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

Model Number ESS305

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Headache (1880); Nausea (1970); Blurred Vision (2137); Dizziness (2194); Depression (2361); Sweating (2444); Constipation (3274)

Event Date 01/01/2012

Event Type  Injury  

Event Description

On (b)(6) 2017: this female subject was enrolled in a company-sponsored interventional study titled "use of transvaginal ultrasound to confirm essure® micro-insert placement in women: demonstration of effectiveness" (protocol: (b)(4)).The subject (patient id: (b)(6)) had fallopian tube occlusion insert (batch no.816062) inserted.The report describes a case of abdominal pain ("abdominal pain"), spinal pain ("spine pain"), insomnia ("insomnia "), headache ("headaches"), abdominal distension ("bloating"), vision blurred ("blurred vision"), sinus congestion ("sinus congestion"), fatigue ("fatigue"), dizziness ("dizziness"), breath odour ("halitosis"), constipation ("constipation"), night sweats ("night sweats"), pyrexia ("fever"), chills ("chills"), nausea ("nausea"), depression ("depression"), and mood swings ("extreme mood swings").On (b)(6) 2011, the subject started fallopian tube occlusion insert.On (b)(6) 2012, the subject experienced abdominal pain (intervention required), spinal pain, insomnia, headache, abdominal distension, vision blurred, sinus congestion, fatigue, dizziness, breath odour, constipation, night sweats, pyrexia, chills, nausea, depression and mood swings.The subject was treated with surgery (coils removed during a planned bilateral salpingectomy).Fallopian tube occlusion insert was withdrawn on (b)(6) 2013.At the time of the report, the events outcome was not recovered.Patient withdrew from study (final outcome unknown).Fallopian tubes removed at subject request.Follow-up from (b)(6) 2017: sae pages received.Patient and event causality information updated.Company causality comment this medically confirmed, study case report refers to a female subject who was involved in an interventional company sponsored study (study number: (b)(4)).She presented abdominal pain and a bilateral salpingectomy was performed to essure's removal.The reported event is regarded as non-serious and anticipated according to the investigator's brochure for essure.Chronic abdominal pain is highly prevalent in women, and may have gynaecological and nongynaecological causes.Abdominal pain may occur after essure insertion in this particular case, investigator consider the event related to essure.Bayer concurs with investigator's assessment and regards the event pelvic pain related to essure, given its nature and in the absence of alternative explanation.This case was regarded as incident since device removal was required.A product technical analysis and further information is awaited.

Manufacturer Narrative

This female subject was enrolled in a company-sponsored interventional study titled "use of transvaginal ultrasound to confirm essure® micro-insert placement in women: demonstration of effectiveness" (protocol: 16974).The subject (patient id: 09010) had fallopian tube occlusion insert (batch no.816062) inserted.The report describes a case of abdominal pain ("abdominal pain"), spinal pain ("spine pain"), insomnia ("insomnia "), headache ("headaches"), abdominal distension ("bloating"), vision blurred ("blurred vision"), sinus congestion ("sinus congestion"), fatigue ("fatigue"), dizziness ("dizziness"), breath odour ("halitosis"), constipation ("constipation"), night sweats ("night sweats"), pyrexia ("fever"), chills ("chills"), nausea ("nausea"), depression ("depression"), and mood swings ("extreme mood swings").On (b)(6) 2011, the subject started fallopian tube occlusion insert.On (b)(6) 2012, the subject experienced abdominal pain (intervention required), spinal pain, insomnia, headache, abdominal distension, vision blurred, sinus congestion, fatigue, dizziness, breath odour, constipation, night sweats, pyrexia, chills, nausea, depression and mood swings.The subject was treated with surgery (coils removed during a planned bilateral salpingectomy).Fallopian tube occlusion insert was withdrawn on (b)(6) 2013.At the time of the report, the events outcome was not recovered.Patient withdrew from study (final outcome unknown).Fallopian tubes removed at subject request.Follow-up from (b)(6) 2017: sae pages received.Patient and event causality information updated.Follow-up information received on 05-jul-2017: device evaluation received.No other information was received.Company causality comment: at the time of reporting, 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 adult female subject was enrolled in a company-sponsored interventional study titled: "use of transvaginal ultrasound to confirm essure micro-insert placement in women: demonstration of effectiveness" (protocol: 16974).The subject (patient id: (b)(6)) had fallopian tube occlusion insert (lot no.816062) inserted for sterilisation.The case describes the occurrence of abdominal pain ("abdominal pain").Additional non-serious events are detailed below.There was no information on the subject's medical history or concurrent conditions.On (b)(6) 2011, the subject had fallopian tube occlusion insert inserted.In (b)(6) 2012 she experienced abdominal pain (seriousness criteria medically important and intervention required), spinal pain ("spine pain"), insomnia ("insomnia"), headache ("headaches"), abdominal distension ("bloating"), vision blurred ("blurred vision"), sinus congestion ("sinus congestion"), fatigue ("fatigue"), dizziness ("dizziness"), breath odour ("halatosis"), constipation ("constipation"), night sweats ("night sweats"), pyrexia ("fever"), chills ("chills"), nausea ("nausea"), depression ("depression") and mood swings ("extreme mood swings").Fallopian tube occlusion insert was removed on (b)(6) 2013.The subject was treated with surgery (essure coils removed during a bilateral laparoscoy salpingectomy on (b)(6) 2013).At the time of the report, none of the events had resolved.The investigator considered abdominal pain to be related to fallopian tube occlusion insert administration but saw no causal relationship between spinal pain, insomnia, headache, abdominal distension, vision blurred, sinus congestion, fatigue, dizziness, breath odour, constipation, night sweats, pyrexia, chills, nausea, depression or mood swings and fallopian tube occlusion insert.The reporter commented: fallopian tubes removed at subject request.Patient withdrew from study (final outcome unknown).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 20.245 kg/sqm.The most recent follow-up information incorporated above includes data received on: 05-jul-2017: quality-safety evaluation of ptc.10-may-2023: after company internal review, the company assessment of the event headache was regarded as unrelated in agréement with investigator and for the event bloating the reconciliation comment 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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This adult female subject was enrolled in a company-sponsored interventional study titled: "use of transvaginal ultrasound to confirm essure micro-insert placement in women: demonstration of effectiveness" (protocol: (b)(4)).The subject (patient id: (b)(6)) had fallopian tube occlusion insert (lot no.816062) inserted for sterilisation.The case describes the occurrence of abdominal pain ("abdominal pain").Additional non-serious events are detailed below.There was no information on the subject's medical history or concurrent conditions.On (b)(6) 2011, the subject had fallopian tube occlusion insert inserted.In (b)(6) 2012 she experienced abdominal pain (seriousness criteria medically important and intervention required), spinal pain ("spine pain"), insomnia ("insomnia"), headache ("headaches"), abdominal distension ("bloating"), vision blurred ("blurred vision"), sinus congestion ("sinus congestion"), fatigue ("fatigue"), dizziness ("dizziness"), breath odour ("halatosis"), constipation ("constipation"), night sweats ("night sweats"), pyrexia ("fever"), chills ("chills"), nausea ("nausea"), depression ("depression") and mood swings ("extreme mood swings").Fallopian tube occlusion insert was removed on (b)(6) 2013 via bilateral laparoscoy salpingectomy.At the time of the report, none of the events had resolved.The investigator considered abdominal pain to be related to fallopian tube occlusion insert administration but saw no causal relationship between spinal pain, insomnia, headache, abdominal distension, vision blurred, sinus congestion, fatigue, dizziness, breath odour, constipation, night sweats, pyrexia, chills, nausea, depression or mood swings and fallopian tube occlusion insert.The reporter commented: fallopian tubes removed at subject request.Patient withdrew from study (final outcome unknown).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 20.245 kg/sqm.Lot number: 816062 manufacture date: 2011-01 expiration date: 2014-01-31.Quality-safety evaluation of ptc: for fallopian tube occlusion insert: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 02-jun-2023: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was 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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj, NJ 07981-0915
• MDR Report Key: 6530175
• MDR Text Key: 73960658
• Report Number: 2951250-2017-01740
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/05/2023

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: 01/31/2014
• Device Model Number: ESS305
• Device Lot Number: 816062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: 07/05/2017; 07/05/2017; 06/02/2023
• Supplement Dates FDA Received: 07/19/2017; 05/10/2023; 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 64 KG