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 Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Swelling (2091); Tachycardia (2095); Blurred Vision (2137); Dizziness (2194)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("abdominal pain") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2016, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), arthralgia ("important joint pain"), rotator cuff syndrome ("shoulder tendinitis"), tendonitis ("hip tendinitis"), abdominal distension ("ballooning"), blindness ("vision loss"), vision blurred ("blurred vision"), diarrhoea ("diarrhoea"), dizziness ("dizziness"), tachycardia ("tachycardia"), metrorrhagia ("blood loss outside of menstrual periods"), fatigue ("strong fatigue"), immunodeficiency ("low immunity"), swelling face ("swollen face") and swelling ("swollen body").The patient was treated with surgery (device removal by salpingectomy and hysterectomy on (b)(6) 2018.).Essure was removed on (b)(6) 2018.At the time of the report, the abdominal pain, arthralgia, rotator cuff syndrome, tendonitis, abdominal distension, blindness, vision blurred, diarrhoea, dizziness, tachycardia, metrorrhagia, fatigue, immunodeficiency, swelling face and swelling outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, arthralgia, blindness, diarrhoea, dizziness, fatigue, immunodeficiency, metrorrhagia, rotator cuff syndrome, swelling, swelling face, tachycardia, tendonitis and vision blurred with essure.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 23-may-2018 for the following meddra preferred term: abdominal pain- analysis in the global safety database revealed 2.229 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Further company follow-up with the consumer or regulatory authority is not possible.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 (ansm, reference number: (b)(4)) on 22-may-2018.The most recent information was received on 26-jun-2018.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("abdominal pain") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2016, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), arthralgia ("important joint pain"), rotator cuff syndrome ("shoulder tendinitis"), tendonitis ("hip tendinitis"), abdominal distension ("ballooning"), blindness ("vision loss"), vision blurred ("blurred vision"), diarrhoea ("diarrhoea"), dizziness ("dizziness"), tachycardia ("tachycardia"), metrorrhagia ("blood loss outside of menstrual periods"), fatigue ("strong fatigue"), immunodeficiency ("low immunity"), swelling face ("swollen face") and swelling ("swollen body").The patient was treated with surgery (device removal by salpingectomy and hysterectomy on (b)(6) 2018.).Essure was removed on (b)(6) 2018.At the time of the report, the abdominal pain, arthralgia, rotator cuff syndrome, tendonitis, abdominal distension, blindness, vision blurred, diarrhoea, dizziness, tachycardia, metrorrhagia, fatigue, immunodeficiency, swelling face and swelling outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, arthralgia, blindness, diarrhoea, dizziness, fatigue, immunodeficiency, metrorrhagia, rotator cuff syndrome, swelling, swelling face, tachycardia, tendonitis and vision blurred with essure.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: abdominal pain- analysis in the global safety database revealed 2.292cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 26-jun-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.

• 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: 7538500
• MDR Text Key: 109065904
• Report Number: 2951250-2018-02357
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

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 Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention