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

Model Number ESS305

Device Problems Break (1069); Separation Failure (2547)

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

Event Type  malfunction  

Event Description

This female patient was involved in a reimbursement or compensation activity.The patient had essure (batch no.He011p5) inserted.The report describes a case of device breakage ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium"), complication of device insertion ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium") and device deployment issue ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium").On (b)(6) 2017, the patient had essure inserted.On (b)(6) 2017, the patient experienced device breakage, complication of device insertion and device deployment issue.Essure treatment was not changed.At the time of the report, the device breakage, complication of device insertion and device deployment issue outcome was unknown.The relationship of complication of device insertion, device breakage and device deployment issue to treatment with essure was not reported.The reporter commented: essure insertion was easily performed on right side with 5 trailing coils.On removal of delivery catheter on left side, numerous released coils were pulled and remained attached to delivery catheter whereas essure insert remained placed in ostium with 5 visible trailing coils.Insertion failure was not considered as essure insert remained placed.Bilateral insertion was performed.The pharmacist confirmed that they did not know if a breakage occurred but that it was possible.They had the impression that there were two inserts but she did not know if it was inner and outer coils of the essure insert.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 29-jun-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1.642 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.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 female patient was involved in a reimbursement or compensation activity.The patient had essure (batch no.He011p5) inserted.The report describes a case of device breakage ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium"), complication of device insertion ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium") and device deployment issue ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium").On (b)(6) 2017, the patient had essure inserted.On (b)(6) 2017, the patient experienced device breakage, complication of device insertion and device deployment issue.Essure treatment was not changed.At the time of the report, the device breakage, complication of device insertion and device deployment issue outcome was unknown.The relationship of complication of device insertion, device breakage and device deployment issue to treatment with essure was not reported.The reporter commented: essure insertion was easily performed on right side with 5 trailing coils.On removal of delivery catheter on left side, numerous released coils were pulled and remained attached to delivery catheter whereas essure insert remained placed in ostium with 5 visible trailing coils.Insertion failure was not considered as essure insert remained placed.Bilateral insertion was performed.The pharmacist confirmed that they did not know if a breakage occurred but that it was possible.They had the impression that there were two inserts but she did not know if it was inner and outer coils of the essure insert.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 01-aug-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1.664 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.Most recent follow-up information incorporated above includes: on 1-aug-2017: 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 (b)(6) year-old female patient was involved in a reimbursement or compensation activity.The patient had essure (batch no.He011p5) inserted.The report describes a case of device breakage ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium"), complication of device insertion ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium") and device deployment issue ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium").On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, complication of device insertion and device deployment issue.Essure treatment was not changed.At the time of the report, the device breakage was resolving and the complication of device insertion and device deployment issue outcome was unknown.The relationship of complication of device insertion, device breakage and device deployment issue to treatment with essure was not reported.The reporter commented: essure insertion was easily performed on right side with 5 trailing coils.On removal of delivery catheter on left side, numerous released coils were pulled and remained attached to delivery catheter whereas essure insert remained placed in ostium with 5 visible trailing coils.Insertion failure was not considered as essure insert remained placed.Bilateral insertion was performed.The pharmacist confirmed that they did not know if a breakage occurred but that it was possible.They had the impression that there were two inserts but she did not know if it was inner and outer coils of the essure insert.Essure ifu was followed, all broken pieces were retrieved.Broken pieces were removed.No was the answered when asked if essure was removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 22.4 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-aug-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1.689 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.Most recent follow-up information incorporated above includes: on 21-aug-2017: device breakage questionnaire received.Patient initials, age, weight and height added.Event outcome updated.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 (b)(6) year-old female patient was involved in a reimbursement or compensation activity.The patient had essure (batch no.He011p5) inserted.The report describes a case of device breakage ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium"), complication of device insertion ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium") and device deployment issue ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium").On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, complication of device insertion and device deployment issue.Essure treatment was not changed.At the time of the report, the device breakage was resolving and the complication of device insertion and device deployment issue outcome was unknown.The relationship of complication of device insertion, device breakage and device deployment issue to treatment with essure was not reported.The reporter commented: essure insertion was easily performed on right side with 5 trailing coils.On removal of delivery catheter on left side, numerous released coils were pulled and remained attached to delivery catheter whereas essure insert remained placed in ostium with 5 visible trailing coils.Insertion failure was not considered as essure insert remained placed.Bilateral insertion was performed.The pharmacist confirmed that they did not know if a breakage occurred but that it was possible.They had the impression that there were two inserts but she did not know if it was inner and outer coils of the essure insert.Essure ifu was followed, all broken pieces were retrieved.Broken pieces were removed.No was the answered when asked if essure was removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 22.4 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 01-dec-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 2.064 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: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-nov-2017: updated quality safety evaluation of ptc upon sample receipt.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 39-year-old female patient was involved in a reimbursement or compensation activity.The patient had essure (batch no.He011p5) inserted.The report describes a case of device breakage ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium") and complication of device insertion ("coils were pulled and remained attached to delivery catheter whereas insert remained in ostium").Other product or product use issues identified: device deployment issue "coils were pulled and remained attached to delivery catheter whereas insert remained in ostium" on (b)(6) 2017.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage and complication of device insertion.Essure treatment was not changed.At the time of the report, the device breakage was resolving and the complication of device insertion outcome was unknown.The relationship of complication of device insertion and device breakage to treatment with essure was not reported.The reporter commented: essure insertion was easily performed on right side with 5 trailing coils.On removal of delivery catheter on left side, numerous released coils were pulled and remained attached to delivery catheter whereas essure insert remained placed in ostium with 5 visible trailing coils.Insertion failure was not considered as essure insert remained placed.Bilateral insertion was performed.The pharmacist confirmed that they did not know if a breakage occurred but that it was possible.They had the impression that there were two inserts but she did not know if it was inner and outer coils of the essure insert.Essure ifu was followed, all broken pieces were retrieved.Broken pieces were removed.No was the answered when asked if essure was removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 22.4 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-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: 6689393
• MDR Text Key: 79745476
• Report Number: 2951250-2017-02429
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: ESS305
• Device Lot Number: HE011P5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 67