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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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 ("recurrent, debilitating menorrhagia") in a 46 year-old female patient who had essure inserted (lot no.829057).The patient had a medical history of d & c and atrioventricular block (pacemaker for type 2 atrioventricular block) in 2023, pulmonary embolism in 2004 and endometrial ablation, elective abortion and caesarean section (3).As concurrent condition the report mentioned overweight.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).The patient was treated with surgery (total hysterectomy & endometrial ablations via hysteroscopy).At the time of the report, the outcome of the event was unknown.The reporter considered heavy menstrual bleeding to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 27.217 kg/sqm.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

This spontaneous case was reported by a healthcare professional and describes the occurrence of heavy menstrual bleeding ("recurrent, debilitating menorrhagia") in a 46 year-old female patient who had essure inserted (lot no.829057).The patient had a medical history of d & c and atrioventricular block (pacemaker for type 2 atrioventricular block) in 2023, pulmonary embolism in 2004 and endometrial ablation, elective abortion and caesarean section (3).As concurrent condition the report mentioned overweight.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).The patient was treated with surgery (total hysterectomy & endometrial ablations via hysteroscopy).At the time of the report, the outcome of the event was unknown.The reporter considered heavy menstrual bleeding to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 27.217 kg/sqm.Lot number: 829057 manufacture date: 2011-02 expiration date: 2014-02.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: 20-feb-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: 18736841
• MDR Text Key: 335709627
• Report Number: 2951250-2024-00123
• 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
• Report Date: 02/21/2024

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 Expiration Date: 02/01/2014
• Device Model Number: ESS305
• Device Lot Number: 829057
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2024
• Date Device Manufactured: 02/01/2011
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 75 KG