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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2024

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4)) on 18-mar-2024.This spontaneous case was originally reported by a healthcare professional and describes the occurrence of medical device removal ("medical device removal") in a female patient who had essure inserted (lot no.A30482) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.In 2013, the patient had essure inserted.On unknown date she experienced myalgia ("for the last several years, poorly labelled, diffuse muscle pain").On (b)(6) 2024,, she underwent medical device removal (seriousness criterion intervention required).Essure was removed the same day.The patient was treated with surgery (to remove essure ).At the time of the report, the outcome of myalgia was unknown.No causality assessment was received for essure with regard to medical device removal or myalgia.The reporter commented: period of occurrence: for the last several years.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

The below report was received by health authority ansm (reference number: (b)(4)) on 18-mar-2024.The most recent information was received on 26-mar-2024.This spontaneous case was originally reported by a healthcare professional and describes the occurrence of medical device removal ("medical device removal") in a female patient who had essure inserted for permanent contraceptive tubal implant.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.In 2013, the patient had essure inserted.On (b)(6) 2024, she underwent medical device removal (seriousness criterion intervention required).Essure was removed the same day.On unknown date she experienced myalgia ("for the last several years, poorly labelled, diffuse muscle pain").The patient was treated with surgery (to remove essure).At the time of the report, the outcome of myalgia was unknown.No causality assessment was received for essure with regard to medical device removal or myalgia.The reporter commented: period of occurrence: for the last several years.Batch number a30482 is invalid.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 26-mar-2024: quality safety evaluation of product technical complaint.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.

Manufacturer Narrative

The below report was received by health authority ansm (reference number: (b)(4) on 18-mar-2024.The most recent information was received on 17-apr-2024.This spontaneous case was originally reported by a healthcare professional and describes the occurrence of medical device removal ("medical device removal") in a 40 year-old female patient who had essure inserted for permanent contraceptive tubal implant.Additional non-serious events are detailed below.The patient had a medical history of overweight, tonsillectomy, appendectomy, umbilical hernia, caesarean section, smoker, migraine, raynauds and fibromyalgia.On (b)(6) 2013, the patient had essure inserted.In 2013 she experienced myalgia ("for the last several years, poorly labelled, diffuse muscle pain").On (b)(6) 2024 she underwent medical device removal (seriousness criterion intervention required).Essure was removed the same day.The patient was treated with surgery (laparoscopy/bilateral salpingectomy]).At the time of the report, the outcome of myalgia was unknown.No causality assessment was received for essure with regard to medical device removal or myalgia.The reporter commented: period of occurrence: for the last several years.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 28.374 kg/sqm.Batch number a30482 is not valid.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 17-apr-2024: quality safety evaluation of ptc.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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 18966821
• MDR Text Key: 338432336
• Report Number: 2951250-2024-00207
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: A30482
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2024
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 82 KG