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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Material Perforation (2205); Component Missing (2306)

Patient Problems Rheumatoid Arthritis (1724); Hair Loss (1877); Perforation (2001); Arthralgia (2355); Depression (2361); Numbness (2415); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Pregnancy (3193)

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("displaced essure"), uterine perforation ("x-rays actually showed the missing essure device inside of the uterus/ the uterus had also been perforated"), fallopian tube perforation ("postoperatively,one of the fallopian tubes was found to have been perforated / had migrated and could not be located/ x-rays showed a metallic foreign body in the area of pelvis") and pregnancy with contraceptive device ("pregnant") in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's past medical history included parity in (b)(6) 2011.In (b)(6) 2011, the patient had essure inserted.In (b)(6) 2012, the patient experienced rheumatoid arthritis ("rheumatoid arthritis") with arthralgia, myalgia, bone pain, joint stiffness, joint swelling and arthralgia.In (b)(6) 2014, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion medically significant), menorrhagia ("prolonged abnormally heavy menstrual bleeding"), menstrual disorder ("abnormal menstruation"), fatigue ("chronic fatigue"), weight increased ("weight gain"), depression ("depression"), alopecia ("hair loss"), dyspareunia ("painful intercourse"), abdominal distension ("abdominal distention/ swelling"), pain ("general body aches"), malaise ("general malaise"), back pain ("back pain"), asthenia ("weakness") and hypoaesthesia ("numbness in both feet").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with etanercept (enbrel), surgery (bilateral salpingectomy) and surgery (total hysterectomy in (b)(6) 2015).Essure was removed in (b)(6) 2015.On (b)(6) 2015, the pregnancy with contraceptive device had resolved.At the time of the report, the device dislocation and uterine perforation had resolved, the fallopian tube perforation, menorrhagia, menstrual disorder, fatigue, weight increased, depression, alopecia, dyspareunia, abdominal distension, pain and malaise outcome was unknown and the rheumatoid arthritis, back pain, asthenia and hypoaesthesia had not resolved.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2015.The reporter considered abdominal distension, alopecia, asthenia, back pain, depression, device dislocation, dyspareunia, fallopian tube perforation, fatigue, hypoaesthesia, malaise, menorrhagia, menstrual disorder, pain, pregnancy with contraceptive device, rheumatoid arthritis, uterine perforation and weight increased to be related to essure.The reporter commented: in (b)(6) of 2014, she was preparing for surgery to remove her gallbladder as a result of an attack she had the prior month.As part of her pre-surgical testing for this surgery, she had to have blood drawn.Much to her shock and dismay, the results of her bloodwork revealed that she was pregnant.In (b)(6) 2015, it was discovered that one of the fallopian tubes was found to have been perforated and that the essure that was supposed to be therein, had migrated and could not be located.Within a few weeks of having her fallopian tubes removed, she started having increased abdominal and pelvic cramping.X-rays showed a metallic foreign body in the area of pélvis; device inside of the uterus.Hysterectomy was done and after surgery, the missing essure micro-insert was found within the uterus and upon further examination of the uterus, it was discovered that the uterus had also been perforated.Only some of the symptoms have resolved since her removal surgeries.Diagnostic results (normal ranges are provided in parenthesis if available): blood test - in (b)(6) 2014: pregnancy positive hysterosalpingogram - in (b)(6) 2012: confirming full occlusion of tubes ultrasound scan - in (b)(6) 2014: 6 weeks pregnant (pregnancy was not ectopic) x-ray - on an unknown date: metallic foreign body in the area of pelvis; on an unknown date: device inside of the uterus.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: 6999983
• MDR Text Key: 91066352
• Report Number: 2951250-2017-06011
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• 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: 09/25/2017
• 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