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

Model Number ESS305

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Emotional Changes (1831); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091); Urticaria (2278); Anxiety (2328); Arthralgia (2355); Irritability (2421); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of allergy to metals ("possible nickel allergy") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2017, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required) with eczema, urticaria, rash and pruritus, abdominal distension ("bloating"), diarrhoea ("diarrhea"), mood altered ("moody and irritable"), irritability ("moody and irritable"), sleep disorder ("problem sleeping"), arthralgia ("joint aching"), anxiety ("high anxiety") and alopecia ("hair loss").The patient will be treated with surgery (essure will be surgically removed on (b)(6) 2018).Essure treatment was not changed.At the time of the report, the allergy to metals, abdominal distension, diarrhoea, mood altered, irritability, sleep disorder, arthralgia, anxiety and alopecia outcome was unknown.The reporter provided no causality assessment for abdominal distension, allergy to metals, alopecia, anxiety, arthralgia, diarrhoea, irritability, mood altered and sleep disorder with essure.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 physician and describes the occurrence of allergy to metals ("possible nickel allergy") in a 38-year-old female patient who had essure (batch no.E36581) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii, parity 2, cervical dilatation and analgesia.Ectopics, c-section and previous gynaecological intervention were denied.On (b)(6) 2017, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required) with eczema, urticaria, rash and pruritus, abdominal distension ("bloating"), diarrhoea ("diarrhea"), mood altered ("moody and irritable"), irritability ("moody and irritable"), sleep disorder ("problem sleeping"), arthralgia ("joint aching"), anxiety ("high anxiety"), alopecia ("hair loss"), emotional disorder ("emotional nos"), pyrexia ("low grade fever"), mass ("bumps that leak fluid") and inflammation ("inflammation nos").The patient was treated with surgery (essure removal method: laparoscopic).Essure was removed on 3-jan-2018.At the time of the report, the allergy to metals, abdominal distension, diarrhoea, mood altered, irritability, sleep disorder, arthralgia, anxiety, alopecia, emotional disorder, pyrexia, mass and inflammation outcome was unknown.The reporter provided no causality assessment for abdominal distension, allergy to metals, alopecia, anxiety, arthralgia, diarrhoea, emotional disorder, inflammation, irritability, mass, mood altered, pyrexia and sleep disorder with essure.The reporter commented: she was not breast-feeding at time of insertion.Cervical dilatation, sounding and analgesia (ketorolac, norco, paracervical block lidocaine) were applied during insertion.The insertion and visualization of tubal os was easy, fluid loss during hysteroscopy was less than 1500cc and the procedure did not take more than 20min.She has no complaints immediately after insertion.No perforation of any organ or intra-abdominal structure occurred.Essure was removed because of patient request and it was medically necessary.Patient has no complaints of any issues since post op.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2017: tubal occlusion confirmed (b)(6) 2018: pathology result: inflammation.Most recent follow-up information incorporated above includes: on (b)(6) 2018: uterine tubal perforation with essure questionnaire was received.The following information were provided: patient¿s initials updated; patient demographic details; essure lot number e36581 and removal date; insertion details; emotional, low grade fever, bumps that leak fluid and inflammation were added as event; new lab data provided.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

This spontaneous case was reported by a physician and describes the occurrence of allergy to metals ("possible nickel allergy"), abdominal pain lower ("cramping") and genital haemorrhage ("spotting") in a 38-year-old female patient who had essure (batch no.E36581) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii, parity 2, cervical dilatation and analgesia.Ectopics, c-section and previous gynaecological intervention were denied.Concurrent conditions included allergy to metals.On (b)(6) 2017, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required) with eczema, urticaria, rash and pruritus, abdominal pain lower (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal distension ("bloating"), diarrhoea ("diarrhea"), mood altered ("moody and irritable"), irritability ("moody and irritable"), sleep disorder ("problem sleeping"), arthralgia ("joint aching"), anxiety ("high anxiety"), alopecia ("hair loss"), emotional disorder ("emotional nos"), pyrexia ("low grade fever"), rash pustular ("bumps that leak fluid") and inflammation ("inflammation nos").The patient was treated with surgery (essure removal method: laparoscopic) and surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the allergy to metals, abdominal pain lower, genital haemorrhage, abdominal distension, diarrhoea, mood altered, irritability, sleep disorder, arthralgia, anxiety, alopecia, emotional disorder, pyrexia, rash pustular and inflammation outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, diarrhoea, emotional disorder, genital haemorrhage, inflammation, irritability, mood altered, pyrexia, rash pustular and sleep disorder with essure.The reporter commented: she was not breast-feeding at time of insertion.Cervical dilatation, sounding and analgesia (ketorolac, norco, paracervical block lidocaine) were applied during insertion.The insertion and visualization of tubal os was easy, fluid loss during hysteroscopy was less than 1500cc and the procedure did not take more than 20 min.She has no complaints immediately after insertion.No perforation of any organ or intra-abdominal structure occurred.Essure was removed because of patient request and it was medically necessary.Patient has no complaints of any issues since post op.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2017: tubal occlusion confirmed (b)(6) 2018: pathology result: inflammation.Most recent follow-up information incorporated above includes: on 17-jul-2018: new events added- cramping and spotting.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

This spontaneous case was reported by a physician and describes the occurrence of allergy to metals ("possible nickel allergy"), abdominal pain lower ("cramping") and genital haemorrhage ("spotting") in a 38-year-old female patient who had essure (batch no.E36581) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii, parity 2, cervical dilatation and analgesia.Ectopics, c-section and previous gynaecological intervention were denied.Concurrent conditions included allergy to metals.On (b)(6) 2017, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required) with eczema, urticaria, rash and pruritus, abdominal pain lower (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal distension ("bloating"), diarrhoea ("diarrhea"), mood altered ("moody and irritable"), irritability ("moody and irritable"), sleep disorder ("problem sleeping"), arthralgia ("joint aching"), anxiety ("high anxiety"), alopecia ("hair loss"), emotional disorder ("emotional nos"), pyrexia ("low grade fever"), rash pustular ("bumps that leak fluid") and inflammation ("inflammation nos").The patient was treated with surgery (essure removal method: laparoscopic) and surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the allergy to metals, abdominal pain lower, genital haemorrhage, abdominal distension, diarrhoea, mood altered, irritability, sleep disorder, arthralgia, anxiety, alopecia, emotional disorder, pyrexia, rash pustular and inflammation outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, diarrhoea, emotional disorder, genital haemorrhage, inflammation, irritability, mood altered, pyrexia, rash pustular and sleep disorder with essure.The reporter commented: she was not breast-feeding at time of insertion.Cervical dilatation, sounding and analgesia (ketorolac, norco, paracervical block lidocaine) were applied during insertion.The insertion and visualization of tubal os was easy, fluid loss during hysteroscopy was less than 1500cc and the procedure did not take more than 20min.She has no complaints immediately after insertion.No perforation of any organ or intra-abdominal structure occurred.Essure was removed because of patient request and it was medically necessary.Patient has no complaints of any issues since post op.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.2 kg/sqm.Hysterosalpingogram - on 30-aug-2017: tubal occlusion confirmed.03-jan-2018: pathology result: inflammation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-jul-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.

• 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: 7128059
• MDR Text Key: 95191272
• Report Number: 2951250-2017-10913
• 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: health professional,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: ESS305
• Device Lot Number: E36581
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 72