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

Model Number ESS305

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Presyncope (4410)

Event Date 06/01/2023

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4) on 26-mar-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of presyncope ("vasovagal episode") in an adult female patient who had essure inserted (lot no.50707329) for female sterilization.Additional non-serious events are detailed below.Product or product use issues identified: device material corroded ("heavy metal intoxication following degradation and corrosion of these gynaecological implants").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2013, the patient had essure inserted.In 2018 she experienced visual impairment ("vision problem/ decompensation of vision") and auditory disorder ("hearing disorder/ decompensation of hearing").In mid 2022 she experienced anxiety ("anxiety").In (b)(6) 2023 she experienced presyncope (seriousness criterion medically important) and fatigue ("chronic fatigue").On (b)(6) 2023 she experienced hypertension ("hypertension"), cognitive disorder ("cognitive"), disturbance in attention ("difficulty concentrating on a simple task"), sleep disorder ("sleep disorder"), arthralgia ("muscle and joint pains"), language disorder ("language disorders"), muscle spasms ("muscle spasms"), neck pain ("neck pain"), musculoskeletal stiffness ("muscle stiffness"), limb discomfort ("feeling of extremely heavy legs"), cardiovascular disorder ("poor blood circulation"), hypertonic bladder ("hyperactive bladder +3-4 nocturnal voids"), hot flush ("hot flushes"), dry skin ("dry skin,"), dyspnoea ("breathlessness"), exercise tolerance decreased (" intolerance to exertion"), temperature intolerance ("sensitivity to the cold") and myalgia ("muscle and joint pains").On unknown date she experienced conversion disorder ("functional neurological disorders (fnd)."), gait disturbance ("difficulty walking for long periods"), micturition urgency ("urinary urgency"), metal poisoning ("heavy metal intoxication following degradation and corrosion of these gynaecological implants"), vision blurred ("difficulty focusing"), burnout syndrome ("burnout syndrome") and memory impairment ("memory disorders").At the time of the report, the outcomes for presyncope, conversion disorder, hypertension, cognitive disorder, disturbance in attention, sleep disorder, arthralgia, language disorder, muscle spasms, musculoskeletal stiffness, limb discomfort, cardiovascular disorder, gait disturbance, hypertonic bladder, micturition urgency, hot flush, dry skin, dyspnoea, exercise tolerance decreased, temperature intolerance, metal poisoning, visual impairment, auditory disorder, vision blurred, burnout syndrome, memory impairment and anxiety were unknown.No causality assessment was received for essure with regard to fatigue, presyncope, conversion disorder, hypertension, cognitive disorder, disturbance in attention, sleep disorder, arthralgia, language disorder, muscle spasms, neck pain, musculoskeletal stiffness, limb discomfort, cardiovascular disorder, gait disturbance, hypertonic bladder, micturition urgency, hot flush, dry skin, dyspnoea, exercise tolerance decreased, temperature intolerance, metal poisoning, visual impairment, auditory disorder, vision blurred, burnout syndrome, memory impairment, myalgia or anxiety.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 84 kg.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

The below report was received by health authority ansm (reference number: (b)(4) on 26-mar-2024.The most recent information was received on 04-apr-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of presyncope ("vasovagal episode") in an adult female patient who had essure inserted (lot no.50707329) for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: device material corroded ("heavy metal intoxication following degradation and corrosion of these gynaecological implants").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2013, the patient had essure inserted.In 2018 she experienced visual impairment ("vision problem / decompensation of vision") and auditory disorder ("hearing disorder / decompensation of hearing").In 2022 she experienced anxiety ("anxiety").In (b)(6) 2023 she experienced presyncope (seriousness criterion medically important) and fatigue ("chronic fatigue").On (b)(6) 2023 she experienced hypertension ("hypertension"), cognitive disorder ("cognitive"), disturbance in attention ("difficulty concentrating on a simple task"), sleep disorder ("sleep disorder"), arthralgia ("muscle and joint pains"), language disorder ("language disorders"), muscle spasms ("muscle spasms"), neck pain ("neck pain"), musculoskeletal stiffness ("muscle stiffness"), limb discomfort ("feeling of extremely heavy legs"), cardiovascular disorder ("poor blood circulation"), hypertonic bladder ("hyperactive bladder +3-4 nocturnal voids"), hot flush ("hot flushes"), dry skin ("dry skin,"), dyspnoea ("breathlessness"), exercise tolerance decreased (" intolerance to exertion"), temperature intolerance ("sensitivity to the cold") and myalgia ("muscle and joint pains").On unknown date she experienced conversion disorder ("functional neurological disorders (fnd)."), gait disturbance ("difficulty walking for long periods"), micturition urgency ("urinary urgency"), metal poisoning ("heavy metal intoxication following degradation and corrosion of these gynaecological implants"), vision blurred ("difficulty focusing"), burnout syndrome ("burnout syndrome") and memory impairment ("memory disorders").At the time of the report, the outcomes for presyncope, conversion disorder, hypertension, cognitive disorder, disturbance in attention, sleep disorder, arthralgia, language disorder, muscle spasms, musculoskeletal stiffness, limb discomfort, cardiovascular disorder, gait disturbance, hypertonic bladder, micturition urgency, hot flush, dry skin, dyspnoea, exercise tolerance decreased, temperature intolerance, metal poisoning, visual impairment, auditory disorder, vision blurred, burnout syndrome, memory impairment and anxiety were unknown.No causality assessment was received for essure with regard to fatigue, presyncope, conversion disorder, hypertension, cognitive disorder, disturbance in attention, sleep disorder, arthralgia, language disorder, muscle spasms, neck pain, musculoskeletal stiffness, limb discomfort, cardiovascular disorder, gait disturbance, hypertonic bladder, micturition urgency, hot flush, dry skin, dyspnoea, exercise tolerance decreased, temperature intolerance, metal poisoning, visual impairment, auditory disorder, vision blurred, burnout syndrome, memory impairment, myalgia or anxiety.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 84 kg.Lot number: 50707329 manufacture date: 2012-12 expiration date: 2015-12.Quality-safety evaluation of ptc: for essure: 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: 04-apr-2024: 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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 19010113
• MDR Text Key: 338981745
• Report Number: 2951250-2024-00223
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2012
• Device Model Number: ESS305
• Device Lot Number: 50707329
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2024
• Date Device Manufactured: 12/01/2015
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 84 KG