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); Difficult to Remove (1528); Sticking (1597); Mechanical Jam (2983)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of device breakage ("coil broke close to the tubal opening"), complication of device insertion ("coil broke close to the tubal opening"), device deployment issue ("thumbweel used to retract the remainder of the device but the thumbweel was stuck, numerous attempts were made to "unjam" the thumbweel") and complication of device removal ("hysteroscopic grasper pulled gently on the straightened coil.Further attempts to remove the coil were abandoned") in a (b)(6) female patient who had essure (batch no.E24119) inserted for female sterilization.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage, complication of device insertion, device deployment issue and complication of device removal.At the time of the report, the device breakage, complication of device insertion, device deployment issue 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 device deployment issue with essure.Diagnostic results: gynecological examination for essure insertion: upon addressing the right ostium the device slipped into the opening easily and the thumbwheel worked well.After positioning the golden band just outside the ostium and pushing the button on the device an attempt to use the thumbweel to retract the remainder of the device but the thumbweel was stuck.Numerous attempts were made to "unjam" the thumbweel, pushing the button and gently moving the device back and forth, all without success.It did seem that the devices could be backed out of the tube but after removing it the stretched out coil was noted to protrude into the uterine cavity.The device was completely removed from the uterus and a hysteroscopic grasper was introduced and used to pull gently on the straightened coil.The coil broke close to the tubal opening and further attempts to remove the coil were abandoned.It was decided to terminate the procedure at this point and follow up with an hsg at 3 months as there is a chance that the amount of coil remaining within the tube could bring about occlusion.Company causality comment: a (b)(6) female patient had essure (fallopian tube occlusion insert) inserted and it was reported that the coil broke close to the tubal opening.Device breakage is regarded as anticipated according to the reference safety information for essure.It was reported that after positioning the golden band just outside the ostium and pushing the button on the device an attempt to use the thumbweel to retract the remainder of the device but the thumbweel was stuck (seen as device deployment issue).Hysteroscopic grasper pulled gently on the straightened coil.Further attempts to remove the coil were abandoned.As the device breakage occurred at the time of essure insertion procedure, a causal relationship with essure cannot be excluded.Although there was no reported death or serious health deterioration, this might have occurred under less fortunate circumstances and therefore case was regarded as a reportable incident.Further information and product technical analysis are being sought.

Manufacturer Narrative

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of device breakage ("coil broke close to the tubal opening, in ostium (device inner coil broke in the green release catheter)"), complication of device insertion ("coil broke close to the tubal opening"), device deployment issue ("thumbweel used to retract the remainder of the device but the thumbweel was stuck, numerous attempts were made to "unjam" the thumbweel") and complication of device removal ("hysteroscopic grasper pulled gently on the straightened coil.Further attempts to remove the coil were abandoned") in a (b)(6) female patient who had essure (batch no.E24119) inserted for female sterilization.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, complication of device insertion, device deployment issue and complication of device removal.At the time of the report, the device breakage had resolved and the complication of device insertion, device deployment issue 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 device deployment issue with essure.The reporter commented: the device inner coil broke (deployment issue) in the green release catheter, however the instructions in the ifu were followed.No deviation from the insertion procedure occurred.The essure was not removed, and it was not medically necessary to removed essure.The broken pieces were retrieved from uterus and there was no injury with patient reported.But the breakage could led to serious injury under less fortunate circumstances.Patient recovered.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).X-ray - on an unknown date: device breakage diagnosed.Gynecological examination for essure insertion: upon addressing the right ostium the device slipped into the opening easily and the thumbwheel worked well.After positioning the golden band just outside the ostium and pushing the button on the device an attempt to use the thumbweel to retract the remainder of the device but the thumbweel was stuck.Numerous attempts were made to "unjam" the thumbweel, pushing the button and gently moving the device back and forth, all without success.It did seem that the devices could be backed out of the tube but after removing it the stretched out coil was noted to protrude into the uterine cavity.The device was completely removed from the uterus and a hysteroscopic grasper was introduced and used to pull gently on the straightened coil.The coil broke close to the tubal opening and further attempts to remove the coil were abandoned.It was decided to terminate the procedure at this point and follow up with an hsg at 3 months as there is a chance that the amount of coil remaining within the tube could bring about occlusion.Quality-safety evaluation of ptc: lot number: e24119 - manufacturing date 29-jul-2015 - expiration date: 28-jul-2018.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 9-may-2017: quality-safety evaluation of product technical complaint (device evaluation received) on 22-may-2017: device breakage with essure questionnaire was received: device breakage information updated.Company causality comment: a (b)(6) female patient had essure (fallopian tube occlusion insert) inserted and it was reported that the coil broke close to the tubal opening, in ostium (device inner coil broke in the green release catheter).Device breakage is regarded as anticipated according to the reference safety information for essure.It was reported that after positioning the golden band just outside the ostium and pushing the button on the device an attempt to use the thumbweel to retract the remainder of the device but the thumbweel was stuck (seen as device deployment issue).Hysteroscopic grasper pulled gently on the straightened coil.Further attempts to remove the coil were abandoned.Essure was not removed, since it was not medically necessary.As the device breakage occurred at the time of essure insertion procedure, a causal relationship with essure cannot be excluded.Although there was no reported death or serious health deterioration, this might have occurred under less fortunate circumstances and therefore case was regarded as a reportable incident.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.

Manufacturer Narrative

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of device breakage ("coil broke close to the tubal opening, in ostium (device inner coil broke in the green release catheter)"), complication of device insertion ("coil broke close to the tubal opening"), device deployment issue ("thumbwheel used to retract the remainder of the device but the thumbwheel was stuck, numerous attempts were made to "unjam" the thumbwheel") and complication of device removal ("hysteroscopic grasper pulled gently on the straightened coil.Further attempts to remove the coil were abandoned") in a (b)(6) year old female patient who had essure (batch no.E24119) inserted for female sterilization.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, complication of device insertion, device deployment issue and complication of device removal.At the time of the report, the device breakage and complication of device removal had resolved and the complication of device insertion and device deployment issue outcome was unknown.The reporter provided no causality assessment for complication of device insertion, complication of device removal, device breakage and device deployment issue with essure.The reporter commented: the device inner coil broke (deployment issue) in the green release catheter, however the instructions in the ifu were followed.No deviation from the insertion procedure occurred.The essure was not removed, and it was not medically necessary to removed essure.The broken pieces were retrieved from uterus and there was no injury with patient reported.But the breakage could led to serious injury under less fortunate circumstances.Patient recovered.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.2 kg/sqm.X-ray on an unknown date: device breakage diagnosed.Gynecological examination for essure insertion: upon addressing the right ostium the device slipped into the opening easily and the thumbwheel worked well.After positioning the golden band just outside the ostium and pushing the button on the device an attempt to use the thumbwheel to retract the remainder of the device but the thumbwheel was stuck.Numerous attempts were made to "unjam" the thumbwheel, pushing the button and gently moving the device back and forth, all without success.It did seem that the devices could be backed out of the tube but after removing it the stretched out coil was noted to protrude into the uterine cavity.The device was completely removed from the uterus and a hysteroscopic grasper was introduced and used to pull gently on the straightened coil.The coil broke close to the tubal opening and further attempts to remove the coil were abandoned.It was decided to terminate the procedure at this point and follow up with an hsg at 3 months as there is a chance that the amount of coil remaining within the tube could bring about occlusion.Most recent follow-up information incorporated above includes: on 11-jul-2017: update of quality safety evaluation of product technical complaint.Other reportable 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: 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: 6525321
• MDR Text Key: 74151235
• Report Number: 2951250-2017-01680
• 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
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: ESS305
• Device Lot Number: E24119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• 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: 24 YR