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

Model Number ESS305

Device Problems Break (1069); Positioning Failure (1158); Difficult to Fold, Unfold or Collapse (1254); Separation Failure (2547); Activation Failure (3270)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is a solicited case report received from a gynecologist/obstetrician in (b)(6) on (b)(6) 2016 which refers to a female patient of unspecified age who was involved in a reimbursement or compensation activity, study number: (b)(6).Study description: (b)(6).On (b)(6) 2016 patient had an attempt to get essure (fallopian tube occlusion insert) inserted with lot number he011h6.It was reported that at the time of placement, difficulty to uncoil, implant did not deploy in fallopian tube.Release of a part of delivery catheter with implant occurred.Bilateral insertion was done with another essure system.Complete essure system was kept.Company causality comment: a female patient of unspecified age had an attempt to get essure (fallopian tube occlusion insert) inserted and at the time of placement, release of a part of delivery catheter with implant occurred.This event, regarded as device breakage, is considered anticipated according to the reference safety information for essure.In this particular case, the device breakage occurred during a difficult insertion procedure.The implant did not deploy in fallopian tube.Therefore, a causal relationship with essure cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Further information and product technical analysis are being sought.

Manufacturer Narrative

The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 21-dec-2016 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1462 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: (b)(4).Lot number he011h6 (production date 30-nov-2015, expiration date 28-nov-2018).As of nov 29, 2016, the rqu has not received returned product for this case.This case is being processed as if no product will be returned.Deployment difficulty is defined as a failure the micro-insert outer coils to expand from the wound down position.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper deployment: rollback to initial hard stop; depress button; perform final rollback.Under normal circumstances, when the physician completes the proper essure placement steps, the release ribbon should disengage from the platinum half band(welded onto outer coils of micro-insert).Once disengagement occurs, the outer coils should expand.If it does not, this is referred to deployment difficulty.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, it is possible the essure device could have been defective prior to removal from the package.The possibility of delivery catheter breakage and a deployment difficulty event are anticipated events and there was no event reported which indicates a new technical failure mode for the device.Based on the available information a product quality defect could not be confirmed but is considered plausible.Based on the provided information the defect type corresponds to the following meddra llt: device deployment issue and device breakage.Since no medical events were reported at this point in time, the assessment of a relationship with a quality defect, as well as, a batch investigation with respect to similar ae cases are not applicable.Most recent follow-up information incorporated above includes: on 19-dec-2016: quality safety evaluation of ptc.Company causality comment: a female patient of unspecified age had an attempt to get essure (fallopian tube occlusion insert) inserted and at the time of placement, the implant did not release in fallopian tube.This event, regarded as device breakage, is considered anticipated according to the reference safety information for essure.In this particular case, the device breakage occurred during a difficult insertion procedure.The implant did not release in fallopian tube.Therefore, a causal relationship with essure cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Based on the available information a product quality defect could not be confirmed but is considered plausible.No further information is expected.

Manufacturer Narrative

The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 03-feb-2017 for the following meddra preferred term: device damage.The analysis in the global safety database revealed 03 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: udi number - (b)(4) lot number he011h6 (production date 30-nov-2015, expiration date 28-nov-2018).Since product was returned 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, ifu steps were completed.Inner catheter and delivery wire bonds were cured, no damages were observed on delivery catheter, it was not observed a breakage on the catheter.Micro-insert was found damaged (bent inner coil section),no damages were observed on the half band.In regards of visual inspection of delivery wire holder bond, hypo-tube to handle bond and the ptfe liner area were in conformance with acceptance criteria per inspection process.For dimensional inspection the length of the inner catheter was in compliance with acceptance criteria as per inspection process.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, it is possible the essure device could have been defective prior to removal from the package.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 deployment difficulty and detachment difficulty event are an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the available information a product quality defect could not be confirmed but is considered plausible.Based on the provided information the defect type corresponds to the following meddra llt: device damage and device deployment issue.Since no medical events were reported at this point in time, the assessment of a relationship with a quality defect, as well as, a batch investigation with respect to similar ae cases are not applicable.Most recent follow-up information incorporated above includes: on 31-jan-2017: quality safety evaluation of ptc.Event release of a part of delivery catheter with implant (breakage diagnosed during placement) was updated to micro-insert was found damaged (bent inner coil section).Company causality comment: a (b)(6) female patient had an attempt to get essure (fallopian tube occlusion insert) inserted and it was reported that micro-insert was found damaged (bent inner coil section) upon receipt of product technical complaint.Therefore, the previous event release of a part of delivery catheter with implant (breakage diagnosed during placement) was deleted.The event micro-insert was found damaged is considered unanticipated according to the reference safety information for essure.According to the product technical complaint, no damages were observed on delivery catheter and it was not observed a breakage on the catheter.It is possible the essure device could have been defective prior to removal from the package.However, as it is not clear and considering that the device damage occurred during a difficult insertion procedure, a causal relationship with essure insertion cannot be excluded.This case was regarded as other reportable incident due to the device damage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Based on the available information a product quality defect could not be confirmed but is considered plausible.No further information is expected.

Manufacturer Narrative

This 38-year-old female patient was involved in a reimbursement or compensation activity.The patient had essure (batch no.He011h6) inserted.The report describes a case of complication of device insertion ("release of a part of delivery catheter with implant").Other product or product use issues identified: device deployment issue "at the time of placement, difficulty to uncoil, implant did not release in fallopian tube" on (b)(6) 2016 and device damage "micro-insert was found damaged (bent inner coil section)".On (b)(6) 2016, the patient had essure inserted.On the same day, the patient experienced complication of device insertion.At the time of the report, the complication of device insertion outcome was unknown.The relationship of complication of device insertion to treatment with essure was not reported.The reporter commented: bilateral insertion was done with another essure system.Complete essure system was kept.The device is available.Product use recommendations were followed and patient did not have any lesions.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 19-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.

Manufacturer Narrative

This 38-year-old female patient was involved in a reimbursement or compensation activity.The patient had essure (batch no.He011h6) inserted.The report describes a case of complication of device insertion ("release of a part of delivery catheter with implant").Other product or product use issues identified: device deployment issue "at the time of placement, difficulty to uncoil, implant did not release in fallopian tube" on (b)(6) 2016 and device damage "micro-insert was found damaged (bent inner coil section)".On (b)(6) 2016, the patient had essure inserted.On the same day, the patient experienced complication of device insertion.At the time of the report, the complication of device insertion outcome was unknown.The relationship of complication of device insertion to treatment with essure was not reported.The reporter commented: bilateral insertion was done with another essure system.Complete essure system was kept.The device is available.Product use recommendations were followed and patient did not have any lesions.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-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, CA 13353 ; GM 13353
• MDR Report Key: 6125515
• MDR Text Key: 61101666
• Report Number: 2951250-2016-02581
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Model Number: ESS305
• Device Lot Number: HE011H6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR