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 12/15/2023

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("i had my fallopian tubes, uterus, and a piece of tissue removed due to adenomyosis.") in a female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2007, the patient had essure inserted.On (b)(6) 2023, 5919 days after essure insertion, she underwent medical device removal (seriousness criterion intervention required).Essure was removed the same day.On unknown date she experienced adenomyosis ("adenomyosis.").The patient was treated with surgery (bilateral salpingectomy & hysteroctomy).At the time of the report, the outcome of adenomyosis was unknown.The reporter considered adenomyosis and medical device removal to be related to essure administration.The reporter commented: after this procedure, various physical symptoms developed.I have since undergone follow up treatments.On (b)(6) 2023, i had my fallopian tubes, uterus, and a piece of tissue removed due to adenomyosis.As a result of the symptoms, i am hindered in my normal daily functioning, and i suffer damages.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 spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("i had my fallopian tubes, uterus, and a piece of tissue removed due to adenomyosis.") 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.On (b)(6) 2007, the patient had essure inserted.On (b)(6) 2023, 5919 days after essure insertion, she underwent medical device removal (seriousness criterion intervention required).Essure was removed the same day.On unknown date she experienced adenomyosis ("adenomyosis.").The patient was treated with surgery (bilateral salpingectomy & hysteroctomy).At the time of the report, the outcome of adenomyosis was unknown.The reporter considered adenomyosis and medical device removal to be related to essure administration.The reporter commented: after this procedure, various physical symptoms developed.I have since undergone follow up treatments.On (b)(6)2023, i had my fallopian tubes, uterus, and a piece of tissue removed due to adenomyosis.As a result of the symptoms, i am hindered in my normal daily functioning, and i suffer damages.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: 27-mar-2024: quality safety evaluation of product technical complaint.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: 18938702
• MDR Text Key: 338067492
• Report Number: 2951250-2024-00203
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2024
• 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 Sex: Female