporter provided no causality assessment for abdominal pain, burning sensation, diarrhoea, dyspnoea, emotional distress and vomiting with essure (ess205).The reporter considered adenomyosis, complication of device insertion, dysmenorrhoea, fallopian tube spasm, general symptom, menometrorrhagia and pelvic pain to be related to essure (ess205).The reporter commented: essure insertion was performed on (b)(6) 2007, 2-3 trailing coils for left insert and 5 trailing coils for right insert.On (b)(6) 2017, total hysterectomy and bilateral salpingectomy was performed.No complications reported.Note: the date referring to the accentuated curvature of the left implant (b)(6) 2017) is later than the date of essure removal (b)(6) 2017).Diagnostic results (normal ranges are provided in parenthesis if available): investigation - on (b)(6) 2017: on the left side, the implant does a little too accentuated curvature.Physical examination - on an unknown date: did not reveal any particular anomalies.Ultrasound pelvis - on an unknown date: confirms the existence of adenomyosis.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or lawyer is not possible.Most recent follow-up information incorporated above includes: on 15-mar-2019: quality safety evaluation of ptc.No lot number or device sample was received in this case.We conducted a review of our complaints 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.

• 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: 6849229
• MDR Text Key: 85154165
• Report Number: 2951250-2017-03396
• 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,foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2019

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: ESS205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 02/07/2019; 03/08/2019; 03/15/2019
• Supplement Dates FDA Received: 02/14/2019; 03/14/2019; 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41 YR