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 Autoimmune Disorder (1732); Death, Intrauterine Fetal (1855); Hypersensitivity/Allergic reaction (1907); Pain (1994); Uterine Perforation (2121); Reaction (2414); Foreign Body In Patient (2687); No Code Available (3191); Pregnancy (3193)

Event Type  Injury  

Event Description

"rospective" pregnancy case describes the occurrence of fallopian tube perforation ("perforation of fallopian tubes"), uterine perforation ("perforation of uterus"), device dislocation ("inserts moving into the abdomen or pelvic cavity"), pregnancy with contraceptive device ("pregnancy with essure"), foetal death ("foetal death") and autoimmune disorder ("autoimmune issues") in a unspecified number of female patients who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".On an unknown date, the patients had essure inserted.On an unknown date, the patients experienced fallopian tube perforation (seriousness criterion medically significant), uterine perforation (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), pregnancy with contraceptive device (seriousness criterion medically significant), foetal death (seriousness criterion medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), pelvic pain ("persistent pain") and hypersensitivity ("suspected allergic reactions").At the time of the report, the fallopian tube perforation, uterine perforation, device dislocation, pregnancy with contraceptive device, foetal death, autoimmune disorder, pelvic pain and hypersensitivity outcomes were unknown.The pregnancy outcomes were reported as fetal death.The reporter considered autoimmune disorder, device dislocation, fallopian tube perforation, foetal death, hypersensitivity, pelvic pain, pregnancy with contraceptive device and uterine perforation to be related to essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred terms: fallopian tube perforation: 1.735 cases.Uterine perforation: 1.641 cases.Device dislocation: 3.699 cases.Foetal death: 15 cases.Pregnancy with contraceptive device: 4.557 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 these meddra pts.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 retrospective pregnancy case was reported by an other and describes the occurrence of fallopian tube perforation ("perforation of fallopian tubes"), uterine perforation ("perforation of uterus"), device dislocation ("inserts moving into the abdomen or pelvic cavity"), pregnancy with contraceptive device ("pregnancy with essure"), foetal death ("foetal death") and autoimmune disorder ("autoimmune issues") 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 ineffective "device ineffective".On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced fallopian tube perforation (seriousness criterion medically significant), uterine perforation (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), pregnancy with contraceptive device (seriousness criterion medically significant), fetal death (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), pelvic pain ("persistent pain") and hypersensitivity ("suspected allergic reactions").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.At the time of the report, the fallopian tube perforation, uterine perforation, device dislocation, pregnancy with contraceptive device, fetal death, autoimmune disorder, pelvic pain and hypersensitivity outcome was unknown.The pregnancy outcome was reported as fetal death.The reporter considered autoimmune disorder, device dislocation, fallopian tube perforation, foetal death, hypersensitivity, pelvic pain, pregnancy with contraceptive device and uterine perforation to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-nov-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: 7786422
• MDR Text Key: 117257696
• Report Number: 2951250-2018-03547
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• 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: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention