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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("coil is broken / floating fragments in tube"), device dislocation ("left coil is stabbing kidney") and adverse event ("100 side effects") in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant) and adverse event (seriousness criterion disability).At the time of the report, the device breakage, device dislocation and adverse event outcome was unknown.The reporter considered adverse event, device breakage and device dislocation to be related to essure.The reporter commented: consumer stated that she is handicapped from essure.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('coil is broken / floating fragments in tube'), device dislocation ('left coil is stabbing kidney'), adverse drug reaction ('100 side effects'), abortion spontaneous ('miscarriage') and pregnancy with contraceptive device ('miscarraige') in a female patient who had essure inserted.Other product or product use issues identified: device ineffective "device ineffective".On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), adverse drug reaction (seriousness criterion disability) and abortion spontaneous (seriousness criterion medically significant) and was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).At the time of the report, the device breakage, device dislocation, adverse drug reaction, abortion spontaneous and pregnancy with contraceptive device outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, adverse drug reaction, device breakage, device dislocation and pregnancy with contraceptive device to be related to essure.The reporter commented: consumer stated that she is handicapped from essure.Plaintiff experienced another miscarriage captured in case no: (b)(4) quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: all source document information, reporter and reference section from deletion case (b)(4) added to this case.New event "pregnancy with contraceptive device, miscarriage and device ineffective" was added incident no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances 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 device breakage ("coil is broken / floating fragments in tube"), device dislocation ("left coil is stabbing kidney") and adverse drug reaction ("100 side effects") in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant) and adverse drug reaction (seriousness criterion disability).At the time of the report, the device breakage, device dislocation and adverse drug reaction outcome was unknown.The reporter considered adverse drug reaction, device breakage and device dislocation to be related to essure.The reporter commented: consumer stated that she is handicapped from essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 31-oct-2018: quality safety evaluation of ptc.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('coil is broken / floating fragments in tube'), device dislocation ('left coil is stabbing kidney') and adverse drug reaction ('100 side effects') in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant) and adverse drug reaction (seriousness criterion disability).At the time of the report, the device breakage, device dislocation and adverse drug reaction outcome was unknown.The reporter considered adverse drug reaction, device breakage and device dislocation to be related to essure.The reporter commented: consumer stated that she is handcapped from essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-nov-2019: quality-safety evaluation of ptc.Incident: no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances 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 device breakage ('coil is broken / floating fragments in tube/ left coil is broken'), device dislocation ('left coil is stabbing kidney'), adverse drug reaction ('109 side effects'), abortion spontaneous ('miscarriage') and pregnancy with contraceptive device ('miscarriage') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".In (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), adverse drug reaction (seriousness criterion disability), abortion spontaneous (seriousness criterion medically significant), alopecia ("losing hair"), abdominal distension ("e-belly") and back pain ("back pain") and was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).At the time of the report, the device breakage, device dislocation, adverse drug reaction, abortion spontaneous, pregnancy with contraceptive device, alopecia, abdominal distension and back pain outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, abortion spontaneous, adverse drug reaction, alopecia, back pain, device breakage, device dislocation and pregnancy with contraceptive device to be related to essure.The reporter commented: consumer stated that she is handcapped from essure.Plaintiff experienced another miscarriage captured in case no: (b)(4).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media content received: reporter added.Event losing hair was added.On 20-mar-2020: social media content received: reporter added.Fu 5 and 6 processed together.On 20-mar-2020: fu 7, 8, 9,10, 11 processed together.Social media content received : reporters added.Event added- abdominal distension.Information from duplicate deleted cases 2019-227324 merged with this case.All source documents, reference information and reporters information was transferred.In addition, event ¿back pain¿ was added from the duplicate case.On 20-mar-2020: processed with fu 7.On 20-mar-2020: processed with fu 7.On 20-mar-2020: processed with fu 7.On 20-mar-2020: processed with fu 7.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 device breakage ('coil is broken / floating fragments in tube/ left coil is broken'), device dislocation ('left coil is stabbing kidney'), adverse drug reaction ('109 side effects'), abortion spontaneous ('miscarriage') and pregnancy with contraceptive device ('miscarriage') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".In (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), adverse drug reaction (seriousness criterion disability), abortion spontaneous (seriousness criterion medically significant), alopecia ("losing hair"), abdominal distension ("e-belly") and back pain ("back pain") and was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).At the time of the report, the device breakage, device dislocation, adverse drug reaction, abortion spontaneous, pregnancy with contraceptive device, alopecia, abdominal distension and back pain outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, abortion spontaneous, adverse drug reaction, alopecia, back pain, device breakage, device dislocation and pregnancy with contraceptive device to be related to essure.The reporter commented: consumer stated that she is handicapped from essure.Plaintiff experienced another miscarriage captured in case no: (b)(4).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-apr-2020: 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
• MDR Report Key: 7642303
• MDR Text Key: 112486684
• Report Number: 2951250-2018-02862
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability