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

Model Number ESS305

Device Problems Biocompatibility (2886); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Perforation (2001); Rash (2033); Uterine Perforation (2121); Vomiting (2144); Dizziness (2194); Arthralgia (2355); Depression (2361); Neck Pain (2433); Sleep Dysfunction (2517); Abdominal Cramps (2543); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2017

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("lodging of one essure coil into her uterus") and device expulsion ("lodging of one essure coil into her uterus") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: menstrual periods were not nearly as heavy nor did they last as long before essure insertion, and she had no problem about her daily life.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2016, the patient experienced musculoskeletal pain ("shoulder pain"), headache ("headaches"), dizziness ("dizziness") and neck pain ("neck pain").In january 2017, the patient experienced asthenia ("decreased energy level") and poor quality sleep ("sleeping poorly").In (b)(6) 2017, the patient experienced diarrhoea ("diarrhea").On (b)(6) 2017, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain / bouts of abdominal cramping"), menorrhagia ("menorrhagia"), fatigue ("extreme fatigue"), back pain ("back pain"), nausea ("nausea"), vomiting ("vomiting"), motion sickness ("motion sickness"), hypersensitivity ("allergic reactions"), depression ("depression"), arthralgia ("joint pain") and rash ("various skin rashes").The patient was treated with surgery (total laparoscopic hysterectomy with bilateral salpingectomy) and surgery (total laparoscopic hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the embedded device, musculoskeletal pain, arthralgia, rash, headache, dizziness, asthenia and poor quality sleep outcome was unknown and the device expulsion, abdominal pain, menorrhagia, fatigue, back pain, nausea, motion sickness, hypersensitivity, depression, diarrhoea and neck pain had not resolved.The reporter considered abdominal pain, arthralgia, asthenia, back pain, depression, device expulsion, diarrhoea, dizziness, embedded device, fatigue, headache, hypersensitivity, menorrhagia, motion sickness, musculoskeletal pain, nausea, neck pain, poor quality sleep, rash and vomiting to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): colonoscopy - on (b)(6) 2017: possible eosinophilic esophagitis, pending biopsy; ultrasound pelvis - on (b)(6) -2017: lodging of one of the essure coils into her uteru.Most recent follow-up information incorporated above includes: on 29-mar-2018: essure insertion date ((b)(6) 2015) was provided.The events ¿joint pain¿, ¿various skin rashes¿, ¿headaches¿, ¿dizziness¿, ¿shoulder pain¿, ¿decreased energy level¿ and ¿sleeping poorly¿ were added.Essure removal date ((b)(6) 2017) and procedure were provided.Incident: no lot number or sample available for investigation.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

