MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problems Death (1802); Ectopic Pregnancy (1819); Headache (1880); Menstrual Irregularities (1959); Vomiting (2144); Dizziness (2194); Pregnancy (3193)

Event Date 01/04/2010

Event Type  Death  

Event Description

(b)(4).I had the essure device placed in (b)(6) 2007.I had the hsg done 8 weeks later and it confirmed that both fallopian tubes were occluded.Afterwards my periods became irregular.I was told by my doctor that they were irregular because of my weight and i was diagnosed with pre-diabetes.I was told to lose weight and then my cycle would regulate itself.In (b)(6) of 2010 i suffered a dizzy spell, with vomiting and headaches.Upon being admitted to the er i was diagnosed with vertigo.During that visit they wanted to do an mri but i refused it because none of the doctors or nurses could explain how the electromagnetic field would effect the essure coils.(b)(6) of 2011 i found out i was pregnant with my third child.The doctor that i was seeing was not trained to perform the essure procedure so she went to a conference and spoke with some essure sales representatives.My son died as a result of her lack of knowledge at (b)(6).After the pregnancy my periods continued to be irregular.The would last about 30-35 days every other month.A new doctor then diagnosed me with uterine polyps and a surgery was scheduled to remove them.During the surgery it was found that the essure coils had migrated out of my fallopian tubes and were now lodged in my uterus.The visible coils were removed, there is still one of the coils left lodged in the left wall of my uterus.(b)(6) of 2014 i was admitted to the er and diagnosed with and ectopic pregnancy.Surgery was performed and half of my left ovary was removed, both fallopian tubes remained in tack and open.(b)(6) of 2015 i became pregnant again.I am currently (b)(6).

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5107430
• MDR Text Key: 26883062
• Report Number: MW5056532
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 37.000 YR