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 Problem Injury (2348)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("xenobiotic material removed") in a (b)(6) female patient who had essure inserted for female sterilization.On (b)(6) 2016, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery.Essure was removed.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.The reporter commented: because of the complaints she is being impeded in her normal daily functioning and is suffering from injury.The patient holds the company liable for the damage caused.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) 2017 for the following meddra preferred term: medical device removal.The analysis in the global safety database revealed (b)(4) 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 this meddra pt.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 consumer and describes the occurrence of medical device removal ("xenobiotic material removed") in a (b)(6) year-old female patient who had essure inserted for female sterilization.On (b)(6) 2016, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery.Essure was removed.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.The reporter commented: because of the complaints she is being impeded in her normal daily functioning and is suffering from injury.The patient holds the company liable for the damage caused.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 05-jan-2018 for the following meddra preferred term: medical device removal.The analysis in the global safety database revealed 727 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 this meddra pt.Most recent follow-up information incorporated above includes: on 21-dec-2017: after a company internal review the similar incident listing count was updated.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 consumer and describes the occurrence of abdominal pain ("abdominal pain") in a 45-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2016, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), menstruation irregular ("often bleedings and intermediate / irregular menstruation") and headache ("headache").In (b)(6) 2017, the patient experienced mental disorder ("psychological complaints"), asthenia ("cannot stand for long"), aggression ("aggressive") and depression ("depression").In (b)(6) 2017, the patient experienced arthralgia ("hip complaints during walking / hip pain").The patient was treated with surgery (essure implant removal).Essure was removed on (b)(6) 2017.In (b)(6) 2017, the abdominal pain and menstruation irregular had resolved with sequelae.In (b)(6) 2017, the mental disorder and depression had resolved with sequelae.In (b)(6) 2018, the aggression had resolved with sequelae.In (b)(6) 2018, the asthenia and headache had resolved with sequelae.In (b)(6) 2018, the arthralgia had resolved with sequelae.The reporter considered abdominal pain, aggression, arthralgia, asthenia, depression, headache, menstruation irregular and mental disorder to be related to essure.The reporter commented: because of the complaints she is being impeded in her normal daily functioning and is suffering from injury.The patient holds the company liable for the damage caused.She was not hospitalized and did not receive any treatment.She has not used essure before.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 term: abdominal pain.The analysis in the global safety database revealed 2174 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 this meddra pt.Most recent follow-up information incorporated above includes: on (b)(6) 2018: xenobiotic material removed was deleted as event and psychological complaints, depression, hip complaints during walking, often bleedings and intermediate, cannot stand for long, aggressive, a lot of abdominal pain, a lot of headache, were added; outcome recovered with sequelae, namely: once in a while hip pain, headache, irregular menstruation; essure stop date (b)(6) 2017.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: 7147482
• MDR Text Key: 95811517
• Report Number: 2951250-2017-11141
• 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,Followup
• Report Date: 05/08/2018

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: 12/21/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 12/21/2017; 05/07/2018
• Supplement Dates FDA Received: 01/05/2018; 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR