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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Muscle Spasm(s) (1966); Pain (1994); Tinnitus (2103); Visual Impairment (2138); Burning Sensation (2146); Myalgia (2238); Discomfort (2330); Arthralgia (2355); Numbness (2415); Abdominal Cramps (2543); Nervous System Injury (2689)

Event Date 07/01/2013

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 03-may-2018.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("cramps"), female sterilisation ("additional sterilization on the right tube via laparoscopy"), hemiparaesthesia ("paresthesia on right half-body") and chronic fatigue syndrome ("disabling chronic fatigue syndrome") 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.In 2013, the patient experienced visual impairment ("visual disorders") and nervous system disorder ("neurologic disorders").In (b)(6) 2013, the patient underwent female sterilisation (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), chronic fatigue syndrome (seriousness criterion medically significant), allergy to metals ("clinical state of patient might led to conclude to intolerance to nickel, titanium or polyethylene"), pain ("pain"), gastric disorder ("stomach disorders"), arthralgia ("joint pain / joint pain on shoulders, wrists, hips, knees and ankles"), myalgia ("muscular pain / muscular pain in neck, back, arms and legs"), ear disorder ("orl disorders - ear disorder"), tinnitus ("tinnitus"), lacrimation increased ("continuous crying, eyelid spasms"), blepharospasm ("eyelid spasms"), hypoaesthesia ("numbing"), burning sensation ("continuous burning sensation") and oropharyngeal discomfort ("orl disorders -nose and throat disorder").In (b)(6) 2015, the patient experienced hemiparaesthesia (seriousness criterion hospitalization).The patient was treated with surgery (total hysterectomy with conservation of adnexa in 2015) and surgery (additional laparoscopic sterilization of right tube).At the time of the report, the abdominal pain, hemiparaesthesia, chronic fatigue syndrome, allergy to metals, pain, visual impairment, nervous system disorder, gastric disorder, arthralgia, myalgia, ear disorder, tinnitus, lacrimation increased, blepharospasm, hypoaesthesia, burning sensation and oropharyngeal discomfort outcome was unknown.The reporter provided no causality assessment for abdominal pain, allergy to metals, arthralgia, blepharospasm, burning sensation, chronic fatigue syndrome, ear disorder, female sterilisation, gastric disorder, hemiparaesthesia, hypoaesthesia, lacrimation increased, myalgia, nervous system disorder, oropharyngeal discomfort, pain, tinnitus and visual impairment with essure.The reporter commented: first essure insertion in (b)(6) 2013, followed by additional sterilization in (b)(6) 2013 on the right tube via laparoscopy.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term (pt).In this particular case a search in the global safety database was performed on 04-may-2018 for the following meddra pt (excluding this case): abdominal pain: 2165 cases were identified.Female sterilisation: 2 cases were identified.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.Further company follow-up with the regulatory authority is not possible.Incident.No lot number or sample was 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 in a supplemental report.

Manufacturer Narrative

E was initially received via regulatory authority (ansm, reference number: r1806052) on (b)(6) 2018.The most recent information was received on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("cramps"), female sterilisation ("additional sterilization on the right tube via laparoscopy"), hemiparaesthesia ("paresthesia on right half-body") and chronic fatigue syndrome ("disabling chronic fatigue syndrome") 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.In 2013, the patient experienced visual impairment ("visual disorders") and nervous system disorder ("neurologic disorders").In july 2013, the patient underwent female sterilisation (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), chronic fatigue syndrome (seriousness criterion medically significant), allergy to metals ("clinical state of patient might led to conclude to intolerance to nickel, titanium or polyethylene"), pain ("pain"), gastric disorder ("stomach disorders"), arthralgia ("joint pain / joint pain on shoulders, wrists, hips, knees and ankles"), myalgia ("muscular pain / muscular pain in neck, back, arms and legs"), ear disorder ("orl disorders - ear disorder"), tinnitus ("tinnitus"), lacrimation increased ("continuous crying, eyelid spasms"), blepharospasm ("eyelid spasms"), hypoaesthesia ("numbing"), burning sensation ("continuous burning sensation") and oropharyngeal discomfort ("orl disorders -nose and throat disorder").In february 2015, the patient experienced hemiparaesthesia (seriousness criterion hospitalization).The patient was treated with surgery (total hysterectomy with conservation of adnexa in 2015) and surgery (additional laparoscopic sterilization of right tube).At the time of the report, the abdominal pain, hemiparaesthesia, chronic fatigue syndrome, allergy to metals, pain, visual impairment, nervous system disorder, gastric disorder, arthralgia, myalgia, ear disorder, tinnitus, lacrimation increased, blepharospasm, hypoaesthesia, burning sensation and oropharyngeal discomfort outcome was unknown.The reporter provided no causality assessment for abdominal pain, allergy to metals, arthralgia, blepharospasm, burning sensation, chronic fatigue syndrome, ear disorder, female sterilisation, gastric disorder, hemiparaesthesia, hypoaesthesia, lacrimation increased, myalgia, nervous system disorder, oropharyngeal discomfort, pain, tinnitus and visual impairment with essure.The reporter commented: first essure insertion in apr 2013, followed by additional sterilization in jul 2013 on the right tube via laparoscopy.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term (pt).In this particular case a search in the global safety database was performed on (b)(6) 2018 for the following meddra pt (excluding this case): abdominal pain: 2165 cases were identified.Female sterilisation: 2 cases were identified.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.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2018: this case was identified as a follow-up of case (b)(4).All the information of this case was processed as follow-up in the case (b)(4).As a consequence, this case should be deleted.Incident: no lot number or sample was 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 in 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: 7486480
• MDR Text Key: 107352485
• Report Number: 2951250-2018-02030
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

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: 05/03/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention