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

Model Number ESS305

Device Problems Break (1069); Biocompatibility (2886); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ('foreign body material has been removed') in a female patient who had essure inserted for female sterilisation.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.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 ('foreign body material has been partly removed') and device breakage ('foreign body material has been partly removed') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("the foreign body material has been partly removed").The patient was treated with surgery (removal of essure).Essure was removed.At the time of the report, the medical device removal, device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage and medical device removal to be related to essure.Amendment: the report was amended for the following reason: as reported term updated to "the foreign body material has been partly removed" and the events device breakage and device removal incomplete were added.No new follow-up information was received from the reporter.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 lawyer and describes the occurrence of medical device removal ('the foreign body material has been partly removed') and device breakage ('the foreign body material has been partly removed') in a female patient who had essure (batch no.50647767) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("the foreign body material has been partly removed").The patient was treated with surgery (removal of essure).Essure was removed.At the time of the report, the medical device removal, device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage and medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-may-2020: 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('foreign body material has been partly removed') and device breakage ('foreign body material has been partly removed') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("the foreign body material has been partly removed").The patient was treated with surgery (removal of essure).Essure was removed.At the time of the report, the medical device removal, device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage and medical device removal to be related to essure.Most recent follow-up information incorporated above includes: on 6-may-2020: report now received from lawyer.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 lawyer and describes the occurrence of medical device removal ('foreign body material has been partly removed') and device breakage ('foreign body material has been partly removed') in a female patient who had essure (batch no.50647767) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("the foreign body material has been partly removed").The patient was treated with surgery (removal of essure).Essure was removed.At the time of the report, the medical device removal, device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage and medical device removal to be related to essure.Amendment: the report was amended for the following reason: lot number was added.No new follow-up information was received from the reporter.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 spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('the foreign body material has been partly removed') and device breakage ('the foreign body material has been partly removed') in a female patient who had essure (batch no.50647767) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("the foreign body material has been partly removed").The patient was treated with surgery (removal of essure).Essure was removed.At the time of the report, the medical device removal, device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage and medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-mar-2021: no new information.Sig due to imdrf-fda synchronization.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

This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('the foreign body material has been partly removed') and device breakage ('the foreign body material has been partly removed') in a female patient who had essure (batch no.50647767) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("the foreign body material has been partly removed").The patient was treated with surgery (removal of essure).Essure was removed.At the time of the report, the medical device removal, device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage and medical device removal to be related to essure.The reporter commented: various physical complaints developed after this treatment.Since then she had had follow-up treatments and the foreign body material was partly removed.She was hindered in her normal daily functioning and suffered damage.Lot number: 50647767, manufacturing date: 2012/02, expiration date: 2015/02.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 15-mar-2021: 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain ('severe (chronic) pain in the abdomen') and device breakage ('the foreign body material has been partly removed') in a female patient who had essure (batch no.50647767) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "the foreign body material has been partly removed".On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), back pain ("back pain"), arthralgia ("hips pain"), headache ("head pain"), fatigue ("extreme and chronic fatigue"), amnesia ("memory loss"), disturbance in attention ("concentration problems"), menstrual disorder ("menstrual cycle changed"), abnormal uterine bleeding ("abnormally heavy bleeding"), hypersensitivity ("allergic reactions") and mood swings ("mood swings") and was found to have hormone level abnormal ("hormonal problems").The patient was treated with surgery (removal of essure / partially removed).Essure was removed.At the time of the report, the abdominal pain, device breakage, back pain, arthralgia, headache, fatigue, amnesia, disturbance in attention, menstrual disorder, abnormal uterine bleeding, hormone level abnormal, hypersensitivity and mood swings outcome was unknown.The reporter provided no causality assessment for abnormal uterine bleeding, amnesia, arthralgia, back pain, disturbance in attention, fatigue, headache, hormone level abnormal, hypersensitivity, menstrual disorder and mood swings with essure.The reporter considered abdominal pain and device breakage to be related to essure.The reporter commented: various physical complaints developed after this treatment.Since then she had follow-up treatments and the foreign body material was partly removed.She was hindered in her normal daily functioning and suffered damage.Lot number: 50647767.Manufacturing date: 2012/02.Expiration date: 2015/02.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 18-mar-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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain ('severe (chronic) pain in the abdomen') and device breakage ('the foreign body material has been partly removed') in a female patient who had essure (batch no.50647767) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "the foreign body material has been partly removed".On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), back pain ("back pain"), arthralgia ("hips pain"), headache ("head pain"), fatigue ("extreme and chronic fatigue"), amnesia ("memory loss"), disturbance in attention ("concentration problems"), menstrual disorder ("menstrual cycle changed"), abnormal uterine bleeding ("abnormally heavy bleeding"), hypersensitivity ("allergic reactions") and mood swings ("mood swings") and was found to have hormone level abnormal ("hormonal problems").The patient was treated with surgery (removal of essure / partially removed).Essure was removed.At the time of the report, the abdominal pain, device breakage, back pain, arthralgia, headache, fatigue, amnesia, disturbance in attention, menstrual disorder, abnormal uterine bleeding, hormone level abnormal, hypersensitivity and mood swings outcome was unknown.The reporter provided no causality assessment for abnormal uterine bleeding, amnesia, arthralgia, back pain, disturbance in attention, fatigue, headache, hormone level abnormal, hypersensitivity, menstrual disorder and mood swings with essure.The reporter considered abdominal pain and device breakage to be related to essure.The reporter commented: various physical complaints developed after this treatment.Since then she had had follow-up treatments and the foreign body material was partly removed.She was hindered in her normal daily functioning and suffered damage.Lot number: 50647767, manufacturing date: 2012/02, and expiration date: 2015/02.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 11-mar-2022: adverse event "foreign material has been removed together with my uterus" changed to "severe (chronic) pain in the abdomen"; also "back pain", "hips pain", "head pain", "extreme and chronic fatigue", "memory loss", "concentration problems", "menstrual cycle changed", "abnormally heavy bleeding", "hormonal problems", "allergic reactions", "mood swings" added to the case; reporter 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.

• 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, NJ 07981
• MDR Report Key: 10020880
• MDR Text Key: 189745272
• Report Number: 2951250-2020-06645
• 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,Followup,Followup,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2012
• Device Model Number: ESS305
• Device Lot Number: 50647767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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; Other
• Patient Sex: Female