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); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/01/2015

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pain on the right side - (b)(6) 2015, (b)(6) 2017, (b)(6) 2018, (b)(6) 2018, (b)(6) 2020 and (b)(6) 2022)") in an adult female patient who had essure inserted (lot no.C26941).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2015 she experienced pelvic pain (seriousness criterion intervention required).In (b)(6) 2017 she experienced amnesia ("memory loss").In (b)(6) 2017 she experienced bladder disorder ("bladdder urgency").In (b)(6) 2018 she experienced back pain ("back pain ((b)(6) 2018, (b)(6) 2020 and (b)(6) 2022)") and abnormal uterine bleeding ("haemorrhagic periods (b)(6) 2018 and (b)(6) 2020)").In june 2020 she experienced fatigue ("fatigue") and intervertebral disc protrusion ("discovery of a herniated disc").Essure was removed on (b)(6) 2022.The patient was treated with surgery (essure removal and hernia operation, narrow lumbar canal (b)(6) 2020),).At the time of the report, the outcomes for these events were unknown.The reporter considered abnormal uterine bleeding, amnesia, back pain, fatigue, intervertebral disc protrusion and pelvic pain to be related to essure administration.No causality assessment was received for essure with regard to bladder disorder.The reporter commented: (b)(6) 2020: mri of spine - unknown result (b)(6) 2022: pelvic mri - unknown result.Diagnostic results (normal ranges are provided in parenthesis if available): [magnetic resonance imaging abdominal] in (b)(6) 2018: presence of adenomyosis [ultrasound pelvis] in (b)(6) 2017: normal examination; in (b)(6) 2017: normal examination; in september 2018: normal examination.[x-ray of pelvis and hip] in (b)(6) 2015: normal examination.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: (b)(6) 2022: patient's date of birth added, adverse events were specified: pelvic pain, back pain, memory loss, bladder disorder, haemorrhagic periods, fatigue, herniated disc, the essure lot number and the start and stop date were provided (essure removed) and lab datas were added.We received a lot number in this case.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 case was initially received via regulatory authority (ansm, reference number: (b)(4) on 23-sep-2022.The most recent information was received on 03-nov-2022.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ('pain on the right side - (b)(6) 2015, (b)(6) 2017, (b)(6) 2018, (b)(6) 2018, (b)(6) 2020 and (b)(6) 2022) / pelvic pain ') in a 42-year-old female patient who had essure (batch no.C26941) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2015, the patient experienced pelvic pain (seriousness criterion intervention required).In (b)(6) 2017, the patient experienced amnesia ("memory loss / loss of memory and concentration ").In (b)(6) 2017, the patient experienced bladder disorder ("bladdder urgency").In (b)(6) 2018, the patient experienced back pain ("back pain ((b)(6) 2018, (b)(6) 2020 and (b)(6) 2022)") and abnormal uterine bleeding ("haemorrhagic periods ((b)(6) 2018 and (b)(6) 2020) / haemorrhagic periods ").In (b)(6) 2020, the patient experienced fatigue ("fatigue") and intervertebral disc protrusion ("discovery of a herniated disc").On an unknown date, the patient experienced musculoskeletal pain ("musculoskeletal pain") and disturbance in attention ("loss of concentration").The patient was treated with surgery (essure removal and hernia operation, narrow lumbar canal ((b)(6) 2020),).Essure was removed on (b)(6) 2022.At the time of the report, the pelvic pain, bladder disorder, amnesia, back pain, abnormal uterine bleeding, fatigue and intervertebral disc protrusion outcome was unknown.The reporter provided no causality assessment for bladder disorder with essure.The reporter considered abnormal uterine bleeding, amnesia, back pain, disturbance in attention, fatigue, intervertebral disc protrusion, musculoskeletal pain and pelvic pain to be related to essure.The reporter commented: (b)(6) 2020: mri of spine - unknown result (b)(6) 2022: pelvic mri - unknown result diagnostic results (normal ranges are provided in parenthesis if available): magnetic resonance imaging abdominal - in (b)(6) 2018: presence of adenomyosis.Ultrasound pelvis - in (b)(6) 2017: normal examination; in (b)(6) 2017: normal examination; in (b)(6) 2018: normal examination.X-ray of pelvis and hip - in (b)(6) 2015: normal examination.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 3-nov-2022: upon receiving a internal review, it was confirmed that (b)(4) and (b)(4) are duplicates of each other.All the information from deleted duplicate case (b)(4) transferred to the retention case (b)(4).E2b company number added , events - "musculoskeletal pain,concentration loss" added ,reporter information added we received a lot number in this case.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 23-sep-2022.The most recent information was received on 09-nov-2022.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("pain on the right side - (b)(6) 2015, (b)(6) 2017, (b)(6) 2018, (b)(6) 2018, (b)(6) 2020 and (b)(6) 2022) / pelvic pain") in a 42 year-old female patient who had essure inserted (lot no.C26941).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2015 she experienced pelvic pain (seriousness criterion intervention required).In (b)(6) 2017 she experienced amnesia ("memory loss / loss of memory and concentration ").In (b)(6) 2017 she experienced bladder disorder ("bladdder urgency").In (b)(6) 2018 she experienced back pain ("back pain ((b)(6) 2018, (b)(6) 2020 and (b)(6) 2022)") and abnormal uterine bleeding ("haemorrhagic periods ((b)(6) 2018 and (b)(6) 2020) / haemorrhagic periods ").In (b)(6) 2020 she experienced fatigue ("fatigue") and intervertebral disc protrusion ("discovery of a herniated disc").Essure was removed on (b)(6) 2022.An unknown time later she experienced musculoskeletal pain ("musculoskeletal pain") and disturbance in attention ("loss of concentration").The patient was treated with surgery (essure removal and hernia operation, narrow lumbar canal ((b)(6) 2020)).At the time of the report, the outcomes for pelvic pain, bladder disorder, amnesia, back pain, abnormal uterine bleeding, fatigue and intervertebral disc protrusion were unknown.The reporter considered abnormal uterine bleeding, amnesia, back pain, disturbance in attention, fatigue, intervertebral disc protrusion, musculoskeletal pain and pelvic pain to be related to essure administration.No causality assessment was received for essure with regard to bladder disorder.The reporter commented: (b)(6) 2020: mri of spine - unknown result (b)(6) 2022: pelvic mri - unknown result.Diagnostic results (normal ranges are provided in parenthesis if available): [magnetic resonance imaging abdominal] in (b)(6) 2018: presence of adenomyosis [ultrasound pelvis] in (b)(6) 2017: normal examination; in (b)(6) 2017: normal examination; in (b)(6) 2018: normal examination [x-ray of pelvis and hip] in (b)(6) 2015: normal examination batch no c26941 production date 2014-02-21 expiration date 2017-02-28.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: 09-nov-2022: quality safety evaluation of ptc.We received a lot number in this case.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: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 15595014
• MDR Text Key: 301642158
• Report Number: 2951250-2022-01186
• 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,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: ESS305
• Device Lot Number: C26941
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2022
• Date Device Manufactured: 02/21/2014
• 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: 42 YR
• Patient Sex: Female