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ('perforation / migration'), embedded device ('lodging of one essure coil into her uterus/migration') and device expulsion ('lodging of one essure coil into her uterus') in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Medical conditions: menstrual periods were not nearly as heavy nor did they last as long before essure insertion, and she had no problem about her daily life.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2016, the patient experienced musculoskeletal pain ("shoulder pain"), headache ("headaches"), dizziness ("dizziness") and neck pain ("neck pain").In (b)(6) 2017, the patient experienced asthenia ("decreased energy level") and poor quality sleep ("sleeping poorly").In (b)(6) 2017, the patient experienced diarrhoea ("diarrhea").On (b)(6) 2017, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain / bouts of abdominal cramping/worsening of pain"), menorrhagia ("menorrhagia"), fatigue ("extreme fatigue"), back pain ("back pain"), nausea ("nausea"), vomiting ("vomiting"), motion sickness ("motion sickness"), allergic reaction ("allergic reactions"), depression ("depression"), arthralgia ("joint pain"), rash ("various skin rashes"), migraine ("migraines/headaches"), hypersensitivity symptom ("hypersensitivity symptoms"), genital haemorrhage ("abnormal uterine bleeding"), autoimmune disorder ("autoimmune symptoms"), allergy to metals ("allergic to nickel / hypersensitivity") and pelvic pain ("pain").The patient was treated with surgery (total laparoscopic hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the perforation, embedded device, musculoskeletal pain, arthralgia, rash, headache, dizziness, asthenia, poor quality sleep, migraine, hypersensitivity symptom, genital haemorrhage, autoimmune disorder, allergy to metals and pelvic pain outcome was unknown and the device expulsion, abdominal pain, menorrhagia, fatigue, back pain, nausea, motion sickness, allergic reaction, depression, diarrhoea and neck pain had not resolved.The reporter considered abdominal pain, allergic reaction, allergy to metals, arthralgia, asthenia, autoimmune disorder, back pain, depression, device expulsion, diarrhoea, dizziness, embedded device, fatigue, genital haemorrhage, headache, menorrhagia, migraine, motion sickness, musculoskeletal pain, nausea, neck pain, pelvic pain, perforation, poor quality sleep, rash, vomiting and hypersensitivity symptom to be related to essure.The reporter commented: one of her essure devices lodged itself into her uterus.Patch test: allergy to nickel.Diagnostic results (normal ranges are provided in parenthesis if available): colonoscopy - on (b)(6) 2017: results: possible eosinophilic esophagitis, pending biopsy.Ultrasound pelvis - on (b)(6) 2017: results: lodging of one of the essure coils into her uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 19-sep-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ('perforation / migration'), embedded device ('lodging of one essure coil into her uterus/migration') and device expulsion ('lodging of one essure coil into her uterus') in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Medical conditions: menstrual periods were not nearly as heavy nor did they last as long before essure insertion, and she had no problem about her daily life.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2016, the patient experienced musculoskeletal pain ("shoulder pain"), headache ("headaches"), dizziness ("dizziness") and neck pain ("neck pain").In (b)(6) 2017, the patient experienced asthenia ("decreased energy level") and poor quality sleep ("sleeping poorly").In (b)(6) 2017, the patient experienced diarrhea ("diarrhea").On (b)(6) 2017, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain / bouts of abdominal cramping/worsening of pain"), menorrhagia ("menorrhagia"), fatigue ("extreme fatigue"), back pain ("back pain"), nausea ("nausea"), vomiting ("vomiting"), motion sickness ("motion sickness"), allergic reaction ("allergic reactions"), depression ("depression"), arthralgia ("joint pain"), rash ("various skin rashes"), migraine ("migraines/headaches"), hypersensitivity symptom ("hypersensitivity symptoms"), genital hemorrhage ("abnormal uterine bleeding"), autoimmune disorder ("autoimmune symptoms"), allergy to metals ("allergic to nickel / hypersensitivity") and pelvic pain ("pain").The patient was treated with surgery (total laparoscopic hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the perforation, embedded device, musculoskeletal pain, arthralgia, rash, headache, dizziness, asthenia, poor quality sleep, migraine, hypersensitivity symptom, genital hemorrhage, autoimmune disorder, allergy to metals and pelvic pain outcome was unknown and the device expulsion, abdominal pain, menorrhagia, fatigue, back pain, nausea, motion sickness, allergic reaction, depression, diarrhea and neck pain had not resolved.The reporter considered abdominal pain, allergic reaction, allergy to metals, arthralgia, asthenia, autoimmune disorder, back pain, depression, device expulsion, diarrhea, dizziness, embedded device, fatigue, genital hemorrhage, headache, menorrhagia, migraine, motion sickness, musculoskeletal pain, nausea, neck pain, pelvic pain, perforation, poor quality sleep, rash, vomiting and hypersensitivity symptom to be related to essure.The reporter commented: one of her essure devices lodged itself into her uterus.Patch test: allergy to nickel.Diagnostic results (normal ranges are provided in parenthesis if available): colonoscopy - on (b)(6) 2017: results: possible eosinophilic esophagitis, pending biopsy.Ultrasound pelvis - on (b)(6) 2017: results: lodging of one of the essure coils into her uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-aug-2020: pif received.Events "perforation, abnormal bleeding, pelvic pain female, auto-immune symptoms and hypersensitivity symptoms/ nickel allergy" added.Essure indication was added.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ('perforation / migration'), embedded device ('lodging of one essure coil into her uterus/migration') and device expulsion ('lodging of one essure coil into her uterus') in a 31-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included cervicitis and paratubal cyst.Menstrual periods were not nearly as heavy nor did they last as long before essure insertion, and she had no problem about her daily life.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2016, the patient experienced shoulder pain ("shoulder pain"), headache ("headaches"), dizziness ("dizziness") and neck pain ("neck pain").In (b)(6) 2017, the patient experienced asthenia ("decreased energy level") and poor quality sleep ("sleeping poorly").In (b)(6) 2017, the patient experienced diarrhoea ("diarrhea").On (b))(6) 2017, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain / bouts of abdominal cramping/worseining of pain"), heavy menstrual bleeding ("menorrhagia"), fatigue ("extreme fatigue"), back pain ("back pain"), nausea ("nausea"), vomiting ("vomiting"), motion sickness ("motion sickness"), allergic reaction ("allergic reactions"), depression ("depression"), joint pain ("joint pain"), rash ("various skin rashes"), migraine ("migraines/headaches"), hypersensitivity symptom ("hypersensitivity symptoms"), genital haemorrhage ("abnormal uterine bleeding"), autoimmune disorder ("autoimune symptoms"), allergy to metals ("allergic to nickel / hypersensitivity") and pelvic pain ("pain").The patient was treated with surgery (total laparoscopic hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the perforation, embedded device, shoulder pain, joint pain, rash, headache, dizziness, asthenia, poor quality sleep, migraine, hypersensitivity symptom, genital haemorrhage, autoimmune disorder, allergy to metals and pelvic pain outcome was unknown and the device expulsion, abdominal pain, heavy menstrual bleeding, fatigue, back pain, nausea, motion sickness, allergic reaction, depression, diarrhoea and neck pain had not resolved.The reporter considered abdominal pain, allergic reaction, allergy to metals, asthenia, autoimmune disorder, back pain, depression, device expulsion, diarrhoea, dizziness, embedded device, fatigue, genital haemorrhage, headache, heavy menstrual bleeding, migraine, motion sickness, nausea, neck pain, pelvic pain, perforation, poor quality sleep, rash, shoulder pain, vomiting, hypersensitivity symptom and joint pain to be related to essure.The reporter commented: one of her essure devices lodged itself into her uterus.Patch test: allergy to nickel.The essure implants were deployed per manufacturer guidelines with 4 trailing coils noted on right and 4 trailing coils noted on left.Diagnostic results (normal ranges are provided in parenthesis if available): colonoscopy - on (b)(6) 2017: results: possible eosinophilic esophagitis, pending biopsy.Ultrasound pelvis - on (b)(6) 2017: results: lodging of one of the essure coils into her uteru.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-jun-2021: mr received.Reporter information, patient details , other relevant history added and rcc was updated.Based on the available information, a review of our complaint records and other relevant data was 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: 7422957
• MDR Text Key: 105244357
• Report Number: 2951250-2018-01693
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR