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

Model Number ESS305

Device Problems Break (1069); Sticking (1597)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/24/2016

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 31-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("essure and the fallopian tubes were removed"), embedded device ("essure was stuck on right side during removal causing a bleeding") and procedural haemorrhage ("essure was stuck on right side during removal causing a bleeding") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2011, the patient had essure inserted.On (b)(6) 2016, the patient underwent medical device removal (seriousness criteria medically significant and intervention required), procedural haemorrhage (seriousness criterion medically significant), device breakage ("fragments were left behind") and complication of device removal ("fragments were left behind").On (b)(6) 2016, the patient experienced medical device removal (seriousness criteria medically significant and intervention required), procedural haemorrhage (seriousness criterion medically significant), device breakage ("fragments were left behind") and complication of device removal ("fragments were left behind").On an unknown date, the patient experienced embedded device (seriousness criterion medically significant), musculoskeletal pain ("pain in neck, joints and back") and fatigue ("fatigue").The patient was treated with surgery.At the time of the report, the medical device removal, embedded device, procedural haemorrhage, device breakage, complication of device removal, musculoskeletal pain and fatigue had not resolved.The reporter provided no causality assessment for complication of device removal, device breakage, embedded device, fatigue, medical device removal, musculoskeletal pain and procedural haemorrhage with essure.The reporter commented: essure could not be completely removed, and fragments remained in situ.Therefore, patient is not yet complaint free.If patient wants to get rid of all complaints, the entire uterus must be removed.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 04-sep-2017 for the following meddra preferred terms: medical device removal.The analysis in the global safety database revealed 722 cases.Embedded device.The analysis in the global safety database revealed 369 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 these meddra pts.Further company follow-up with the regulatory authority is not possible.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 07981-0915
• MDR Report Key: 6894320
• MDR Text Key: 87383702
• Report Number: 2951250-2017-03983
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• 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: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 39 YR