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

Model Number ESS305

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6), reference number: (b)(4) on 22-jun-2021.This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ('essure removal in (b)(6) 2017, surgery now scheduled for (b)(6) 2021 for total removal of the device and uterus removal') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included multiple sclerosis.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced multiple sclerosis ("significant worsening of ms (multiple sclerosis) symptoms") with headache, pain, urinary tract disorder, dizziness, arthralgia and memory impairment.In february(b)(6) 2017, the patient experienced complication of device removal ("withdrawal surgery in (b)(6) 2017, but implants never removed").On an unknown date, the patient underwent medical device removal (seriousness criterion intervention required), was found to have weight increased ("weight gain (10 kg)") and experienced depression suicidal ("mood disorder: desire to die") and sleep disorder ("major sleep disorders").The patient was treated with fingolimod hydrochloride (gilenya) and natalizumab (tysabri).At the time of the report, the medical device removal and complication of device removal outcome was unknown and the multiple sclerosis, weight increased, depression suicidal and sleep disorder had not resolved.The reporter provided no causality assessment for complication of device removal, depression suicidal, multiple sclerosis, sleep disorder and weight increased with essure.The reporter considered medical device removal to be related to essure.The reporter commented: removal of essure in (b)(6) 2017, further worsening of multiple sclerosis (ms) symptoms, treatment for ms increased.During a kidney ultrasound, chance discovery that the implants had never been removed, even though the patient had a report of the withdrawal operation.Surgery scheduled in (b)(6) 2021 for removal of the uterus and total removal of the device.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6).Ultrasound kidney - on an unknown date: the implants had never been removed.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 22-jun-2021.The most recent information was received on 28-jun-2021.This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ('essure removal in (b)(6) 2017, surgery now scheduled for (b)(6) 2021 for total removal of the device and uterus removal') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included multiple sclerosis.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced multiple sclerosis ("significant worsening of ms (multiple sclerosis) symptoms") with headache, pain, urinary tract disorder, dizziness, arthralgia and memory impairment.In (b)(6) 2017, the patient experienced complication of device removal ("withdrawal surgery in (b)(6) 2017, but implants never removed").On an unknown date, the patient underwent medical device removal (seriousness criterion intervention required), was found to have weight increased ("weight gain (10 kg)") and experienced depression suicidal ("mood disorder: desire to die") and sleep disorder ("major sleep disorders").The patient was treated with fingolimod hydrochloride (gilenya) and natalizumab (tysabri).At the time of the report, the medical device removal and complication of device removal outcome was unknown and the multiple sclerosis, weight increased, depression suicidal and sleep disorder had not resolved.The reporter provided no causality assessment for complication of device removal, depression suicidal, multiple sclerosis, sleep disorder and weight increased with essure.The reporter considered medical device removal to be related to essure.The reporter commented: removal of essure in (b)(6) 2017, further worsening of multiple sclerosis (ms) symptoms, treatment for ms increased.During a kidney ultrasound, chance discovery that the implants had never been removed, even though the patient had a report of the withdrawal operation.Surgery scheduled in (b)(6) 2021 for removal of the uterus and total removal of the device.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 63 kgs.Ultrasound kidney - on an unknown date: the implants had never been removed.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 28-jun-2021: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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: 12059616
• MDR Text Key: 266397533
• Report Number: 2951250-2021-02700
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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: ESS305
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 63