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

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Menstrual Irregularities (1959); Pain (1994); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of pelvic pain ("pelvic pain") and device breakage ("hcp did not remove all the pieces") in a (b)(6) female patient who had essure (lot# c22909) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In 2015, the patient had essure inserted.On the same day, the patient experienced device difficult to use ("hcp placed essure bilaterally, it was a tricky procedure but successful").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), menorrhagia ("abnormal uterine bleeding like heavier periods") and weight increased ("weight gain").The patient was treated with surgery (hcp attempted to remove essure on patient's request, not all pieces removed).In 2016, the patient experienced complication of device removal ("hcp did not remove all the pieces").Essure treatment was not changed.At the time of the report, the pelvic pain, device breakage, complication of device removal, device difficult to use, menorrhagia and weight increased outcome was unknown.The reporter provided no causality assessment for complication of device removal, device breakage, device difficult to use, menorrhagia, pelvic pain and weight increased with essure.The reporter commented: at the first year follow-up, the patient said everything was fine, no symptoms and everything was just perfect.At 2 and a half years post-procedure, the patient came back and claimed she wanted the essure out because of symptoms that were synonymous with what was online.The hcp took the patient back in and attempted to remove them.The removal did not remove all the pieces.At year 3, the patient has come back and is complaining about the same symptoms and wants the hcp or hospital to remove her remaining pieces and she doesn't want to pay for it.She is requesting for the radiology report and other notes.Hcp is worried that she wants all of this for litigation purposes.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: good.Company causality comment: this medically confirmed spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted.She presented pelvic pain.Essure had to be removed and during removal hcp did not remove all the pieces (seen as device breakage).Device breakage and pelvic pain are anticipated in essure reference safety information.Considering that breakage occurred in association with essure removal procedure, a causal relationship with essure insert cannot be excluded.Regarding pelvic pain the causal relationship cannot be excluded since pelvic pain may occur after essure's insertion.This case is regarded as incident, since a procedure was required to remove essure.Further information and product technical analysis is awaited.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of pelvic pain ("pelvic pain") and device breakage ("hcp did not remove all the pieces") in a (b)(6) female patient who had essure (lot# c22909) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In 2015, the patient had essure inserted.On the same day, the patient experienced device difficult to use ("hcp placed essure bilaterally, it was a tricky procedure but successful").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), menorrhagia ("abnormal uterine bleeding like heavier periods") and weight increased ("weight gain").The patient was treated with surgery (hcp attempted to remove essure on patient's request, not all pieces removed).In 2016, the patient experienced complication of device removal ("hcp did not remove all the pieces").Essure treatment was not changed.At the time of the report, the pelvic pain, device breakage, complication of device removal, device difficult to use, menorrhagia and weight increased outcome was unknown.The reporter provided no causality assessment for complication of device removal, device breakage, device difficult to use, menorrhagia, pelvic pain and weight increased with essure.The reporter commented: at the first year follow-up, the patient said everything was fine, no symptoms and everything was just perfect.At 2 and a half years post-procedure, the patient came back and claimed she wanted the essure out because of symptoms that were synonymous with what was online.The hcp took the patient back in and attempted to remove them.The removal did not remove all the pieces.At year 3, the patient has come back and is complaining about the same symptoms and wants the hcp or hospital to remove her remaining pieces and she doesn't want to pay for it.She is requesting for the radiology report and other notes.Hcp is worried that she wants all of this for litigation purposes.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: good quality-safety evaluation of ptc: lot number: c22909 (manufacturing date: 07-feb-2014 and expiration date: 28-feb-2017).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.Based on the technical assessment, lot number was provided therefore, 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 quality unit was unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because the possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 11-may-2017: quality-safety evaluation of ptc.Company causality comment: this medically confirmed spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted.She presented pelvic pain.Essure had to be removed and during removal hcp did not remove all the pieces (seen as device breakage).Device breakage and pelvic pain are anticipated in essure reference safety information.Considering that breakage occurred in association with essure removal procedure, a causal relationship with essure insert cannot be excluded.Regarding pelvic pain the causal relationship cannot be excluded since pelvic pain may occur after essure's insertion.This case is regarded as incident, since a procedure was required to remove essure.The product technical analysis concluded, the outcome of the investigation resulted in an unconfirmed quality defect.Further information is awaited.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of pelvic pain ("pelvic pain") and device breakage ("hcp did not remove all the pieces") in a (b)(6) year-old female patient who had essure (batch no.C22909) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "hcp placed essure bilaterally, it was a tricky procedure but successful" in 2015.In 2015, the patient had essure inserted.In 2016, the patient experienced complication of device removal ("hcp did not remove all the pieces").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), menorrhagia ("abnormal uterine bleeding like heavier periods") and weight increased ("weight gain").The patient was treated with surgery (hcp attempted to remove essure on patient's request, not all pieces removed).Essure treatment was not changed.At the time of the report, the pelvic pain, device breakage, complication of device removal, menorrhagia and weight increased outcome was unknown.The reporter provided no causality assessment for complication of device removal, device breakage, menorrhagia, pelvic pain and weight increased with essure.The reporter commented: at the first year follow-up, the patient said everything was fine, no symptoms and everything was just perfect.At 2 and a half years post-procedure, the patient came back and claimed she wanted the essure out because of symptoms that were synonymous with what was online.The hcp took the patient back in and attempted to remove them.The removal did not remove all the pieces.At year 3, the patient has come back and is complaining about the same symptoms and wants the hcp or hospital to remove her remaining pieces and she doesn't want to pay for it.She is requesting for the radiology report and other notes.Hcp is worried that she wants all of this for litigation purposes.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: good.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.Based on the technical assessment, lot number was provided therefore, 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 quality unit was unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because the possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 29-aug-2017: reporter did not respond to final f/u attempt consider follow-up closed.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
• 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: 6561706
• MDR Text Key: 74987395
• Report Number: 2951250-2017-01903
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: ESS305
• Device Lot Number: C22909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 05/11/2017
• Supplement Dates Manufacturer Received: Not provided; 08/29/2017
• Supplement Dates FDA Received: 05/11/2017; 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2014
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 34 YR