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

Model Number ESS305

Device Problems Break (1069); Misfire (2532); Expulsion (2933); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hemorrhage/Bleeding (1888); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of genital haemorrhage ("bled constantly") and uterine haemorrhage ("abnormal uterine bleeding") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Medical conditions: before essure she did not have problems with bleeding or periods or pelvic/ back pain.On (b)(6) 2015, the patient had essure inserted.On the same day, the patient experienced device breakage ("implant - breakage - fiber"), device deployment issue ("right essure coil misfired because the inner filament was extracted with the deployment device") and device difficult to use ("difficulty visualizing the right ostia").On (b)(6) 2015, the patient experienced uterine haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("abdominal pain, right lower quadrant pain"), fatigue ("fatigue"), device expulsion ("probably one of the coils floating in her uterus"), economic problem ("unable to afford the hsg procedure"), pelvic pain ("sharp pains in her pelvic area") and back pain ("bad lower back pain").At the time of the report, the device breakage, genital haemorrhage, uterine haemorrhage, device deployment issue, device difficult to use, abdominal pain lower, fatigue, device expulsion, economic problem, pelvic pain and back pain outcome was unknown.The reporter provided no causality assessment for device breakage with essure.The reporter considered abdominal pain lower, back pain, device deployment issue, device difficult to use, device expulsion, economic problem, fatigue, genital haemorrhage, pelvic pain and uterine haemorrhage to be related to essure.The reporter commented: she was given a three-month prescription for birth control to help with the bleeding.She is seriously considering a hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on (b)(6) 2015: 1.4 cm echogenic area was found in uterus; on an unknown date: unable to see one side of coil in fallopian tube.Quality-safety evaluation of ptc: deployment difficulty is defined as a failure of the micro-insert outer coils to expand from the wound down position.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper deployment: 1) rollback to initial hard stop.2) depress button.3) perform final rollback.Several factors can contribute to a deployment 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 expanding and 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 we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility of a deployment difficulty and a fiber breaking event are anticipated event and there was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 28-apr-2017: quality-safety evaluation of product technical complaint received: event "implant - breakage - fiber" added.Company causality comment: this spontaneous legal case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and she bled constantly (seen as genital hemorrhage) and had abnormal uterine bleeding (seen as uterine hemorrhage).Uterine and genital bleeding may have multiple etiologies.No alternative explanation was provided in the present case.According to the consumer, during the insertion procedure the right essure coil misfired because the inner filament was extracted with the deployment device.Also, there was difficulty visualizing the right ostia.Upon receipt of the product technical analysis, event implant - breakage - fiber was added, and the case was upgraded to other reportable incident, as although there was no reported death or serious health deterioration, this might have occurred under less fortunate circumstances.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Further information will be obtained through the litigation process.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('implant - breakage - fiber') in a 38-year-old female patient who had essure 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 "difficulty visualizing the right ostia" on (b)(6) 2015 and device deployment issue "right essure coil misfired because the inner filament was extracted with the deployment device" on (b)(6)2015.Medical conditions: before essure she did not have problems with bleeding or periods or pelvic/ back pain.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced device breakage (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced abnormal uterine bleeding ("abnormal uterine bleeding").On an unknown date, the patient experienced genital haemorrhage ("bled constantly"), abdominal pain lower ("abdominal pain, right lower quadrant pain"), fatigue ("fatigue"), device expulsion ("probably one of the coils floating in her uterus"), economic problem ("unable to afford the hsg procedure"), pelvic pain ("sharp pains in her pelvic area") and back pain ("bad lower back pain").At the time of the report, the device breakage, genital haemorrhage, abnormal uterine bleeding, abdominal pain lower, fatigue, device expulsion, economic problem, pelvic pain and back pain outcome was unknown.The reporter provided no causality assessment for device breakage with essure.The reporter considered abdominal pain lower, abnormal uterine bleeding, back pain, device expulsion, economic problem, fatigue, genital haemorrhage and pelvic pain to be related to essure.The reporter commented: she was given a three-month prescription for birth control to help with the bleeding.She is seriously considering a hysterectomy.No.Of coils: the coils were, however, were left in place and there was good placement as far as only about five coils being left on the exterior.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on an unknown date: results: unable to see one side of coil in fallopian tube; on (b)(6) 2015: results: 1.4 cm echogenic area was found in uterus.Quality-safety evaluation of ptc: deployment difficulty is defined as a failure of the micro-insert outer coils to expand from the wound down position.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper deployment: 1) rollback to initial hard stop 2) depress button 3) perform final rollback.Several factors can contribute to a deployment 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 expanding and 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 we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility of a deployment difficulty and a fiber breaking event are anticipated event and there was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 15-jun-2021: mr received : reporter information added and rcc was updated.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary 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: 6568571
• MDR Text Key: 75426953
• Report Number: 2951250-2017-01955
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR