MAUDE Adverse Event Report: BAYER ESSURE

Lot Number 872991

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Failure of Implant (1924); Pregnancy (3193)

Event Date 08/03/2016

Event Type  Injury  

Event Description

I had the essure procedure done in (b)(6) 2011, and went through the dye testing and was told that both tubes were blocked.I just found out on (b)(6) 2016 (almost 5 years later and currently (b)(6) old) that i am pregnant and the fetus is growing in the uterus and not an (b)(6) pregnancy.The ultrasound tech can see both essure devices in place and they are protruding out the top of the fallopian tubes.My doctor is concerned how this will go as the baby grows and how sharp/strong the essure is (possibly can puncture the amniotic sack).I chose to have this procedure because i was lucky to have had two healthy children already and have serious complications during pregnancy and child birth; at this time i am considered high risk by my doctor and will most likely have to stop working to continue this pregnancy.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5955782
• MDR Text Key: 55036425
• Report Number: MW5064791
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/14/2016

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: Lay User/Patient
• Device Lot Number: 872991
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 44