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

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracture of device") and genital haemorrhage ("abnormal bleeding") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and pelvic pain ("pain").The patient was treated with surgery (to remove the essure implant).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, genital haemorrhage and pelvic pain outcome was unknown.The reporter considered device breakage, genital haemorrhage and pelvic pain to be related to 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

Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracture of device") and genital haemorrhage ("abnormal bleeding") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "she did not undergo essure confirmation test".On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and pelvic pain ("pain").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, genital haemorrhage and pelvic pain outcome was unknown.The reporter considered device breakage, genital haemorrhage and pelvic pain to be related to essure.Most recent follow-up information incorporated above includes: on 13-jun-2018: pfs received: reporter information updated.Plaintiff demography added.Product indication added new events added: patient did not undergo essure confirmation test.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

Contaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracture of device"), genital haemorrhage ("abnormal bleeding") and oophoritis ("infection in ovaries") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's past medical history included multi gravida, parity 2 and recurrent abortion (2).On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced hypertension ("blood or heart disorder/condition type: high blood pressure,").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("pain"), oophoritis (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia),"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia),"), anxiety ("psychological or psychiatric problems condition: anxiety"), rash ("rashes or skin conditions type: rash or hives"), urticaria ("rashes or skin conditions type: rash or hives"), migraine ("migraines / headaches"), headache ("migraines / headaches"), constipation ("gastrointestinal or digestive system condition type: constipation"), weight increased ("weight gain") and adnexa uteri pain ("ovaries area pain").The patient was treated with ibuprofen, medroxyprogesterone (depo provera) and surgery (salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, genital haemorrhage, vaginal haemorrhage, menorrhagia, anxiety, rash, urticaria, migraine, constipation and weight increased outcome was unknown, the pelvic pain, oophoritis, hypertension and adnexa uteri pain had resolved and the headache was resolving.The reporter considered adnexa uteri pain, anxiety, constipation, device breakage, genital haemorrhage, headache, hypertension, menorrhagia, migraine, oophoritis, pelvic pain, rash, urticaria, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2013: total bilateral occlusion most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received: events abnormal bleeding (vaginal, menorrhagia), infection (bladder/ urinary tract/vaginal), type: infection in ovaries, psychological or psychiatric problems condition: anxiety, rashes or skin conditions type: rash or hives, migraines / headaches, blood or heart disorder/condition type: high blood pressure, weight gain, gastrointestinal or digestive system condition type: constipation were added.Concomitant drugs, historical condition were added.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: 7088474
• MDR Text Key: 93898660
• Report Number: 2951250-2017-10083
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention