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

Model Number ESS205

Device Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Menstrual Irregularities (1959); Pain (1994); Swelling (2091); Cramp(s) (2193); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This is a spontaneous case report received from an attorney in the united states, on behalf of a plaintiff in united states on 29-mar-2016.It refers to the adult female consumer who had essure (ess205) (fallopian tube occlusion insert) in or around 2006 or 2007.The plaintiff had two children.Approximately three months after undergoing the essure procedure, an hysterosalpingogram (hsg) test was performed and plaintiff was advised that her coils were properly placed.However, plaintiffs post-procedure period had been marked by weight gain, prolonged menstrual cycles, and large blood clots during her menstrual cycle, painful menstrual cycle cramps, severe back and pelvic pain, and abdominal bloating.Plaintiff never experienced any of these conditions prior to undergoing the essure procedure.Shortly after undergoing the essure procedure, plaintiff began seeking treatment for her symptoms, including an obgyn as well as an endocrinologist, but physicians were unable to diagnose the cause.She had been diagnosed with various ailments, but no treatment has resolved her symptoms.In (b)(6) of 2014, plaintiff had an ultrasound which revealed that half of one of her essure coils was protruding out of her fallopian tube.In (b)(6) 2014, plaintiff underwent surgery to have one of her fallopian tubes and the essure coil removed.After the surgery, plaintiffs surgeon advised her that her coil was lying on her cervix.Plaintiff is prevented from practicing and enjoying the activities of daily life she enjoyed pre-operatively, and she has otherwise suffered serious and permanent injuries.Company causality comment: this case report was received from a lawyer on behalf of a female consumer/plaintiff who had essure (fallopian tube occlusion insert) inserted.More than 6 years later, she underwent an ultrasound which showed half of one of her essure coils was protruding out of her fallopian tube.She underwent a surgery to remove the coil.After this procedure, she was informed her coil was lying on her cervix.These events are listed according to the reference safety information for essure.During essure micro-insert therapy there is a risk that the device could move out of fallopian tube; this movement could be an expulsion (into the uterus or out of the body) or dislocation (into the fallopian tube or to peritoneal cavity).In this particular case, half of essure coil was found protruding out of the tube at ultrasound.One month later, the coil was found in cervix during a surgery.Considering the nature of these events, causality with essure cannot be excluded.Additionally, non-serious events were reported.This case was considered an incident, since device removal was required.A product technical analysis is being sought.Further information will be obtained through the litigation process.

Manufacturer Narrative

Follow-up received on 22-apr-2016 - quality-safety evaluation of ptc: ptc global number: (b)(4).For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.The reported medical events are not indicative of a quality deficit per se.Company causality comment: this case report was received from a lawyer on behalf of a female consumer/plaintiff who had essure (fallopian tube occlusion insert) inserted.More than 6 years later, she underwent an ultrasound which showed half of one of her essure coils was protruding out of her fallopian tube.She underwent a surgery to remove the coil.After this procedure, she was informed her coil was lying on her cervix.These events are listed according to the reference safety information for essure.During essure micro-insert therapy there is a risk that the device could move out of fallopian tube; this movement could be an expulsion (into the uterus or out of the body) or dislocation (into the fallopian tube or to peritoneal cavity).In this particular case, half of essure coil was found protruding out of the tube at ultrasound.One month later, the coil was found in cervix during a surgery.Considering the nature of these events, causality with essure cannot be excluded.Additionally, non-serious events were reported.This case was considered an incident, since device removal was required.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.Further information will be obtained through the litigation process.

Manufacturer Narrative

Data correction: the product code knh was replaced with hhs.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('half of one of her essure coils was protruding out of her fallopian tube') and device expulsion ('coil was laying on her cervix') in an adult female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 2.On an unknown date, the patient had essure (ess205) inserted.In 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), menorrhagia ("prolonged menstrual cycles with large blood clots"), dysmenorrhoea ("painful menstrual cycle cramps"), back pain ("severe back pain"), abdominal distension ("abdominal bloating") and pelvic pain ("severe pelvic pain") and was found to have weight increased ("weight gain").The patient was treated with surgery.Essure (ess205) was removed in (b)(6) 2014.At the time of the report, the device dislocation, device expulsion, menorrhagia, dysmenorrhoea, back pain, abdominal distension, pelvic pain and weight increased outcome was unknown.The reporter considered abdominal distension, back pain, device dislocation, device expulsion, dysmenorrhoea, menorrhagia, pelvic pain and weight increased to be related to essure (ess205).Quality-safety evaluation of ptc: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.The reported medical events are not indicative of a quality deficit per se.Most recent follow-up information incorporated above includes: on 19-nov-2019: this case is processed as a retention case of the deletion case number (b)(4).All source document information, reporter and reference section from deletion case (b)(4) is added to this case.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this 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, CA 13353 ; GM 13353
• MDR Report Key: 5605389
• MDR Text Key: 43543692
• Report Number: 2951250-2016-00401
• 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,Followup,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR