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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Pain (1994); Thrombosis (2100); Tinnitus (2103); Discomfort (2330); Heavier Menses (2666)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 25-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("increasingly heavy menstruations / menstruations more and more abundant"), deep vein thrombosis ("suspected thrombosis") and fatigue ("general fatigue") in a (b)(6) female patient who had essure (batch no.D40631) inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included depression.On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2016, the patient experienced fatigue (seriousness criterion hospitalization).On an unknown date, the patient experienced menorrhagia (seriousness criterion medically significant), deep vein thrombosis (seriousness criterion medically significant), tinnitus ("tinnitus"), limb discomfort ("heavy legs") and pain in extremity ("painful legs").The patient was treated with piribedil (trivastal).At the time of the report, the menorrhagia, deep vein thrombosis, fatigue, tinnitus, limb discomfort and pain in extremity outcome was unknown.The reporter provided no causality assessment for deep vein thrombosis, fatigue, limb discomfort, menorrhagia, pain in extremity and tinnitus with essure.The reporter commented: the patient was fine from depression since several months.Two unspecified medications were prescribed due to abundant menstruations.Additional visit was planned with another gynecologist on (b)(6).Ent (ears, nose, and throat) visit due to tinnitus.Diagnostic results (normal ranges are provided in parenthesis if available): (b)(6).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.In this particular case a search in the database was performed on 28-aug-2017 for the following meddra preferred term: menorrhagia.The analysis in the global safety database revealed 461 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.Company causality comment: incident.At the time of reporting, 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 case was initially received via regulatory authority (b)(6) (reference number: (b)(4) on 25-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("increasingly heavy menstruations/menstruations more and more abundant"), deep vein thrombosis ("suspected thrombosis") and fatigue ("general fatigue") in a (b)(6) female patient who had essure (batch no.D40631) inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included depression.On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2016, the patient experienced fatigue (seriousness criterion hospitalization).On an unknown date, the patient experienced menorrhagia (seriousness criterion medically significant), deep vein thrombosis (seriousness criterion medically significant), tinnitus ("tinnitus"), limb discomfort ("heavy legs") and pain in extremity ("painful legs").The patient was treated with piribedil (trivastal).At the time of the report, the menorrhagia, deep vein thrombosis, fatigue, tinnitus, limb discomfort and pain in extremity outcome was unknown.The reporter provided no causality assessment for deep vein thrombosis, fatigue, limb discomfort, menorrhagia, pain in extremity and tinnitus with essure.The reporter commented: the patient was fine from depression since several months.Two unspecified medications were prescribed due to abundant menstruations.Additional visit was planned with another gynecologist on (b)(6).Ent (ears, nose, and throat) visit due to tinnitus.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-sep-2017: quality safety evaluation of ptc.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.In this particular case a search in the database was performed on 29-sep-2017 for the following meddra preferred term: menorrhagia.The analysis in the global safety database revealed 492cases.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.At the time of reporting, 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 07981-0915
• MDR Report Key: 6858768
• MDR Text Key: 85809090
• Report Number: 2951250-2017-03578
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: ESS305
• Device Lot Number: D40631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2014
• 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): Hospitalization; Other
• Patient Age: 45 YR
• Patient Weight: 69