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

Model Number ESS205

Device Problems Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This spontaneous case was reported by a health professional and describes the occurrence of pelvic pain ('pelvic pain') and complication of device removal ('incomplete exeresis of the left essure implant') in a (b)(6) female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included underweight (bmi 18.443).In 2004, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criterion intervention required), complication of device removal (seriousness criterion intervention required), sleep disorder ("sleep disturbance"), musculoskeletal pain ("diffuse muscle and joint pain") and adenomyosis ("a few foci of adenomyosis in the myometrium.").The patient was treated with surgery (bilateral laparoscopic cornuectomy and secondary surgery sub-total hysterectomy on (b)(6) 2021).Essure (ess205) was removed on (b)(6) 2021.At the time of the report, the pelvic pain, sleep disorder and musculoskeletal pain was resolving and the complication of device removal and adenomyosis outcome was unknown.The reporter considered adenomyosis, complication of device removal, musculoskeletal pain, pelvic pain and sleep disorder to be related to essure (ess205).The reporter commented: essure was removal for medical reasons, medically necessary, diffuse muscle and joint pain, pelvic pain, sleep disturbance, after removal the follow-up was performed 1 month latter, and the symptoms improved from a little to moderate improvement.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.4 kg/sqm.Imaging procedure - on an unknown date: the intraoperative radiological images of the operating parts showed incomplete exeresis of the left essure implant.Pathology test - on an unknown date: presence of a few foci of adenomyosis in the myometrium and hypotrophic uterus.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 health professional and describes the occurrence of pelvic pain ('pelvic pain') in a 59-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: nothing to report.Concurrent conditions included underweight (bmi 18.443).In 2004, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criterion intervention required), adenomyosis ("a few foci of adenomyosis in the myometrium"), musculoskeletal pain ("diffuse muscle and joint pain"), sleep disorder ("sleep disturbance") and complication of device removal ("incomplete exeresis of the left essure implant").The patient was treated with surgery (essure removal, bilateral laparoscopic cornuectomy, secondary sub-total hysterectomy).Essure (ess205) was removed on (b)(6) 2021.At the time of the report, the pelvic pain, adenomyosis, musculoskeletal pain and sleep disorder was resolving and the complication of device removal had resolved.The reporter considered adenomyosis, complication of device removal, musculoskeletal pain, pelvic pain and sleep disorder to be related to essure (ess205).The reporter commented: essure was removed for medical reasons, medically necessary, diffuse muscle and joint pain, pelvic pain, sleep disturbance.After removal the follow-up was performed 1 month later, and the symptoms improved from a little to moderate improvement.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.4 kg/sqm.Imaging procedure - on (b)(6) 2021: the intraoperative radiological images of the operating parts showed incomplete exeresis of the left essure implant.Pathology test - on (b)(6) 2021: presence of a few foci of adenomyosis in the myometrium.Hypotrophic uterus.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 13-jan-2022: quality safety evaluation of product technical complaint (ptc).Essure removal date was updated from (b)(6) 2021 to (b)(6) 2021.Imdrf codes were updated.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 health professional and describes the occurrence of pelvic pain ('pelvic pain') in a 59-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: nothing to report.Concurrent conditions included underweight (bmi 18.443).In 2004, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criterion intervention required), adenomyosis ("a few foci of adenomyosis in the myometrium"), musculoskeletal pain ("diffuse muscle and joint pain"), sleep disorder ("sleep disturbance") and complication of device removal ("incomplete exeresis of the left essure implant").The patient was treated with surgery (essure removal, bilateral laparoscopic cornuectomy, secondary sub-total hysterectomy).Essure (ess205) was removed on (b)(6) 2021.At the time of the report, the pelvic pain, adenomyosis, musculoskeletal pain and sleep disorder was resolving and the complication of device removal had resolved.The reporter considered adenomyosis, complication of device removal, musculoskeletal pain, pelvic pain and sleep disorder to be related to essure (ess205).The reporter commented: essure was removed for medical reasons, medically necessary, diffuse muscle and joint pain, pelvic pain, sleep disturbance.After removal the follow-up was performed 1 month later, and the symptoms improved from a little to moderate improvement.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.4 kg/sqm.Imaging procedure - on (b)(6) 2021: the intraoperative radiological images of the operating parts showed incomplete exeresis of the left essure implant.Pathology test - on (b)(6) 2021: presence of a few foci of adenomyosis in the myometrium.Hypotrophic uterus.Quality-safety evaluation of ptc: the investigation of the sample could not confirm any quality defect.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.Most recent follow-up information incorporated above includes: on 17-feb-2022: 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.

• 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: 13144474
• MDR Text Key: 284840577
• Report Number: 2951250-2022-00009
• 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,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2022
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 49 KG