MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Catalog Number ESS305

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Difficult to Insert (1316); Uncoiled (1659)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of device breakage ("coil broke, hcp took coil out in three pieces"), device deployment issue ("essure would not roll back"), device difficult to use ("hcp tried to pull it out and the coil got caught on the hysteroscope, causing uncoiling") and complication of device insertion ("there was no placement") in a (b)(6) female patient who had essure (batch no.E01920) inserted for female sterilization.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, device deployment issue, device difficult to use and complication of device insertion.Essure was removed.At the time of the report, the device breakage and device deployment issue outcome was unknown and the device difficult to use and complication of device insertion had resolved.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue and device difficult to use with essure.The reporter commented: essure would not roll back.Hcp tried to pull it out and the coil got caught on the hysteroscope, causing uncoiling.Then hcp went in with graspers.Coil broke.Hcp took coil out in three pieces.Hcp will follow up with x-ray, in the future, to see if any coil is left in the patient.Company causality comment: this case report refers to a (b)(6) female patient who had an attempt to have essure inserted and, during insertion procedure, essure would not roll back; the coil broke and hcp took coil out in three pieces; hcp tried to pull it out and the coil got caught on the hysteroscope, causing uncoiling and there was no placement.All these events are anticipated in the reference safety information for essure.During difficult insertions and removals, single cases of essure breakage have been reported.In this particular case, the breakage occurred during the insertion procedure after a deployment issue, leading to a failed insertion.Considering the nature of these reported events, causality between the events and essure was considered as related.This case was regarded as other reportable incident, as although the device breakage did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Product technical analysis is being sought.Follow-up information from reporter is expected.

Manufacturer Narrative

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of device breakage ("coil broke, hcp took coil out in three pieces"), device deployment issue ("essure would not roll back"), device difficult to use ("hcp tried to pull it out and the coil got caught on the hysteroscope, causing uncoiling") and complication of device insertion ("there was no placement") in a (b)(6) year-old female patient who had essure (batch no.(b)(4)) inserted for female sterilization.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, device deployment issue, device difficult to use and complication of device insertion.Essure was removed.At the time of the report, the device breakage and device deployment issue outcome was unknown and the device difficult to use and complication of device insertion had resolved.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue and device difficult to use with essure.The reporter commented: essure would not roll back.Hcp tried to pull it out and the coil got caught on the hysteroscope, causing uncoiling.Then hcp went in with graspers.Coil broke.Hcp took coil out in three pieces.Hcp will follow up with x-ray, in the future, to see if any coil is left in the patient.Quality-safety evaluation of ptc: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The inserts outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.The quality unit 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 qu is unable to confirm any quality defect or device malfunction at this time.However, the qu cannot exclude the possibility of having a technical issue involved in the complaint.No capa investigation is required at this time because the possibility of a rollback difficulty and a micro-insert breaking 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.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 (b)(6) 2017: quality-safety evaluation of product technical complaint.Company causality comment: this case report refers to a (b)(6) year-old female patient who had an attempt to have essure inserted and, during insertion procedure, essure would not roll back; the coil broke and hcp took coil out in three pieces; hcp tried to pull it out and the coil got caught on the hysteroscope, causing uncoiling and there was no placement.All these events are anticipated in the reference safety information for essure.During difficult insertions and removals, single cases of essure breakage have been reported.In this particular case, the breakage occurred during the insertion procedure after a deployment issue, leading to a failed insertion.Considering the nature of these reported events, causality between the events and essure was considered as related.This case was regarded as other reportable incident, as although the device breakage 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.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.Follow-up information from reporter is expected.

Manufacturer Narrative

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of device breakage ("tip and middle of implant broke during placement/hcp attempted to remove remnant with operative hysteroscope but continued to break off small pieces"), device deployment issue ("essure would not roll back/device would not deploy"), device difficult to use ("hcp tried to pull it out and the coil got caught on the hysteroscope, causing uncoiling/hcp attempted removal but only partial removal achieved") and complication of device insertion ("there was no placement") in a (b)(6) female patient who had essure (batch no.E01920) inserted for female sterilization.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, device deployment issue, device difficult to use and complication of device insertion.At the time of the report, the device breakage, device deployment issue, device difficult to use and complication of device insertion had resolved.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue and device difficult to use with essure.The reporter commented: patient had no injury.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.9 kg/sqm.Most recent follow-up information incorporated above includes: on 16-jun-2017: device breakage with essure questionnaire received: event term amended and outcome updated.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 spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of device breakage ("coil broke, hcp took coil out in three pieces"), device deployment issue ("essure would not roll back"), device difficult to use ("hcp tried to pull it out and the coil got caught on the hysteroscope, causing uncoiling") and complication of device insertion ("there was no placement") in a (b)(6) female patient who had essure (batch no.E01920) inserted for female sterilization.On (b)(6) 2017, the patient had an attempt of essure insertion.On the same day, the patient experienced device breakage, device deployment issue, device difficult to use and complication of device insertion.Essure was removed.At the time of the report, the device breakage and device deployment issue outcome was unknown and the device difficult to use and complication of device insertion had resolved.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue and device difficult to use with essure.The reporter commented: essure would not roll back.Hcp tried to pull it out and the coil got caught on the hysteroscope, causing uncoiling.Then hcp went in with graspers.Coil broke.Hcp took coil out in three pieces.Hcp will follow up with x-ray, in the future, to see if any coil is left in the patient.Most recent follow-up information incorporated above includes: on 6-jun-2017: update of quality safety evaluation of product technical complaint.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.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6544649
• MDR Text Key: 74640143
• Report Number: 2951250-2017-01868
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: ESS305
• Device Lot Number: E01920
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 81