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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Anemia (1706); Fatigue (1849); Memory Loss/Impairment (1958); Pregnancy (3193)

Event Date 01/01/2017

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on 24-feb-2020.This spontaneous case was reported by a consumer and describes the occurrence of pregnancy with contraceptive device ('pregnancy') in a (b)(6) year old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".On (b)(6) 2015, the patient had essure inserted.In 2017, the patient was found to have a pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced amnesia ("memory loss"), anaemia ("anaemia") and fatigue ("fatigue").The patient was treated with surgery (voluntary termination, salpingectomy, hysterectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pregnancy with contraceptive device, amnesia, anaemia and fatigue outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered amnesia, anaemia, fatigue and pregnancy with contraceptive device to be related to essure.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on (b)(6) 2020.This spontaneous case was reported by a consumer and describes the occurrence of pregnancy with contraceptive device ('pregnancy') in a 42-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".On (b)(6) 2015, the patient had essure inserted.In 2017, the patient was found to have a pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced amnesia ("memory loss"), anaemia ("anaemia") and fatigue ("fatigue").The patient was treated with surgery (voluntary termination, salpingectomy, hysterectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pregnancy with contraceptive device, amnesia, anaemia and fatigue outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered amnesia, anaemia, fatigue and pregnancy with contraceptive device to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-mar-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.

• 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: 9759685
• MDR Text Key: 189976144
• Report Number: 2951250-2020-01746
• 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: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• 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
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR