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

BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Positioning Failure (1158); Difficult to Insert (1316); Separation Failure (2547); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 02/06/2017

Event Type Injury

Event Description

Manufacturer Narrative

Quality-safety evaluation of ptc: lot e36577 production date: 15-oct-2015 expiration date: 28-oct-2018.As of 16-mar-2017, the rqu (responsible quality unit) has not received returned product for this case.This case is being processed as if no product will be returned.If product is received by rqu in the future, a child case will be opened and an investigation will be completed on the returned device.Several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the inserts grip on the delivery wire, and potential manufacturing deficiencies.We 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.We are 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.The possibility of detachment difficulty and a micro-insert breakage event are anticipated events 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 and device deployment issue.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events are known, possible, undesirable event and not indicative of a quality deficit per se.No further ae case reports have been received to date in relation to the reported batch.Most recent follow-up information incorporated above includes: on 21-mar-2017: quality-safety evaluation of product technical complaint was received.Company causality comment: this spontaneous medically confirmed case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and during the procedure, on the right side the internal coil was retrieved but the external coil remained in place (interstitial segment).The next day she was submitted to a surgical procedure, the outer coil was not visualized on either laparoscopy or hysteroscopy, as it had gone up into the interstitial segment of uterine tube.These events, regarded as device breakage and device dislocation into the fallopian tube, are anticipated in the reference safety information for essure.In the present case, considering the events occurred in close association with essure insertion procedure, causality with the suspect insert cannot be excluded.This case was regarded as incident since a surgical intervention was required.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.No further ae case reports have been received to date in relation to the reported batch.No further information is expected.

Manufacturer Narrative

This spontaneous case was reported by a pharmacist and describes the occurrence of device breakage ("internal coil was retrieved but the external coil remained in place (interstitial segment)") and device dislocation ("the outer coil was not visualised on either laparoscopy or hysteroscopy as it had gone up into the interstitial segment of uterine tube") in a (b)(6) female patient who had essure (batch no.E36577) 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 device breakage (seriousness criteria medically significant and intervention required), device deployment issue ("non-release of right tube implant"), the first episode of complication of device insertion ("no bilateral insertion- procedure was stopped") and the second episode of complication of device insertion ("complication of device insertion").On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (laparoscopy on (b)(6) 2017.Tubal sterilisation and ablation of essure insert on left) and surgery.Essure treatment was not changed.At the time of the report, the device breakage, device deployment issue and the last episode of complication of device insertion had resolved and the device dislocation had not resolved.The reporter provided no causality assessment for device breakage, device deployment issue, device dislocation, the first episode of complication of device insertion and the second episode of complication of device insertion with essure.The reporter commented: device damage was discovered during essure placement via hysteroscopy; inner coil and outer coil of insert were damaged.There was no anatomical reason for the problem.On right release catheter was not working (the problem was with the delivery handle - thumbwheel, release button - and the catheter).The inner coil got pulled out.The outer coil remained in the uterine tube (interstitial segment) after breakage of the bond between the inner and outer coils.Placement on left was normal.The next day, the outer coil of right insert was not visualized on either laparoscopy or hysteroscopy; due to it the outer coil was not removed.Outer coil of insert on right was left in place in the interstitial segment.According to the reporting physician the instructions for use were respected and there was no deviation from the placement procedure.Patient was not injured.Outcome as concerns damage and accompanying condition was regarded as recovered.The damaged device was sent to bayer diagnostic results: (b)(6) 2017: laparoscopy.Procedure performed: bipolar electrocoagulation and severing of proximal segment of right uterine tube, the outer coil of the essure insert was not visualized.On the left, ablation of essure insert was performed after salpingectomy, and then electrocoagulation and complete severing of proximal segment of tube.Conclusion: tubal sterilization on laparoscopy and ablation of essure insert on left.Outer coil of insert on right was left in place in the interstitial segment.Diagnostic hysteroscopy: outer coil not visualized on right as it had gone up into the interstitial segment of uterine tube.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 09-may-2017 for the following meddra preferred terms: 1.Device breakage.The analysis in the global safety database revealed (b)(4) cases.2.Device dislocation.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 these meddra pts.Quality-safety evaluation of ptc: lot e36577 production date: 15-oct-2015 expiration date: 28-oct-2018.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.Visual inspection was performed and it was confirmed that all components are present, all ifu steps were completed (pic1), inner catheter and delivery wire bonds were cured, damages were observed on delivery catheter specifically in inner catheter (stretched) (pic2), the micro-insert was not returned for investigation and it was not present as part of the delivery catheter.Due to device conditions.Dimensions were not able to be performed.No damages were observed on the button and wheel(pic3) since the micro insert was no returned for investigation we can conduct an investigation to confirm the breakage in the insert therefore this ease is unconfirmed quality defect but plausible.We are 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.We also 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 possibility of a detachment difficulty and a micro insert breaking event are 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.A product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded, but the reported medical event is not indicative of a quality deficit per se.No further ae case reports have been received in relation to the reported batch.Most recent follow-up information incorporated above includes: on 4-may-2017: updated quality safety evaluation of ptc company causality comment this spontaneous medically confirmed case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and during the procedure, on the right side the internal coil was retrieved but the external coil remained in place (interstitial segment).The next day she was submitted to a surgical procedure, the outer coil was not visualized on either laparoscopy or hysteroscopy, as it had gone up into the interstitial segment of uterine tube.These events, regarded as device breakage and device dislocation into the fallopian tube, are anticipated in the reference safety information for essure.In the present case, considering the events occurred in close association with essure insertion procedure, causality with the suspect insert cannot be excluded.This case was regarded as incident since a surgical intervention was required.According to the updated product technical analysis, a product quality defect could not be confirmed but is considered plausible.No further information is expected.

Manufacturer Narrative

This spontaneous case was reported by a pharmacist and describes the occurrence of device breakage ("internal coil was retrieved but the external coil remained in place (interstitial segment)") and device dislocation ("the outer coil was not visualised on either laparoscopy or hysteroscopy as it had gone up into the interstitial segment of uterine tube") in a 39-year-old female patient who had essure (batch no.E36577) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "non-release of right tube implant" on (b)(6) 2017.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage (seriousness criteria medically significant and intervention required), the first episode of complication of device insertion ("no bilateral insertion- procedure was stopped") and the second episode of complication of device insertion ("complication of device insertion").On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (laparoscopy on (b)(6) 2017.Tubal sterilisation and ablation of essure insert on left) and surgery.Essure treatment was not changed.At the time of the report, the device breakage and the last episode of complication of device insertion had resolved and the device dislocation had not resolved.The reporter provided no causality assessment for device breakage, device dislocation, the first episode of complication of device insertion and the second episode of complication of device insertion with essure.The reporter commented: device damage was discovered during essure placement via hysteroscopy; inner coil and outer coil of insert were damaged.There was no anatomical reason for the problem.On right release catheter was not working (the problem was with the delivery handle - thumbwheel, release button - and the catheter).The inner coil got pulled out.The outer coil remained in the uterine tube (interstitial segment) after breakage of the bond between the inner and outer coils.Placement on left was normal.The next day, the outer coil of right insert was not visualized on either laparoscopy or hysteroscopy; due to it the outer coil was not removed.Outer coil of insert on right was left in place in the interstitial segment.According to the reporting physician the instructions for use were respected and there was no deviation from the placement procedure.Patient was not injured.Outcome as concerns damage and accompanying condition was regarded as recovered.The damaged device was sent to bayer diagnostic results: (b)(6) 2017 laparoscopy.Procedure performed: bipolar electrocoagulation and severing of proximal segment of right uterine tube, the outer coil of the essure insert was not visualized.On the left, ablation of essure insert was performed after salpingectomy, and then electrocoagulation and complete severing of proximal segment of tube.Conclusion: tubal sterilization on laparoscopy and ablation of essure insert on left.Outer coil of insert on right was left in place in the interstitial segment.Diagnostic hysteroscopy: outer coil not visualized on right as it had gone up into the interstitial segment of uterine tube.Quality-safety evaluation of ptc: unable to confirm complaint several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the inserts grip on the delivery wire, and potential manufacturing deficiencies.We are 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.We also 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.No capa investigation is required at this time because the possibility of a detachment difficulty and a micro insert breaking event are 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.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on (b)(6) 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.

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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

6398621

MDR Text Key

69755047

Report Number

2951250-2017-00836

Device Sequence Number

Product Code

HHS

Combination Product (y/n)

PMA/PMN Number

P020014

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

foreign,health professional,o

Type of Report

Initial,Followup,Followup,Followup

Report Date

11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

03/13/2017

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Health Professional

Device Expiration Date

10/28/2018

Device Model Number

ESS305

Device Lot Number

E36577

Was Device Available for Evaluation?

Yes

Was the Report Sent to FDA?

Date Manufacturer Received

11/06/2018

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention;

Patient Age

39 YR

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

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