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

Model Number ESS305

Device Problem Device Inoperable (1663)

Patient Problem Ectopic Pregnancy (1819)

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of ectopic pregnancy with contraceptive device ("ectopic pregnancy while still on essure") in an adult female patient who had essure inserted for sterilisation.Other product or product use issues identified: device ineffective "device ineffective".On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.At the time of the report, the ectopic pregnancy with contraceptive device outcome was unknown.The reporter considered ectopic pregnancy with contraceptive device to be related to essure.The reporter commented: a left salpingectomy was performed on (b)(6) 2013.She reported another pregnancy case while essure.Essure was explanted in 2013 (see case# 2016-087447).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2009: total bilateral occlusion.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: 7439622
• MDR Text Key: 105797333
• Report Number: 2951250-2018-01872
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• 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
• Date Manufacturer Received: 02/28/2018
• 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