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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fatigue (1849); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Abnormal Vaginal Discharge (2123); Anxiety (2328); Depression (2361); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of endometritis ('chronic endometritis') in an adult female patient who had essure (batch no.841530) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "novasure endometrial ablation on (b)(6) 2011".The patient's medical history included chest pain, mitral valve disease, shortness of breath, augmentation mammoplasty, appendectomy, dysfunctional uterine bleeding, itching and heart racing.Previously administered products included for an unreported indication: atomoxetine in 2006.Concurrent conditions included body mass index normal, congestive heart failure, vaginal odor, back muscle spasms, burning sensation, menses irregular, menstrual cramp, suicidal ideation, dysuria, skin rough, constipation, vitamin d decreased and oedema peripheral.Concomitant products included buspirone since (b)(6) 2014 for anxiety as well as bupropion since (b)(6) 2010, citalopram since (b)(6) 2011, eszopiclone since 2006, fluoxetine from (b)(6) 2016 to (b)(6) 2017, furosemide since 2006, hydroxyzine from (b)(6) 2016 to (b)(6) 2017, nsaids since (b)(6) 2011, paracetamol (acetaminophen) since (b)(6) 2011, potassium chloride (klor con) since (b)(6) 2011 and zaleplon from (b)(6) 2012 to (b)(6) 2012.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain ("physical pain / pain"), mood swings ("hormonal changes describe: mood swing"), vaginal infection ("infection (bladder/urinary tract/vaginal) type: vaginal"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), fatigue ("fatigue") and vaginal discharge ("vaginal discharge") and was found to have weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2011, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").On an unknown date, the patient experienced endometritis (seriousness criteria medically significant and intervention required).The patient was treated with endometrial curettings, dilation and curettage.Essure treatment was not changed.At the time of the report, the endometritis, mood swings, vaginal haemorrhage, menorrhagia, vaginal infection, depression, anxiety, fatigue, vaginal discharge and weight increased outcome was unknown and the pelvic pain was resolving.The reporter considered anxiety, depression, endometritis, fatigue, menorrhagia, mood swings, pelvic pain, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.The reporter commented: current weight (b)(6) lbs.Discrepancy to be noted in essure removal: outcome of event pelvic pain was recovering one month after removal date as reported.Discrepancy noted: previous version reported as "hsg performed with result" while in this version its reported as "plaintiff did not undergo an essure confirmation test".Novasure endometrial ablation device at a depth of 5 cm and the width was found to be 4.8 cm.Novasure endometrial ablation was carried out for 2 minutes 2 seconds at power wattage of 132 watts.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.8 kg/sqm.Hysterosalpingogram - on an unknown date: essure device was successfully occluded.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: vaginal discharge, weight gain, mood swings, anxiety, depression.Concerning the injuries reported in this case, the following ones were reported via medical records: endometritis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-jun-2019: pfs and mr received: lot number was added.Events: mood swing, abnormal bleeding (vaginal, menorrhagia), vaginal infection, depression, mental anguish, fatigue, pain, vaginal discharge, weight gain, device monitoring error were added.Medical history and historical drugs were added.Event onset date and outcome were added.Concomitant drugs and conditions were added.Reporter causality comments were added.Reporters were added.Plaintiffs demographics were added.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of endometritis ('chronic endometritis') in an adult female patient who had essure (batch no.841530) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "novasure endometrial ablation on (b)(6) 2011".The patient's medical history included chest pain, mitral valve disease, shortness of breath, augmentation mammoplasty, appendectomy, dysfunctional uterine bleeding, itching and heart racing.Previously administered products included for an unreported indication: atomoxetine in 2006.Concurrent conditions included body mass index normal, congestive heart failure, vaginal odor, back muscle spasms, burning sensation, menses irregular, menstrual cramps, suicidal ideation, dysuria, skin rough, constipation, vitamin d decreased and oedema peripheral.Concomitant products included buspirone since (b)(6) 2014 for anxiety as well as bupropion since (b)(6) 2010, citalopram since (b)(6) 2011, eszopiclone since 2006, fluoxetine from (b)(6) 2016 to (b)(6) 2017, furosemide since 2006, hydroxyzine from (b)(6) 2016 to (b)(6) 2017, nsaids since (b)(6) 2011, paracetamol (acetaminophen) since (b)(6) 2011, potassium chloride (klor con) since (b)(6) 2011 and zaleplon from (b)(6) 2012 to (b)(6) 2012.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain ("physical pain / pain"), mood swings ("hormonal changes describe: mood swing"), vaginal infection ("infection (bladder/urinary tract/vaginal) type: vaginal"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), fatigue ("fatigue") and vaginal discharge ("vaginal discharge") and was found to have weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2011, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").On an unknown date, the patient experienced endometritis (seriousness criteria medically significant and intervention required).The patient was treated with endometrial curretings, dilation and currettage.Essure treatment was not changed.At the time of the report, the endometritis, mood swings, vaginal haemorrhage, menorrhagia, vaginal infection, depression, anxiety, fatigue, vaginal discharge and weight increased outcome was unknown and the pelvic pain was resolving.The reporter considered anxiety, depression, endometritis, fatigue, menorrhagia, mood swings, pelvic pain, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.The reporter commented: current weight 189 lbs.Discrepancy to be noted in essure removal: outcome of event pelvic pain was recovering one month after removal date as reported.Discrepancy noted : previous version reported as "hsg performed with result" while in this version its reported as "plaintiff did not undergo an essure confirmation test".Novasure endometrial ablation device at a depth of 5 cm and the width was found to be 4.8 cm.Novasure endometrial ablation was carried out for 2 minutes 2 seconds at power wattage of 132 watts.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.8 kg/sqm.Hysterosalpingogram - on an unknown date: essure device was successfully occluded.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: vaginal discharge, weight gain, mood swings, anxiety, depression.Concerning the injuries reported in this case, the following ones were reported via medical records: endometritis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-jun-2019: quality safety evaluation of product technical complaint.Incident': we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, 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, 13353 ; GM 13353
• MDR Report Key: 8721226
• MDR Text Key: 148746134
• Report Number: 2951250-2019-02992
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 06/25/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2014
• Device Model Number: ESS305
• Device Lot Number: 841530
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ACETAMINOPHEN; BUPROPION; BUPROPION; BUSPIRONE; BUSPIRONE; CITALOPRAM; CITALOPRAM; ESZOPICLONE; ESZOPICLONE; FLUOXETINE; FLUOXETINE; FUROSEMIDE; FUROSEMIDE; HYDROXYZINE; HYDROXYZINE; KLOR CON; KLOR CON; NSAIDS; NSAIDS; ZALEPLON; ZALEPLON; ACETAMINOPHEN; BUPROPION; BUSPIRONE; CITALOPRAM; ESZOPICLONE; FLUOXETINE; FUROSEMIDE; HYDROXYZINE; KLOR CON; NSAIDS; ZALEPLON
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 64