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

Model Number ESS305

Device Problems Device Inoperable (1663); Patient-Device Incompatibility (2682); Positioning Problem (3009); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Menstrual Irregularities (1959); Miscarriage (1962); Uterine Perforation (2121); Anxiety (2328); Depression (2361); Foreign Body In Patient (2687); Pregnancy (3193)

Event Date 12/24/2015

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("displaced essure device"), pregnancy with contraceptive device ("pregnant") and stillbirth ("stillbirth") in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".In 2010, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant), stillbirth (seriousness criterion medically significant), pelvic pain ("pelvic pain"), dysmenorrhoea ("dysmenorrhea"), menorrhagia ("menorrhagia"), anxiety ("anxious") and depression ("depressed").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (robotic hysterectomy with bilateral salpingectomy and cystoscopy with removal of the essure devices).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, pregnancy with contraceptive device, stillbirth, pelvic pain, dysmenorrhoea, menorrhagia, anxiety and depression outcome was unknown.The pregnancy outcome was reported as stillbirth.The reporter considered anxiety, depression, device dislocation, dysmenorrhoea, menorrhagia, pelvic pain, pregnancy with contraceptive device and stillbirth to be related to essure.The reporter commented: plaintiff became pregnant and delivered a stillborn child at approximately 19 weeks.She sought treatment on multiple occasions.Further company follow-up with the consumer, lawyer or lawyer 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 spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("migration of essure location of device: pelvis; myometrium / embedded essure"), device expulsion ("migration of essure location of device: pelvis; myometrium"), stillbirth ("stillbirth"), pregnancy with contraceptive device ("pregnant") and haemorrhage in pregnancy ("complication of pregnancy - blood loss") in a 29-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".The patient's medical history included parity 2 (live birth: (b)(6) 2004 and (b)(6) 2010).Previously administered products included for an unreported indication: yaz from 2009 to 2010 and ortho-tri cyclen from 2007 to 2009.Concurrent conditions included subchorionic haemorrhage.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2011, the patient experienced pelvic pain ("pelvic pain/ pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), menorrhagia ("menorrhagia/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), fatigue ("fatigue"), abdominal pain lower ("pain: lower right abdominal") and nausea ("nausea"), 2 months 14 days after insertion of essure.In (b)(6) 2013, the patient experienced stillbirth (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced embedded device (seriousness criteria medically significant and intervention required) and device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and experienced haemorrhage in pregnancy (seriousness criteria hospitalization and medically significant), anxiety ("anxious"), depression ("depressed") and abdominal pain ("abdominal pain").The patient was treated with surgery (robotic hysterectomy with bilateral salpingectomy and cystoscopy with removal of the essure devices) and blood transfusion.Essure was removed on (b)(6) 2016.At the time of the report, the embedded device, device expulsion, stillbirth, pregnancy with contraceptive device, haemorrhage in pregnancy, pelvic pain, dysmenorrhoea, anxiety, depression, fatigue and nausea outcome was unknown and the menorrhagia, vaginal haemorrhage, abdominal pain lower and abdominal pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 3, para 2.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the second trimester.The pregnancy outcome was reported as stillbirth.The reporter considered abdominal pain, abdominal pain lower, anxiety, depression, device expulsion, dysmenorrhoea, embedded device, fatigue, haemorrhage in pregnancy, menorrhagia, nausea, pelvic pain, pregnancy with contraceptive device, stillbirth and vaginal haemorrhage to be related to essure.The reporter commented: plaintiff became pregnant and delivered a stillborn child at approximately 19 weeks.She sought treatment on multiple occasions.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.Pregnancy test - on (b)(6) 2013: positive.Ultrasound scan vagina - (b)(6) 2012: result: the uterus is retroverted and appears normal.The ovaries appear normal with a residual follicle seen on the right ovary.The endometrial lining appears normal there was free fluid seen in the cul-de sac.There are echogenic structures seen in the cornual region of the uterus consistent with the essure tubal.¿concerning the injuries reported in this case, the following ones were described in patients medical record: menorrhagia, embedded device, pregnant with essure micro-insert and vaginal hemorrhage." further company follow-up with the consumer, lawyer or lawyer is not possible.Most recent follow-up information incorporated above includes: on 6-feb-2019: reporter information was added.This case is medically confirmed.This case concerns 29 year old patient.Her demographics were updated.Her historical medication/ condition and concurrent condition were added.Lab data was added.Essure indication was amended.Essure insertion date was added.Per plaintiff fact sheet following events: event displaced essure device (device dislocation) updated to migration of essure location of device: pelvis; myometrium (device embedment and device expulsion), abnormal bleeding (vaginal); fatigue, nausea; pain: lower right abdominal and abdominal pain were added.She had recovered from abdominal pain, menorrhagia/abnormal bleeding.Incident: 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: 7396281
• MDR Text Key: 104407883
• Report Number: 2951250-2018-01464
• 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
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR