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

Model Number ESS305

Device Problems Bent (1059); Break (1069); Difficult to Insert (1316); Separation Failure (2547); Physical Property Issue (3008); Device Handling Problem (3265)

Patient Problems Failure of Implant (1924); Muscle Spasm(s) (1966); No Code Available (3191)

Event Type  malfunction  

Event Description

This case was reported by a nurse and describes the occurrence of device deployment issue ("release of the first insert was impossible"), device physical property issue ("distal extremity of the second insert was bent"), fallopian tube spasm ("spasm during insertion of the second insert") and complication of device insertion ("spasm during insertion of the second insert") in a female patient who had essure (batch no.Cs000hw / he011dz) inserted.Other product or product use issues identified: device damage "device damage" on (b)(6) 2016.On (b)(6) 2016, the patient had essure inserted.On the same day, the patient experienced device deployment issue, device physical property issue, fallopian tube spasm and complication of device insertion.On (b)(6) 2016, the device deployment issue and complication of device insertion had resolved.At the time of the report, the device physical property issue and fallopian tube spasm outcome was unknown.The reporter considered complication of device insertion, device deployment issue, device physical property issue and fallopian tube spasm to be not reported (study) to essure.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 23-may-2017 for the following meddra preferred term: device damage.The analysis in the global safety database revealed 5 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: since samples were returned to us for investigation, we were able to conduct an investigation of the actual devices involved in this complaint.System 1: 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, damages were observed in the delivery catheter(coil catheter section broken).The half band of micro-insert was found stuck with the wound coils, therefore the micro-insert can't be released from the system, the rest of micro-insert was found bent.The release ribbon was observed broken.However the solder joints were in conformance with acceptance criteria per inspection process.Based on the observations mentioned from this failure is a confirmed quality defect that will need to be addressed through a capa investigation.System 2: visual inspection was performed and it was confirmed that all components are present, ifu steps were not initiated, inner catheter and delivery wire bonds were cured, no damage was presented in the delivery catheter, the micro-insert was found bent however based on complaint as reported, distal extremity of the second insert was bent due to spasm during insertion therefore there is no confirmed quality defect for the system 2.We also conducted a review of the manufacturing batches records and confirmed that final products testing for this lots were performed per requirements and the products met all release requirements.Based on the provided information the defect type corresponds to the following meddr llt: device shape alteration and device damage.As a product quality defect was confirmed a relationship with the reported medical event cannot be totally excluded.A review of similar cases for batch cs000hw resulted in no unusual pattern identified.No further ae case reports have been received to date in relation to the reported batch he011dz.Most recent follow-up information incorporated above includes:on 25-apr-2017: quality safety evaluation of ptc.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had an attempt of essure (fallopian tube occlusion insert) insertion and during the procedure the release of the first insert was impossible.A second insert was attempted to be placed but the distal extremity of this second insert was bent.Spasm was also noticed during placement attempt of this second insert.These events are anticipated according to essure's reference safety information.Since 2 samples were returned for investigation, the company was able to conduct an investigation of the actual devices involved in this complaint.In one sample, damages were observed in the delivery catheter and the half band of micro-insert was found stuck with the wound coils, therefore the micro-insert can't be released from the system, the rest of micro-insert was found bent.The release ribbon was observed broken.In the second sample, the micro-insert was found bent.The analysis concluded to a confirmed quality defect.As a product quality defect was confirmed a relationship with the reported medical event cannot be totally excluded.This case was regarded as other reportable incident, as although the reported events did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.

Manufacturer Narrative

This female patient was involved in a reimbursement or compensation activity.The patient had essure (batch no.(b)(4) inserted.The report describes a case of device deployment issue ("release of the first insert was impossible"), fallopian tube spasm ("spasm during insertion of the second insert") and complication of device insertion ("spasm during insertion of the second insert").Other product or product use issues identified: device physical property issue "distal extremity of the second insert was bent" on (b)(6) 2016 and device damage "device damage" on (b)(6) 2016.On (b)(6) 2016, the patient had essure inserted.On the same day, the patient experienced device deployment issue, fallopian tube spasm and complication of device insertion.On (b)(6) 2016, the device deployment issue and complication of device insertion had resolved.At the time of the report, the fallopian tube spasm outcome was unknown.The relationship of complication of device insertion, device deployment issue and fallopian tube spasm to treatment with essure was not reported.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 28-jul-2017 for the following meddra preferred term: device damage.The analysis in the global safety database revealed 7 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.Lot number: cs000hw manufacturing date: 2015/01 expiration date: 2017-10-31 lot number: he011dz manufacturing date: 2015-11-03 expiration date: 2018-11-28.Quality-safety evaluation of ptc: since samples were returned to us for investigation, we were able to conduct an investigation of the actual devices involved in this complaint.System1: 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, damages were observed in the delivery catheter(coil catheter section broken).The half band of micro-insert was found stuck with the wound coils, therefore the micro-insert can't be released from the system, the rest of micro-insert was found bent.The release ribbon was observed broken.However the solder joints were in conformance with acceptance criteria per inspection process.Based on the observations mentioned from this failure is a confirmed quality defect that will need to be addressed through a capa investigation.System2: visual inspection was performed and it was confirmed that all components are present, ifu steps were not initiated, inner catheter and delivery wire bonds were cured, no damage was presented in the delivery catheter, the micro-insert was found bent however based on complaint as reported, distal extremity of the second insert was bent due to spasm during insertion therefore there is no confirmed quality defect for the system 2.We also conducted a review of the manufacturing batches records and confirmed that final products testing for this lots were performed per requirements and the products met all release requirements.Based on the provided information the defect type corresponds to the following meddra llt: device shape alteration and device damage.As a product quality defect was confirmed a relationship with the reported medical event cannot be totally excluded.A review of similar cases for batch (b)(4) resulted in no unusual pattern identified.No further ae case reports have been received to date in relation to the reported batch (b)(4).Most recent follow-up information incorporated above includes: on 27-jul-2017: updated 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 female patient was involved in a reimbursement or compensation activity.The patient had essure (batch nos: cs000hw and he011dz) inserted.The report describes a case of fallopian tube spasm ("spasm during insertion of the second insert") and complication of device insertion ("spasm during insertion of the second insert").Other product or product use issues identified: device deployment issue "release of the first insert was impossible" on 14-oct-2016, device damage "device damage" on 14-oct-2016 and device physical property issue "distal extremity of the second insert was bent" on 14-oct-2016.On (b)(6) 2016, the patient had essure inserted and removed on an unknown date.A new essure was inserted on (b)(6) 2016.On the same day, the patient experienced fallopian tube spasm and complication of device insertion.On (b)(6) 2016, the complication of device insertion had resolved.At the time of the report, the fallopian tube spasm outcome was unknown.The relationship of complication of device insertion and fallopian tube spasm to treatment with essure was not reported.Lot number: cs000hw, manufacturing date: 2015/01, expiration date: 2017-10-31.Lot number: he011dz, manufacturing date: 2015-11-03, expiration date: 2018-11-28.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-oct-2018: update of quality-safety evaluation of ptc ( fda code update, ptc global number update).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: 6585486
• MDR Text Key: 76137659
• Report Number: 2951250-2017-01987
• 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
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: CS000HW / HE011DZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1