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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Menorrhagia (4508)

Event Type  Injury  

Event Description

This spontaneous case was reported by a healthcare professional and describes the occurrence of heavy menstrual bleeding ("menorrhagia") in a 50 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of appendectomy and inguinal hernia (right inguinal hernia treated with placement of support plate, right saphenous vein stripping).On (b)(6) 2011, the patient had essure inserted.Essure was removed on (b)(6) 2023.On unknown date she experienced heavy menstrual bleeding (seriousness criterion intervention required), dysmenorrhoea ("dysmenorrhoea"), dyspareunia ("dyspareunia"), intermenstrual bleeding ("metrorrhagia") and asthenia ("asthenia").The patient was treated with surgery (ovarian hysterectomy via laparoscopy).At the time of the report, the outcomes for these events were unknown.The reporter considered asthenia, dysmenorrhoea, dyspareunia, heavy menstrual bleeding and intermenstrual bleeding to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 31.935 kg/sqm.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 healthcare professional and describes the occurrence of heavy menstrual bleeding ("menorrhagia") in a 50 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of appendectomy and inguinal hernia (right inguinal hernia treated with placement of support plate, right saphenous vein stripping).On (b)(6) 2011, the patient had essure inserted.Essure was removed on (b)(6) 2023.On unknown date she experienced heavy menstrual bleeding (seriousness criterion intervention required), dysmenorrhoea ("dysmenorrhoea"), dyspareunia ("dyspareunia"), intermenstrual bleeding ("metrorrhagia") and asthenia ("asthenia").The patient was treated with surgery (ovarian hysterectomy via laparoscopy).At the time of the report, the outcomes for these events were unknown.The reporter considered asthenia, dysmenorrhoea, dyspareunia, heavy menstrual bleeding and intermenstrual bleeding to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 31.935 kg/sqm.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: (b)(6) 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.

Manufacturer Narrative

This spontaneous case was reported by a healthcare professional and describes the occurrence of heavy menstrual bleeding ("menorrhagia") in a 50 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of appendectomy and inguinal hernia (right inguinal hernia treated with placement of support plate, right saphenous vein stripping).On (b)(6) 2011, the patient had essure inserted.Essure was removed on (b)(6) 2023.On unknown date she experienced heavy menstrual bleeding (seriousness criterion intervention required), dysmenorrhoea ("dysmenorrhoea"), dyspareunia ("dyspareunia"), intermenstrual bleeding ("metrorrhagia") and asthenia ("asthenia").The patient was treated with surgery (ovarian hysterectomy via laparoscopy).At the time of the report, the outcomes for these events were unknown.The reporter considered asthenia, dysmenorrhoea, dyspareunia, heavy menstrual bleeding and intermenstrual bleeding to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 31.935 kg/sqm.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: 22-feb-2024: upon receiving a new follow-up information, it was confirmed that cases (b)(4) & (b)(4) are duplicates of each other.Therefore case (b)(4) needs to be marked for deletion.All information from deletion case including source documents, events reporters, medical history, product and patient details has been transferred to retention case.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: 18736980
• MDR Text Key: 335719393
• Report Number: 2951250-2024-00125
• Device Sequence Number: 1
• Product Code: HHS
• 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,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• 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: 02/22/2024
• 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: 88 KG