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

Model Number ESS305

Device Problems Retraction Problem (1536); Separation Failure (2547); Patient-Device Incompatibility (2682)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/24/2017

Event Type  Injury  

Event Description

This spontaneous case was reported by a pharmacist and describes the occurrence of procedural haemorrhage ("tubal haemorrhage in consequence of extraction of introducer with stuck insert") in a female patient who had essure (batch no.He011pl) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced procedural haemorrhage (seriousness criteria medically significant and intervention required), device deployment issue ("it was impossible to withdraw the introducer when the insert was in the uterine tube, the insert remained stuck") and complication of device insertion ("device insertion failed").The patient was treated with surgery (bilateral salpingectomy by laparoscopic route on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the procedural haemorrhage, device deployment issue and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion, device deployment issue and procedural haemorrhage with essure.Most recent follow-up information incorporated above includes: on 3-apr-2017: significant correction: entry of company causality assessment.Company causality comment: this spontaneous pharmacist report refers to a female patient who had an attempt to have essure (fallopian tube occlusion inserts) inserted and experienced tubal hemorrhage in consequence of extraction of introducer with stuck insert (interpreted as procedural hemorrhage and deployment issue), resulting in bilateral salpingectomy by laparoscopic route.The procedural hemorrhage, serious due to medical significance, is anticipated in the reference safety information of essure.Procedural complications, including lesions or bleeding, may occur during any transcervical procedures, including the insertion of essure.In this particular case, the tubal hemorrhage was described to have resulted from an inserter issue, therefore the causality of the event was assessed as related.This case was classified as incident due to serious injury and intervention required.A product technical analysis and follow-up information are expected.

Manufacturer Narrative

This spontaneous case was reported by a pharmacist and describes the occurrence of procedural haemorrhage ("tubal haemorrhage in consequence of extraction of introducer with stuck insert") in a female patient who had essure (batch no.He011pl) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced procedural haemorrhage (seriousness criteria medically significant and intervention required), device deployment issue ("it was impossible to withdraw the introducer when the insert was in the uterine tube, the insert remained stuck") and complication of device insertion ("device insertion failed").The patient was treated with surgery (bilateral salpingectomy by laparoscopic route on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the procedural haemorrhage, device deployment issue and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion, device deployment issue and procedural haemorrhage with essure.Quality-safety evaluation of ptc: lot number he011pl, production date 15-jan-2016, expiration date 28-jan-2019 based on the technical assessment, lot number was provided therefore, the quality unit conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.The quality unit was unable to confirm any quality defect or device malfunction at this time.However, the quality unit cannot exclude the possibility of having a technical issue involved in the complaint.No capa investigation is required at this time because the possibility of a detachment difficulty event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.As a product quality defect could not be confirmed but is considered plausible, a relationship with the reported medical event cannot be totally excluded.However, the reported medical event is not indicative of a quality defect per se.Most recent follow-up information incorporated above includes: on 16-may-2017: quality-safety evaluation of ptc.Company causality comment: this spontaneous pharmacist report refers to a female patient who had an attempt to have essure (fallopian tube occlusion inserts) inserted and experienced tubal hemorrhage in consequence of extraction of introducer with stuck insert (interpreted as procedural hemorrhage and deployment issue), resulting in bilateral salpingectomy by laparoscopic route.The procedural hemorrhage, serious due to medical significance, is anticipated in the reference safety information of essure.Procedural complications, including lesions or bleeding, may occur during any transcervical procedures, including the insertion of essure.In this particular case, the tubal hemorrhage was described to have resulted from an inserter issue, therefore the causality of the event was assessed as related.This case was classified as incident due to serious injury and intervention required.According to the product technical analysis, a product quality defect could not be confirmed but is considered plausible.Follow-up information is expected.

Manufacturer Narrative

This case was initially received via regulatory authority ansm - heath authorities in france (reference number: (b)(4)) on (b)(6) 2017.The most recent information was received on (b)(6) 2017 this spontaneous case was reported by a pharmacist and describes the occurrence of procedural haemorrhage ("tubal haemorrhage in consequence of extraction of introducer with stuck insert") in a (b)(6) female patient who had essure (batch no.He011pl) inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 2 (two pregnancies and 2 deliveries (2 cesarean section)).No past medical history of ectopic pregnancy.No past medical history of elective abortion.No abnormal uterine findings prior to insertion.Previously administered products included for an unreported indication: mirena.Past adverse reactions to the above products included amenorrhoea with mirena.Concurrent conditions included general anesthesia on (b)(6) 2017.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced procedural haemorrhage (seriousness criteria medically significant and intervention required), device deployment issue ("it was not possible to remove the implant as it remained attached, it was not possible to release it") and complication of device insertion ("device insertion failed").The patient was treated with surgery (bilateral salpingectomy by laparoscopic route on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the procedural haemorrhage, device deployment issue and complication of device insertion had resolved.The reporter provided no causality assessment for complication of device insertion, device deployment issue and procedural haemorrhage with essure.The reporter commented: essure insertion was easy.Visualization of tubal os was easy, fluid loss during hysteroscopy was not more than 1500cc; the procedure did not take more than 20 min; patient had no complaints immediately after insertion.For mirena case please refer to case (b)(4).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30 kg/sqm.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on 21-jun-2017 for the following meddra preferred term: procedural haemorrhage.The analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Quality-safety evaluation of ptc: lot number he011pl, production date 15-jan-2016, expiration date 28-jan-2019 based on the technical assessment, lot number was provided therefore, the quality unit conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.The quality unit was unable to confirm any quality defect or device malfunction at this time.However, the quality unit cannot exclude the possibility of having a technical issue involved in the complaint.No capa investigation is required at this time because the possibility of a detachment difficulty event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.As a product quality defect could not be confirmed but is considered plausible, a relationship with the reported medical event cannot be totally excluded.However, the reported medical event is not indicative of a quality defect per se.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2017: medical history, patient information updated.Linked case report (mirena case).Insertion details updated.It was not possible to remove the implant as it remained attached, it was not possible to release it.Salpingectomy done by laparoscopy.Company causality comment: at the time of reporting, 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 pharmacist and describes the occurrence of procedural haemorrhage ("tubal haemorrhage in consequence of extraction of introducer with stuck insert") in a (b)(6) year-old female patient who had essure (batch no.(b)(4)) inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 2 (two pregnancies and 2 deliveries (2 cesarean section)).No past medical history of ectopic pregnancy.No past medical history of elective abortion.No abnormal uterine findings prior to insertion.Previously administered products included for an unreported indication: mirena.Past adverse reactions to the above products included amenorrhoea with mirena.Concurrent conditions included general anesthesia since (b)(6) 2017.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced procedural haemorrhage (seriousness criteria medically significant and intervention required), device deployment issue ("it was not possible to remove the implant as it remained attached, it was not possible to release it") and complication of device insertion ("device insertion failed").The patient was treated with surgery (bilateral salpingectomy by laparoscopic route on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the procedural haemorrhage, device deployment issue and complication of device insertion had resolved.The reporter provided no causality assessment for complication of device insertion, device deployment issue and procedural haemorrhage with essure.The reporter commented: essure insertion was easy.Visualization of tubal os was easy, fluid loss during hysteroscopy was not more than 1500cc; the procedure did not take more than 20 min; patient had no complaints immediately after insertion.For mirena case please refer to case (b)(4).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30 kg/sqm.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on 24-jul-2017 for the following meddra preferred term: procedural haemorrhage.The analysis in the global safety database revealed 24 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Quality-safety evaluation of ptc: based on the technical assessment, lot number was provided therefore, the quality unit conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.The returned sample was inspected.The quality unit was unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.The ptc investigation was conducted and the outcome resulted in unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 24-jul-2017: update of quality-safety evaluation of ptc.Sample received.Incident: at the time of reporting, 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 pharmacist and describes the occurrence of procedural haemorrhage ("tubal haemorrhage in consequence of extraction of introducer with stuck insert") in a 46-year-old female patient who had essure (batch no.He011pl) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "it was not possible to remove the implant as it remained attached, it was not possible to release it" on (b)(6) 2017 and wrong technique in device usage process "pqs: wrong technique in device usage process".The patient's past medical history included parity 2 (two pregnancies and 2 deliveries (2 cesarean section)).No past medical history of ectopic pregnancy.No past medical history of elective abortion.No abnormal uterine findings prior to insertion.Previously administered products included for an unreported indication: mirena.Past adverse reactions to the above products included amenorrhoea with mirena.Concurrent conditions included general anesthesia since (b)(6) 2017.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced procedural haemorrhage (seriousness criteria medically significant and intervention required) and complication of device insertion ("device insertion failed").The patient was treated with surgery (bilateral salpingectomy by laparoscopic route on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the procedural haemorrhage and complication of device insertion had resolved.The reporter provided no causality assessment for complication of device insertion and procedural haemorrhage with essure.The reporter commented: essure insertion was easy.Visualization of tubal os was easy, fluid loss during hysteroscopy was not more than 1500cc; the procedure did not take more than 20 min; patient had no complaints immediately after insertion.For mirena case please refer to case (b)(4).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 8-oct-2018: quality-safety evaluation of ptc.Incident: at the time of reporting, 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.

• 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: 6525541
• MDR Text Key: 73813104
• Report Number: 2951250-2017-01714
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: ESS305
• Device Catalogue Number: ESS305
• Device Lot Number: HE011PL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 74