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 Anemia (1706); Arthritis (1723); Hair Loss (1877); Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Urinary Tract Infection (2120); Depression (2361); Weight Changes (2607)

Event Date 02/01/2011

Event Type  Injury  

Event Description

"ntaneous" case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pelvic pain"), rheumatoid arthritis ("rheumatoid arthritis") and aplastic anaemia ("aplastic anemia") in a (b)(6) female patient who had essure (batch no.787008) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo confirmation test".The patient's past medical history included obesity, anxiety, nocturnal awakening, crying, depressed mood, fatigue, insomnia, irritability, mood altered, restlessness, feelings of worthlessness, hallucinations, chest pain, dysmenorrhea and menorrhagia.Previously administered products included for an unreported indication: mirena from 2006 to 2011 and depo provera on (b)(6) 2011.Concurrent conditions included stress urinary incontinence, cramp in lower abdomen, foot sprain, low back pain, frequency urinary, dyspareunia, nausea, abdominal pain, sensation of heaviness, vaginal pain, urinary urgency, constipation, foreign body in reproductive tract, cyst removal, cystoscopy, uterine bleeding, biopsy endometrium, leg cramps and anhedonia.Concomitant products included iron (iron supplement) for aplastic anemia, amlodipine since 2017 and metoprolol since 2017 for blood pressure high, omeprazole since 2016 for heartburn, eletriptan hydrobromide (relpax) since 2012 for migraine and headache as well as ibuprofen.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In 2011, the patient experienced migraine ("worsening of migraines"), headache ("worsening of headaches"), urinary tract infection ("recurring utis "), vulvovaginal mycotic infection ("yeast infections") and hormone level abnormal ("hormonal changes").In 2012, the patient experienced alopecia ("hair loss") and weight decreased ("weight loss").In 2014, the patient experienced rheumatoid arthritis (seriousness criterion medically significant) and tooth disorder ("dental problems").In 2015, the patient experienced depression ("depression").In 2016, the patient experienced hypertension ("high blood pressure").In 2017, the patient experienced aplastic anaemia (seriousness criterion medically significant) and raynaud's phenomenon ("raynaud's disease").The patient was treated with surgery (a left sided tubal ligation with kleppinger, right salpingectomy, and diagnostic laparoscopy.).Essure was removed on (b)(6) 2011.At the time of the report, the pelvic pain, rheumatoid arthritis, aplastic anaemia, alopecia, weight decreased, tooth disorder, hypertension, migraine, headache, raynaud's phenomenon, urinary tract infection, vulvovaginal mycotic infection, hormone level abnormal and depression outcome was unknown.The reporter considered alopecia, aplastic anaemia, depression, headache, hormone level abnormal, hypertension, migraine, pelvic pain, raynaud's phenomenon, rheumatoid arthritis, tooth disorder, urinary tract infection, vulvovaginal mycotic infection and weight decreased to be related to essure.The reporter commented: coil appears to be in the tube and not in the uterus.The patient counseled on only 1 essure device being placed and on the inflamed appearance of the uterine activity at time of hs that prevented the placing a 2nd essure.Pt understands and still wishes to have permanent sterilization.5 mm laparoscope placed through umbilicus using direct view technique.Two accessory 5 mm ports were placed one on right side and one on left side.Diagnostic results (normal ranges are provided in parenthesis if available): (b)(6).On (b)(6) 2011 sono performed by dr (b)(6) at time of this visit and coil appears to be in the lube and not in the uterus.Concerning the injuries reported in this case, the following one/ones were confirm in patient¿s medical records: pelvic pain, urinary tract infection, migraine, alopecia, depression.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 4-sep-2018: plaintiff fact sheet and medical records received.Events added from pfs- hormonal changes, recurring utis and yeast infections, rheumatoid arthritis, aplastic anemia, raynaud's disease, worsening of migraines/ headaches, high blood pressure, dental problems, weight loss, hair loss, severe and persistent pelvic pain, depression, did not undergo confirmation test.Concomitant disease, lot number, historical condition, historical drug, concomitant drug were added.Plaintiff¿s name were update.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.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pelvic pain"), rheumatoid arthritis ("rheumatoid arthritis") and aplastic anaemia ("aplastic anemia") in a 35-year-old female patient who had essure (batch no.787008) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo confirmation test".The patient's past medical history included obesity, anxiety, nocturnal awakening, crying, depressed mood, fatigue, insomnia, irritability, mood altered, restlessness, feelings of worthlessness, hallucinations, chest pain, dysmenorrhea and menorrhagia.Previously administered products included for an unreported indication: mirena from 2006 to 2011 and depo provera on 10-jan-2011.Concurrent conditions included stress urinary incontinence, cramp in lower abdomen, foot sprain, low back pain, frequency urinary, dyspareunia, nausea, abdominal pain, sensation of heaviness, vaginal pain, urinary urgency, constipation, foreign body in reproductive tract, cyst removal, cystoscopy, uterine bleeding, biopsy endometrium, leg cramps and anhedonia.Concomitant products included iron (iron supplement) for aplastic anemia, amlodipine since 2017 and metoprolol since 2017 for blood pressure high, omeprazole since 2016 for heartburn, eletriptan hydrobromide (relpax) since 2012 for migraine and headache as well as ibuprofen.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In 2011, the patient experienced migraine ("worsening of migraines"), headache ("worsening of headaches"), urinary tract infection ("recurring utis "), vulvovaginal mycotic infection ("yeast infections") and hormone level abnormal ("hormonal changes").In 2012, the patient experienced alopecia ("hair loss") and weight decreased ("weight loss").In 2014, the patient experienced rheumatoid arthritis (seriousness criterion medically significant) and tooth disorder ("dental problems").In 2015, the patient experienced depression ("depression").In 2016, the patient experienced hypertension ("high blood pressure").In 2017, the patient experienced aplastic anaemia (seriousness criterion medically significant) and raynaud's phenomenon ("raynaud's disease").The patient was treated with surgery (a left sided tubal ligation with kleppinger, right salpingectomy, and diagnostic laparoscopy.).Essure was removed on 17-feb-2011.At the time of the report, the pelvic pain, rheumatoid arthritis, aplastic anaemia, alopecia, weight decreased, tooth disorder, hypertension, migraine, headache, raynaud's phenomenon, urinary tract infection, vulvovaginal mycotic infection, hormone level abnormal and depression outcome was unknown.The reporter considered alopecia, aplastic anaemia, depression, headache, hormone level abnormal, hypertension, migraine, pelvic pain, raynaud's phenomenon, rheumatoid arthritis, tooth disorder, urinary tract infection, vulvovaginal mycotic infection and weight decreased to be related to essure.The reporter commented: coil appears to be in the tube and not in the uterus.The patient counseled on only 1 essure device being placed and on the inflamed appearance of the uterine activity at time of hs that prevented the placing a 2nd essure.Pt understands and still wishes to have permanent sterilization.5mm laparoscope placed through umbilicus using direct view technique.Two accessory 5mm ports were placed one on right side and one on left side.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 86.18 kgs.On 16-feb-2011 sono performed by dr vincent at time of this visit and coil appears to be in the lube and not in the uterus.Concerning the injuries reported in this case, the following one/ones were confirm in patient¿s medical records: pelvic pain, urinary tract infection, migraine, alopecia, depression.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 14-sep-2018: quality safety evaluation of ptc.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.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pelvic pain"), rheumatoid arthritis ("rheumatoid arthritis") and aplastic anaemia ("aplastic anemia") in a 35-year-old female patient who had essure (batch no.787008) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo confirmation test".The patient's past medical history included obesity, anxiety, nocturnal awakening, crying, depressed mood, fatigue, insomnia, irritability, mood altered, restlessness, feelings of worthlessness, hallucinations, chest pain, dysmenorrhea and menorrhagia.Previously administered products included for an unreported indication: mirena from 2006 to 2011 and depo provera on (b)(6) 2011.Concurrent conditions included stress urinary incontinence, cramp in lower abdomen, foot sprain, low back pain, frequency urinary, dyspareunia, nausea, abdominal pain, sensation of heaviness, vaginal pain, urinary urgency, constipation, foreign body in reproductive tract, cyst removal, cystoscopy, uterine bleeding, biopsy endometrium, leg cramps, anhedonia and obesity.Concomitant products included iron (iron supplement) for aplastic anemia, amlodipine since 2017 and metoprolol since 2017 for blood pressure high, omeprazole since 2016 for heartburn, eletriptan hydrobromide (relpax) since 2012 for migraine and headache as well as ibuprofen.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In 2011, the patient experienced migraine ("worsening of migraines"), headache ("worsening of headaches"), urinary tract infection ("recurring utis"), vulvovaginal mycotic infection ("yeast infections") and hormone level abnormal ("hormonal changes").In 2012, the patient experienced alopecia ("hair loss") and weight decreased ("weight loss").In 2014, the patient experienced rheumatoid arthritis (seriousness criterion medically significant) and tooth disorder ("dental problems").In 2015, the patient experienced depression ("depression").In 2016, the patient experienced hypertension ("high blood pressure").In 2017, the patient experienced aplastic anaemia (seriousness criterion medically significant) and raynaud's phenomenon ("raynaud's disease").The patient was treated with surgery (a left sided tubal ligation with kleppinger, right salpingectomy, and diagnostic laparoscopy.).Essure was removed on (b)(6) 2011.At the time of the report, the pelvic pain, rheumatoid arthritis, aplastic anaemia, alopecia, weight decreased, tooth disorder, hypertension, migraine, headache, raynaud's phenomenon, urinary tract infection, vulvovaginal mycotic infection, hormone level abnormal and depression had not resolved.The reporter considered alopecia, aplastic anaemia, depression, headache, hormone level abnormal, hypertension, migraine, pelvic pain, raynaud's phenomenon, rheumatoid arthritis, tooth disorder, urinary tract infection, vulvovaginal mycotic infection and weight decreased to be related to essure.The reporter commented: coil appears to be in the tube and not in the uterus.The patient counseled on only 1 essure device being placed and on the inflamed appearance of the uterine activity at time of hs that prevented the placing a 2nd essure.Pt understands and still wishes to have permanent sterilization.5mm laparoscope placed through umbilicus using direct view technique.Two accessory 5mm ports were placed one on right side and one on left side.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.6 kg/sqm.On (b)(6) 2011 sono performed by dr vincent at time of this visit and coil appears to be in the lube and not in the uterus.Concerning the injuries reported in this case, the following one/ones were confirm in patient¿s medical records: pelvic pain, urinary tract infection, migraine, alopecia, depression.Quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on (b)(6)2018: plaintiff fact sheet received.Reporter information, patient¿s demographic information, other relevant history updated.Outcome of events changed from "unknown" to "not recovered/not resolved" 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
• MDR Report Key: 7869125
• MDR Text Key: 120102407
• Report Number: 2951250-2018-03979
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2018

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: 09/01/2013
• Device Model Number: ESS305
• Device Lot Number: 787008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 09/14/2018; 10/30/2018
• Supplement Dates FDA Received: 09/17/2018; 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; AMLODIPINE; AMLODIPINE; IBUPROFEN; IBUPROFEN; IBUPROFEN; IRON SUPPLEMENT; IRON SUPPLEMENT; IRON SUPPLEMENT; METOPROLOL; METOPROLOL; METOPROLOL; OMEPRAZOLE; OMEPRAZOLE; OMEPRAZOLE; RELPAX; RELPAX; RELPAX
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 86