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

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Separation Failure (2547)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of device use error ("almost received broken essure trochar end of another patient / piece was released when used for insertion") in a female patient who received essure (batch no.E25516).On (b)(6) 2017, the patient started essure.On (b)(6) 2017, the patient experienced device use error.The reporter commented: the part of the device did not detach during insertion in another procedure and got blocked and remained inside even after cleaning according to company manual with blowing.It was then aspirated from the medical device during the extraction of a foreign body from this patient; it was released when used in this patient.Most recent follow-up information incorporated above includes: on 24-feb-2017: date of incident reported by the (b)(6): 08-jan-2017 ((b)(4)).Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and she almost received broken essure trochar end of another patient because piece was released when used during insertion procedure.This event, interpreted as wrong technique in device usage process, is unanticipated in the reference safety information for essure.In the present case, part of the device did not detach during a previous insertion procedure in another patient and got blocked and remained inside of hysteroscope, even after cleaning according to company manual.Then, the broken part was released when used in this patient.Given the nature of this event, causality with essure cannot be excluded.This case was regarded as other reportable incident, as although the mentioned event did not lead to death or serious health deterioration, this might have occurred under less fortunate circumstances.The product technical analysis and further information has been sought.

Manufacturer Narrative

Quality-safety evaluation of ptc: lot number e25516 (production date 17-sep-2015, expiration date 28-sep-2018).The broken part of introducer is not clear to confirm the breakage, since the sample was not returned for investigation this case is an unconfirmed quality defect but plausible.Sample not available.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 damage or breakage of the introducer is 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: wrong technique in device usage.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 7-mar-2017: quality-safety evaluation of ptc.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and she almost received broken essure trochar end of another patient because piece was released when used during insertion procedure.This event, interpreted as wrong technique in device usage process, is unanticipated in the reference safety information for essure.In the present case, part of the device did not detach during a previous insertion procedure in another patient and got blocked and remained inside of hysteroscope, even after cleaning according to company manual.Then, the broken part was released when used in this patient.Given the nature of this event, causality with essure cannot be excluded.This case was regarded as other reportable incident, as although the mentioned event did not lead to death or serious health deterioration, this might have occurred under less fortunate circumstances.The product technical analysis concluded a quality defect was not confirmed but considered plausible.Further information has been sought.

Manufacturer Narrative

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of device use error ("almost received broken essure trochar end of another patient / piece was released when used for insertion") in a female patient who had essure (batch no.E25516) inserted.On (b)(6) 2017, the patient had essure inserted.On (b)(6) 2017, the patient experienced device use error.The reporter commented: the part of the device did not detach during insertion in another procedure and got blocked and remained inside even after cleaning according to company manual with blowing.It was then aspirated from the medical device during the extraction of a foreign body from this patient; it was released when used in this patient.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred terms.In this particular case, a search in the database was performed on (b)(6) 2017 for the following meddra preferred term: device use error: 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 e25516 (production date 17-sep-2015, expiration date 28-sep-2018).The broken part of introducer is not clear to confirm the breakage, since the sample was not returned for investigation this case is an unconfirmed quality defect but plausible.Sample not available.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 damage or breakage of the introducer is 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: wrong technique in device usage.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 11-apr-2017: addition of device similar incident report.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and she almost received broken essure trochar end of another patient because piece was released when used during insertion procedure.This event, interpreted as wrong technique in device usage process, is unanticipated in the reference safety information for essure.In the present case, part of the device did not detach during a previous insertion procedure in another patient and got blocked and remained inside of hysteroscope, even after cleaning according to company manual.Then, the broken part was released when used in this patient.Given the nature of this event, causality with essure cannot be excluded.This case was regarded as other reportable incident, as although the mentioned event did not lead to death or serious health deterioration, this might have occurred under less fortunate circumstances.The product technical analysis concluded a quality defect was not confirmed but considered plausible.Despite several follow-up attempts, no further information could be obtained.

Manufacturer Narrative

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of device use error ("almost received broken essure trochar end of another patient / piece was released when used for insertion") in a female patient who had essure (batch no.E25516) inserted.On (b)(6) 2017, the patient had essure inserted.On (b)(6) 2017, the patient experienced device use error.The reporter commented: the part of the device did not detach during insertion in another procedure and got blocked and remained inside even after cleaning according to company manual with blowing.It was then aspirated from the medical device during the extraction of a foreign body from this patient; it was released when used in this patient.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred terms.In this particular case a search in the database was performed on 17-apr-2017 for the following meddra preferred term: device use error: the analysis in the global safety database revealed 65 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 e25516 (production date 17-sep-2015, expiration date 28-sep-2018).The broken part of introducer is not clear to confirm the breakage, since the sample was not returned for investigation this case is an unconfirmed quality defect but plausible.Sample not available.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 damage or breakage of the introducer is 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: wrong technique in device usage.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 11-apr-2017: despite several attempts to acquire follow-up information, none received.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and she almost received broken essure trochar end of another patient because piece was released when used during insertion procedure.This event, interpreted as wrong technique in device usage process, is unanticipated in the reference safety information for essure.In the present case, part of the device did not detach during a previous insertion procedure in another patient and got blocked and remained inside of hysteroscope, even after cleaning according to company manual.Then, the broken part was released when used in this patient.Given the nature of this event, causality with essure cannot be excluded.This case was regarded as other reportable incident, as although the mentioned event did not lead to death or serious health deterioration, this might have occurred under less fortunate circumstances.The product technical analysis concluded a quality defect was not confirmed but considered plausible.Despite several follow-up attempts, no further information could be obtained.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: r1702203) on 03-feb-2017.The most recent information was received on 24-oct-2018.This spontaneous case was reported by a gynecologist and describes the occurrence of wrong technique in device usage process ("almost received broken essure trochar end of another patient / piece was released when used for insertion") in a female patient who had essure (batch no.E25516) inserted.On (b)(6)2017, the patient had essure inserted.On (b)(6) 2017, the patient experienced wrong technique in device usage process.The reporter commented: the part of the device did not detach during insertion in another procedure and got blocked and remained inside even after cleaning according to company manual with blowing.It was then aspirated from the medical device during the extraction of a foreign body from this patient; it was released when used in this patient.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 24-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: 6364437
• MDR Text Key: 69017060
• Report Number: 2951250-2017-00728
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: ESS305
• Device Lot Number: E25516
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1