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

Model Number ESS305

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Headache (1880); Inflammation (1932); Pain (1994); Uterine Perforation (2121); Vomiting (2144); Dizziness (2194); Confusion/ Disorientation (2553); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of device breakage ("x-ray showed one of the coils had straightened out and broke inside my pelvis"), pelvic pain ("severe pelvic pain during and after intercourse") and polyarthritis ("inflammation of all my joints") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "showed one of the coils had straightened out and broke inside my pelvis".On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), syncope ("dizziness and faint"), dizziness ("dizziness and faint"), pelvic pain (seriousness criteria hospitalization, disability, medically significant and intervention required), dyspareunia ("severe pelvic pain during and after intercourse"), dysmenorrhoea ("extremely painful periods"), migraine ("migraines"), polyarthritis (seriousness criterion medically significant), vomiting ("undiagnosed vomiting") and feeling abnormal ("extreme brain fog").The patient was treated with surgery to remove essure on (b)(6) 2018 hysterectomy, uterus, cervix and fallopian tubes removed to remove all essure parts).At the time of the report, the device breakage, syncope, dizziness, pelvic pain, dyspareunia, dysmenorrhoea, migraine, polyarthritis, vomiting and feeling abnormal outcome was unknown.The reporter provided no causality assessment for device breakage, dizziness, dysmenorrhoea, dyspareunia, feeling abnormal, migraine, pelvic pain, polyarthritis, syncope and vomiting with essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: one coil had straightened out and broke in pelvis 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 case was initially received via regulatory authority (fda, reference number: mw5077251) on 30-may-2018.The most recent information was received on 31-oct-2018.This spontaneous case was reported by a consumer and describes the occurrence of device breakage ("x-ray showed one of the coils had straightened out and broke inside my pelvis"), pelvic pain ("severe pelvic pain during and after intercourse") and polyarthritis ("inflammation of all my joints") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "showed one of the coils had straightened out and broke inside my pelvis".On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), syncope ("dizziness and faint"), dizziness ("dizziness and faint"), pelvic pain (seriousness criteria hospitalization, disability, medically significant and intervention required), dyspareunia ("severe pelvic pain during and after intercourse"), dysmenorrhoea ("extremely painful periods"), migraine ("migraines"), polyarthritis (seriousness criterion medically significant), vomiting ("undiagnosed vomiting") and feeling abnormal ("extreme brain fog").The patient was treated with surgery (on (b)(6) 2018 hysterectomy, uterus, cervix and fallopian tubes removed to remove all essure parts) and surgery (on (b)(6) 2018 hysterectomy, uterus, cervix and fallopian tubes removed to remove all essure parts).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, syncope, dizziness, pelvic pain, dyspareunia, dysmenorrhoea, migraine, polyarthritis, vomiting and feeling abnormal outcome was unknown.The reporter provided no causality assessment for device breakage, dizziness, dysmenorrhoea, dyspareunia, feeling abnormal, migraine, pelvic pain, polyarthritis, syncope and vomiting with essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: one coil had straightened out and broke in pelvis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 31-oct-2018: quality safety evaluation of ptc.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 case was initially received via regulatory authority (fda, reference number: mw5077251) on 30-may-2018.The most recent information was received on 22-aug-2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain during and after intercourse\ pain\ chronic pelvic pain'), device breakage ('x-ray showed one of the coils had straightened out and broke inside my pelvis'), uterine perforation ('migration/perforation /extrusion'), autoimmune disorder ('autoimmune-like symptoms'), genital haemorrhage ('bleeding\ heavy bleeding'), polyarthritis ('inflammation of all my joints') and neuromyopathy ('neuromuscular problems') in an adult 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 physical property issue "showed one of the coils had straightened out and broke inside my pelvis".The patient's medical history included fatigue, vaginal delivery and polyarthralgia.Previously administered products included for an unreported indication: paragard.Concurrent conditions included low back pain, neck pain, lumbar strain, neck strain, joint ache, stiffness, genital herpes, allergic rhinitis, hemorrhoids, mood disorder, dog bite, attention deficit-hyperactivity disorder, depression, anxiety, muscle pain, seasonal allergy, spasm of muscle, pain in hip, arthralgia, abdominal bloating, leg pain, itching, rash, perineal pain, adnexal mass, rotator cuff syndrome, shoulder pain, nausea, night sweats, vaginal dryness, lactose intolerance, nabothian cyst and headache.Family history included diabetes mellitus.Concomitant products included diclofenac sodium (anti-inflammatory), ibuprofen, oxycodone, paracetamol (acetaminophen) and tramadol.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization, disability, medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), polyarthritis (seriousness criterion medically significant), neuromyopathy (seriousness criterion medically significant), dyspareunia ("severe pelvic pain during and after intercourse\ dyspareunia\ pain with intercourse"), dysmenorrhoea ("extremely painful periods"), syncope ("dizziness and faint"), dizziness ("dizziness and faint"), migraine ("migraines"), vomiting ("undiagnosed vomiting"), feeling abnormal ("extreme brain fog") and arthralgia ("pain all over in joints") and was found to have weight increased ("weight gain").The patient was treated with surgery (total hysterectomy, uterus, cervix and fallopian tubes removed to remove all essure parts and total hysterectomy bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, device breakage, uterine perforation, autoimmune disorder, genital haemorrhage, polyarthritis, neuromyopathy, dyspareunia, dysmenorrhoea, syncope, dizziness, migraine, vomiting, feeling abnormal, weight increased and arthralgia outcome was unknown.The reporter provided no causality assessment for device breakage, dizziness, dysmenorrhoea, dyspareunia, feeling abnormal, migraine, polyarthritis, syncope and vomiting with essure.The reporter considered arthralgia, autoimmune disorder, genital haemorrhage, neuromyopathy, pelvic pain, uterine perforation and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: as per mr:- impression: expected appearance with essure devices appropriately positioned within the fallopian tubes bilaterally.No contrast travels beyond these devices.X-ray - on an unknown date: results: one coil had straightend out and broke in pelvis; on (b)(6) 2018: essure devices visible bi laterally in the pelvis.Concerning the injuries reported in this case, the following ones were described in patients medical record confirming: weight gain, dyspareunia, pain all over in joints, migraines.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-aug-2019: pfs and mr received: new events added- "migration/perforation/extrusion, bleeding,neuromuscular problems, autoimmune-like symptoms, migraines, weight gain, pain all over in joints", concomitant conditions & drugs, lab test, historical conditions were added.No lot number or device sample was received in this case.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, 13353 ; GM 13353
• MDR Report Key: 7569713
• MDR Text Key: 110114963
• Report Number: 2951250-2018-02497
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 10/31/2018; 08/22/2019
• Supplement Dates FDA Received: 10/31/2018; 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ANTI-INFLAMMATORY; IBUPROFEN; OXYCODONE; TRAMADOL
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability