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

Model Number ESS305

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Fever (1858); Headache (1880); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Vomiting (2144); Arthralgia (2355); Abdominal Cramps (2543); Weight Changes (2607)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain/ bilateral pelvic pain that was sharp and constant/ chronic pelvic pain/ chronic pain") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced abdominal pain lower ("abdominal cramping/ intermittent episodes of cramping/ abdominal cramps/ cramps/ right lower quadrant sensitivity and bilateral pain"), diarrhoea ("diarrhea"), pyrexia ("a fever of 101 degree f"), vomiting ("vomiting") and nausea ("nausea").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), arthralgia ("joint pain"), weight increased ("weight gain"), fatigue ("fatigue"), amenorrhoea ("amenorrhea"), migraine ("migraines"), vaginal haemorrhage ("vaginal bleeding"), vaginal discharge ("brown vaginal discharge"), pain in extremity ("leg pain"), pain ("full body hurts"), abdominal pain ("sharp, stabbing abdominal pain /abdominal pain"), menstruation irregular ("irregular menses") and dysmenorrhoea ("dysmenorrhea").The patient was treated with total abdominal hysterectomy with removal of the essure devices on (b)(6) 2014.At the time of the report, the pelvic pain, arthralgia, weight increased, fatigue, amenorrhoea, migraine, abdominal pain lower, diarrhoea, pyrexia, vomiting, nausea, vaginal haemorrhage, vaginal discharge, pain in extremity, pain, menstruation irregular and dysmenorrhoea outcome was unknown and the abdominal pain had not resolved.The reporter considered abdominal pain, abdominal pain lower, amenorrhoea, arthralgia, diarrhoea, dysmenorrhoea, fatigue, menstruation irregular, migraine, nausea, pain, pain in extremity, pelvic pain, pyrexia, vaginal discharge, vaginal haemorrhage, vomiting and weight increased to be related to essure.The reporter commented: plaintiff underwent a pelvic ultrasound that showed the essure devices to be properly positioned, and was prescribed flagyl and naproxen.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: occlusion was viewed in both fallopian tubes ultrasound pelvis - on an unknown date: showed essure devices to be properly positioned ultrasound scan vagina - on (b)(6) 2014: revealed a right ovarian cyst according to pathology report, no fallopian tubes were submitted to the pathologist, just the ¿stubs.¿ a ¿spring like insertion¿ was visible in the stub of the left fallopian tube.The report further states: ¿dissection of the right fallopian tube also reveals the presence of a spring-like occlusive device.¿ the microscopic description noted: ¿sections of the parametrium and tubal stubs in the vicinity of the uterine cornu reveal focal mild chronic inflammation with associated scan foreign body giant cell inflammation.¿ 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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981
• MDR Report Key: 7055285
• MDR Text Key: 92845138
• Report Number: 2951250-2017-07029
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2017

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention