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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Flatus (1865); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Blurred Vision (2137); Loss of Vision (2139); Dizziness (2194); Dysphasia (2195); Sleep Dysfunction (2517); Heavier Menses (2666); Constipation (3274)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority afssaps (reference number: (b)(4)) on 22-dec-2017.This spontaneous case was reported by a consumer and describes the occurrence of back pain ("low back pain") and blindness ("blurred vision (vision loss, near or distant)") in a female patient who had essure (batch no.C68124) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), blindness (seriousness criterion medically significant), fatigue ("tiredness"), musculoskeletal pain ("muscle pain/ joint pain"), headache ("headache"), neck pain ("nape pain"), dizziness ("dizziness"), flatulence ("belly pain (gas)"), irritable bowel syndrome ("irritable bowel syndrome (diarrhea, constipation)") with diarrhoea and constipation, breast pain ("breast pain"), menorrhagia ("haemorrhagic menstruations with strong pain in low abdomen"), dysmenorrhoea ("haemorrhagic menstruations with strong pain in low abdomen"), alopecia ("hair loss"), loss of libido ("absence of libido"), insomnia ("insomnia"), amnesia ("memory loss"), speech disorder ("speech problems") and vision blurred ("blurred vision (vision loss, near or distant)").Essure treatment was not changed.At the time of the report, the back pain, blindness, fatigue, musculoskeletal pain, headache, neck pain, dizziness, flatulence, irritable bowel syndrome, breast pain, menorrhagia, dysmenorrhoea, alopecia, loss of libido, insomnia, amnesia, speech disorder and vision blurred outcome was unknown.The reporter provided no causality assessment for alopecia, amnesia, back pain, blindness, breast pain, dizziness, dysmenorrhoea, fatigue, flatulence, headache, insomnia, irritable bowel syndrome, loss of libido, menorrhagia, musculoskeletal pain, neck pain, speech disorder and vision blurred with essure.The reporter commented: removal of essure was scheduled on (b)(6) 2018.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 28-dec-2017 for the following meddra preferred term: back pain.The analysis in the global safety database revealed 3.927 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.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 case was initially received via regulatory authority (b)(6) (reference number: (b)(4)) on 22-dec-2017.This spontaneous case was reported by a consumer and describes the occurrence of back pain ("low back pain") and blindness ("blurred vision (vision loss, near or distant)") in a female patient who had essure (batch no.C68124) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), blindness (seriousness criterion medically significant), fatigue ("tiredness"), musculoskeletal pain ("muscle pain/ joint pain"), headache ("headache"), neck pain ("nape pain"), dizziness ("dizziness"), flatulence ("belly pain (gas)"), irritable bowel syndrome ("irritable bowel syndrome (diarrhea, constipation)") with diarrhoea and constipation, breast pain ("breast pain"), menorrhagia ("haemorrhagic menstruations with strong pain in low abdomen"), dysmenorrhoea ("haemorrhagic menstruations with strong pain in low abdomen"), alopecia ("hair loss"), loss of libido ("absence of libido"), insomnia ("insomnia"), amnesia ("memory loss"), speech disorder ("speech problems") and vision blurred ("blurred vision (vision loss, near or distant)").Essure treatment was not changed.At the time of the report, the back pain, blindness, fatigue, musculoskeletal pain, headache, neck pain, dizziness, flatulence, irritable bowel syndrome, breast pain, menorrhagia, dysmenorrhoea, alopecia, loss of libido, insomnia, amnesia, speech disorder and vision blurred outcome was unknown.The reporter provided no causality assessment for alopecia, amnesia, back pain, blindness, breast pain, dizziness, dysmenorrhoea, fatigue, flatulence, headache, insomnia, irritable bowel syndrome, loss of libido, menorrhagia, musculoskeletal pain, neck pain, speech disorder and vision blurred with essure.The reporter commented: removal of essure was scheduled on (b)(6) 2018.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 05-jan-2018 for the following meddra preferred term: back pain.The analysis in the global safety database revealed 466 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: 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 case was initially received via regulatory authority (b)(6) (reference number: (b)(4)) on 22-dec-2017.The most recent information was received on 17-jan-2018.This spontaneous case was reported by a consumer and describes the occurrence of back pain ("low back pain") and blindness ("blurred vision (vision loss, near or distant)") in a female patient who had essure (batch no.C68124) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6)-2015, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), blindness (seriousness criterion medically significant), fatigue ("tiredness"), musculoskeletal pain ("muscle pain/ joint pain"), headache ("headache"), neck pain ("nape pain"), dizziness ("dizziness"), flatulence ("belly pain (gas)"), irritable bowel syndrome ("irritable bowel syndrome (diarrhea, constipation)") with diarrhoea and constipation, breast pain ("breast pain"), menorrhagia ("haemorrhagic menstruations with strong pain in low abdomen"), dysmenorrhoea ("haemorrhagic menstruations with strong pain in low abdomen"), alopecia ("hair loss"), loss of libido ("absence of libido"), insomnia ("insomnia"), amnesia ("memory loss"), speech disorder ("speech problems") and vision blurred ("blurred vision (vision loss, near or distant)").Essure treatment was not changed.At the time of the report, the back pain, blindness, fatigue, musculoskeletal pain, headache, neck pain, dizziness, flatulence, irritable bowel syndrome, breast pain, menorrhagia, dysmenorrhoea, alopecia, loss of libido, insomnia, amnesia, speech disorder and vision blurred outcome was unknown.The reporter provided no causality assessment for alopecia, amnesia, back pain, blindness, breast pain, dizziness, dysmenorrhoea, fatigue, flatulence, headache, insomnia, irritable bowel syndrome, loss of libido, menorrhagia, musculoskeletal pain, neck pain, speech disorder and vision blurred with essure.The reporter commented: removal of essure was scheduled on (b)(6)-2018.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 19-jan-2018 for the following meddra preferred term: back pain.The analysis in the global safety database revealed 477 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.Most recent follow-up information incorporated above includes: on 17-jan-2018: quality safety evaluation of ptc incident 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.

• 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: 7150525
• MDR Text Key: 95922815
• Report Number: 2951250-2017-11160
• 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
• Report Date: 01/19/2018

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: 06/30/2017
• Device Model Number: ESS305
• Device Lot Number: C68124
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 12/22/2017; 01/17/2018
• Supplement Dates FDA Received: 01/05/2018; 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention