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

Model Number	ESS305
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Pain (1994); Uterine Perforation (2121); Anxiety (2328); Depression (2361); Abdominal Distention (2601); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of implant") and device breakage ("fracturing of the implant") in a female patient who received essure for sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient started essure.On an unknown date, the patient experienced device dislocation (serious criteria medically significant and clinically significant/intervention required), device breakage (serious criterion medically significant), pelvic pain ("pain"), abdominal distension ("bloating"), headache ("headaches"), anxiety ("anxiety") and depression ("depression").The patient was treated with surgery (hysterectomy performed on (b)(6) 2015).Essure was withdrawn.At the time of the report, the device dislocation, device breakage, pelvic pain, abdominal distension, headache, anxiety and depression outcome was unknown.The reporter considered device dislocation, device breakage, pelvic pain, abdominal distension, headache, anxiety and depression to be related to essure.Company causality comment: this non-medically confirmed spontaneous legal case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted.She had migration of implant (seen as device dislocation) and fracturing of the implant (seen as device breakage).A hysterectomy was performed to remove micro-inserts around 1 year and half after insertion.Both events are serious due to medical significance and anticipated in the reference safety information for essure.During essure therapy there is a risk that the device could move out of fallopian tubes; this movement could be a dislocation/ migration, or occur as a result of uterine perforation.In the present case, consumer presented migration of implant followed by surgical removal of device.Given the nature of event, a causal relationship with essure cannot be excluded.Regarding event device breakage, during difficult insertions and removals, single cases have been reported of essure breakage, in this case the mechanism of the device breakage is unknown.Given event's nature causality cannot be excluded this case was regarded as incident since device removal was required.A product technical analysis is being sought.Further information will be obtained through the litigation process.
Additional Manufacturer Narrative
(b)(4).Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There is the possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the medical events are not indicative of a quality deficit per se.Since no batch number was reported a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 6-jan-2017: ptc investigation result.Company causality comment: this non-medically confirmed spontaneous legal case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted.She had migration of implant (seen as device dislocation) and fracturing of the implant (seen as device breakage).A hysterectomy was performed to remove micro-inserts around 1 year and half after insertion.Both events are serious due to medical significance and anticipated in the reference safety information for essure.During essure therapy there is a risk that the device could move out of fallopian tubes; this movement could be a dislocation/ migration, or occur as a result of uterine perforation.In the present case, consumer presented migration of implant followed by surgical removal of device.Given the nature of event, a causal relationship with essure cannot be excluded.Regarding event device breakage, during difficult insertions and removals, single cases have been reported of essure breakage, in this case the mechanism of the device breakage is unknown.Given event's nature causality cannot be excluded this case was regarded as incident since device removal was required.According to the product technical analysis, product quality defect could not be confirmed but is considered plausible.Further information will be obtained through the litigation process.
Additional Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of implant") and device breakage ("fracturing of the implant") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), abdominal distension ("bloating"), headache ("headaches"), anxiety ("anxiety"), depression ("depression") and fatigue ("fatigue").The patient was treated with surgery (hysterectomy / surgery to removed essure device).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, device breakage, pelvic pain, abdominal distension, headache, anxiety, depression and fatigue outcome was unknown.The reporter considered abdominal distension, anxiety, depression, device breakage, device dislocation, fatigue, headache and pelvic pain to be related to essure.Quality-safety evaluation of ptc: ptc global number: (b)(4).Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There is the possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the medical events are not indicative of a quality deficit per se.Since no batch number was reported a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 14-nov-2017: summons received - new event 'fatigue' was added.Incident category of the event 'fracturing of the implant' was updated from 'other reportable incident' to 'incident'.Surgical treatment for the event 'fracturing of the implant' was added.Product implants date was updated.Reporter was added.¿essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4) and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only".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.
Additional Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of implant'), device breakage ('fracturing of the implant') and embedded device ('implants were completely embedded in the fallopian tube') in an adult female patient who had essure (batch no.B82402-inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included adenomyosis and uterine prolapse.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), abdominal distension ("bloating"), headache ("headaches"), anxiety ("anxiety"), depression ("depression") and fatigue ("fatigue").The patient was treated with surgery (she had surgery to remove the essure and hysterectomy / surgery to removed essure device).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, device breakage, embedded device, pelvic pain, abdominal distension, headache, anxiety, depression and fatigue outcome was unknown.The reporter considered abdominal distension, anxiety, depression, device breakage, device dislocation, embedded device, fatigue, headache and pelvic pain to be related to essure.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain.Quality-safety evaluation of ptc: ptc global number: (b)(4).Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There is the possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the medical events are not indicative of a quality deficit per se.Since no batch number was reported a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 18-sep-2020: update of information (batch is invalid).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.
Additional Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of implant'), device breakage ('fracturing of the implant') and embedded device ('implants were completely embedded in the fallopian tube') in an adult female patient who had essure (batch no.B82402-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included adenomyosis and uterine prolapse.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), abdominal distension ("bloating"), headache ("headaches"), anxiety ("anxiety"), depression ("depression") and fatigue ("fatigue").The patient was treated with surgery (she had surgery to remove the essure and hysterectomy / surgery to removed essure device).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, device breakage, embedded device, pelvic pain, abdominal distension, headache, anxiety, depression and fatigue outcome was unknown.The reporter considered abdominal distension, anxiety, depression, device breakage, device dislocation, embedded device, fatigue, headache and pelvic pain to be related to essure.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain.Lot number [ b82402 ] is not valid quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 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.
Additional Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of implant'), device breakage ('fracturing of the implant') and embedded device ('implants were completely embedded in the fallopian tube') in an adult female patient who had essure (batch no.B82402) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included adenomyosis and uterine prolapse.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), abdominal distension ("bloating"), headache ("headaches"), anxiety ("anxiety"), depression ("depression") and fatigue ("fatigue").The patient was treated with surgery (she had surgery to remove the essure and hysterectomy / surgery to removed essure device).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, device breakage, embedded device, pelvic pain, abdominal distension, headache, anxiety, depression and fatigue outcome was unknown.The reporter considered abdominal distension, anxiety, depression, device breakage, device dislocation, embedded device, fatigue, headache and pelvic pain to be related to essure.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain.Quality-safety evaluation of ptc: ptc global number: (b)(4).Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There is the possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the medical events are not indicative of a quality deficit per se.Since no batch number was reported a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 8-sep-2020: medical record received.Event added: the implants were completely embedded in the fallopian tube.Lot number, reporters information and medical history 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.

• Brand Name: ESSURE
• Common Device Name: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 6215742
• Report Number: 2951250-2016-02854
• Device Sequence Number: 665543
• Product Code: HHS
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESS305
• Device Lot Number: B82402-NOT VALID
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided; 11/14/2017; 09/08/2020; 09/18/2020; 09/24/2020
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 01/27/2017; 11/24/2017; 09/18/2020; 09/23/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention