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

Model Number ESS305

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Sticking (1597); Separation Failure (2547)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 08/24/2016

Event Type  Injury  

Event Description

This is a spontaneous case report received from a gynecologist/obstetrician in (b)(6) on 25-aug-2016 which refers to a (b)(6) female patient who underwent an attempt to have essure (fallopian tube occlusion insert) inserted on (b)(6) 2016 (lot number he011au).Physician reported that placement attempt was performed under local anesthesia and implant stuck in uterine tubes and was impossible withdrawal of catheter from the implant.Removal of the implant under general anesthesia and the insertion was not performed.Physician reported that event was not linked to a cause from the patient.Company causality comment: this medically confirmed spontaneous case refers to a (b)(6) female patient who underwent an attempt to have essure (fallopian tube occlusion insert) inserted.However, implant stuck in uterine tubes and was impossible withdrawal of catheter from the implant.Removal of the implant was performed under general anesthesia.Device deployment issue is listed in the reference safety information for essure.In this particular case, the deployment issue occurred during the essure insertion procedure.Although this deployment could be a consequence of handling error, a causal relationship with essure inserts cannot be excluded.A product technical complaint analysis will be performed to evaluate if this deployment issue occurred due to a quality defect.This case was regarded as incident since device removal was required.Further information has been requested.

Manufacturer Narrative

Quality-safety evaluation of ptc received on 08-nov-2016: (b)(4).Batch number (b)(4), production date 20-oct-2015 and expiration date 28-oct-2018.(b)(4).Detachment difficulty is defined as a failure of the micro-insert to detach (separate) from the delivery system.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper detachment: rollback to initial hard stop.Depress button.Perform final rollback.Under normal circumstances, when the physician completes all deployment steps as outlined in the ifu, the micro-insert assembly will detach from the delivery wire and remain in the fallopian tube.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.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, inner catheter and delivery wire bonds were cured, damages were observed on delivery catheter (stretched), external fluids were observed on device.Due to device condition, inner catheter length cannot be measured.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 detachment difficulty event 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.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 is not applicable.Based on the provided information the defect type corresponds to the following meddra llt: device deployment issue.Company causality comment: this medically confirmed spontaneous case refers to a (b)(6) female patient who underwent an attempt to have essure (fallopian tube occlusion insert) inserted.However, implant stuck in uterine tubes and was impossible withdrawal of catheter from the implant.Removal of the implant was performed under general anesthesia.Device deployment issue is listed in the reference safety information for essure.In this particular case, the deployment issue occurred during the essure insertion procedure.Although this deployment could be a consequence of handling error, a causal relationship with essure inserts cannot be excluded.A review of the manufacturing batch record confirmed that the product met all release requirements.The sample was reviewed and the product quality defect could not be confirmed but is considered plausible.This case was regarded as incident since device removal was required.Further information has been requested.

Manufacturer Narrative

Quality-safety evaluation of ptc: ptc global number (b)(4).(b)(4).Lot number he011au (production date 20-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, inner catheter and delivery wire bonds were cured, damages were observed on delivery catheter (stretched), external fluids were observed on device.Due to device condition, inner catheter length cannot be measured.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 detachment difficulty event 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: device deployment issue and device shape alteration.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 29-dec-2016: no further information was obtained despite follow-up attempts.Company causality comment: this medically confirmed spontaneous case refers to a (b)(6) female patient who underwent an attempt to have essure (fallopian tube occlusion insert) inserted.However, implant stuck in uterine tubes and was impossible withdrawal of catheter from the implant.Removal of the implant was performed under general anesthesia.Device deployment issue is anticipated in the reference safety information for essure.In this particular case, the deployment issue occurred during the essure insertion procedure.Although this deployment could be a consequence of handling error, a causal relationship with essure inserts cannot be excluded.This case was regarded as incident because device removal was required.Based on the available information a product quality defect could not be confirmed but is considered plausible.Further information could not be obtained, despite follow-up attempts.

Manufacturer Narrative

Most recent follow-up information incorporated above includes: on 3-feb-2017: device breakage details were provided; surgical removal details were also provided.The event device breakage, pain and withdrawal of implant was impossible were added.Company causality comment: this medically confirmed spontaneous case refers to a (b)(6) female patient who underwent an attempt to have essure (fallopian tube occlusion insert) inserted.However, implant stuck in uterine tubes (seen as device deployment issue) and was impossible withdrawal of catheter from the implant.Essure catheter broke inside the tube at the time of retraction of the delivery catheter (device breakage).A laparoscopy withdrawal and ligation were performed, however withdrawal of implant was impossible.Device deployment issue and device breakage are anticipated in the reference safety information for essure.In this particular case, the deployment issue and device breakage occurred during the essure insertion procedure.This deployment could be a consequence of handling error.However, a causal relationship with essure inserts cannot be excluded.This case was regarded as incident because device removal was required.Based on the available information a product quality defect could not be confirmed but is considered plausible.An updated product technical further information could not be obtained, despite follow-up attempts.

Manufacturer Narrative

Quality-safety evaluation of ptc: (b)(4).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, inner catheter and delivery wire bonds were cured, damages were observed on delivery catheter(stretched), external fluids were observed on the device.Due to device condition, inner catheter length cannot be measured.Based on the follow-up received "essure catheter broke inside the tube at the time of retraction of the delivery catheter" the catheter was not broke.Lt was observed the tight pitch coil stretched.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 he011au (production date 20-oct-2015, expiration date 28-oct-2018) 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 event 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: device breakage, device deployment issue and device shape alteration.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the reported medical event is a known, possible, undesirable event and not indicative of a quality deficit per se.Most recent follow-up information incorporated above includes: on 24-mar-2017: quality-safety evaluation of ptc ((b)(4)).Company causality comment: this medically confirmed spontaneous case refers to a (b)(6) female patient who underwent an attempt to have essure (fallopian tube occlusion insert) inserted.However, implant stuck in uterine tubes (seen as device deployment issue) and was impossible withdrawal of catheter from the implant.Essure catheter broke inside the tube at the time of retraction of the delivery catheter (device breakage).A laparoscopy withdrawal and ligation were performed; however withdrawal of implant was impossible.Device deployment issue and device breakage are anticipated in the reference safety information for essure.In this particular case, the deployment issue and device breakage occurred during the essure insertion procedure.This deployment could be a consequence of handling error.However, a causal relationship with essure inserts cannot be excluded.This case was regarded as incident because device removal was required.The product was returned for a technical investigation, the catheter was not broken.Although we were unable to confirm this complaint, it is possible the essure device could have been defective prior to removal from the package; therefore a product quality defect could not be confirmed but is considered plausible.Further information could not be obtained, despite follow-up attempts.

Manufacturer Narrative

This spontaneous case was reported by a gynecologist and describes the occurrence of device breakage ("essure catheter broke inside the tube at the time of retraction of the delivery catheter") in a 47-year-old female patient who had essure (batch no.He011au) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "implant stuck in uterine tubes and impossible withdrawal of catheter from the implant (removal of the implant under general anesthesia)" (seriousness criteria medically significant and intervention required) on (b)(6) 2016 and device physical property issue "damages were observed on delivery catheter (stretched)".On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2016, 1 day after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device insertion ("insertion failure of the insert on the right side").On (b)(6) 2016, the patient experienced complication of device removal ("withdrawal of implant was impossible").On an unknown date, the patient experienced procedural pain ("pain").The patient was treated with surgery (laparoscopy withdrawal insert + ligation on (b)(6) 2016) and surgery (laparoscopy withdrawal insert + ligation on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, complication of device insertion, procedural pain and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device insertion, complication of device removal, device breakage and procedural pain with essure.The reporter commented: physician reported that placement attempt was performed under local anesthesia and implant stuck in uterine tubes and was impossible withdrawal of catheter from the implant.Introduction of catheter into uterine tube uneventful, withdrawal of catheter impossible (thumbwheel stuck) and it was noted that the catheter was broken and that a piece was still inside the tube.Withdrawal of implant was impossible.Removal of the implant under general anesthesia and the insertion was not performed.Physician reported that event was not linked to a cause from the patient.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-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 in 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: 5966165
• MDR Text Key: 55259722
• Report Number: 2951250-2016-01998
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• 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: HE011AU
• Other Device ID Number: (01)10888853003051(17)181028
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/19/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR