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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("one essure device was embedded in uterus and could not be safely removed") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain and complication of device removal ("one essure device was embedded in uterus and could not be safely removed").The patient was treated with surgery (bilateral salpingectomy to remove essure in (b)(6) 2016, hysterectomy to remove the embedded device).Essure was removed in (b)(6) 2016.At the time of the report, the embedded device and complication of device removal outcome was unknown.The reporter considered complication of device removal and embedded device to be related to essure.The reporter commented: patient presented to the accident and emergency department in (b)(6) with significant pain.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 (pt).In this particular case a search in the global safety database was performed on (b)(6) 2017 for the following meddra pt: embedded device: the analysis revealed 422 cases (excluding this case).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 this meddra pt.Incident.No lot number or sample was 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 in a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("one essure device was embedded in uterus and could not be safely removed"), device breakage ("a part of one of the springs broken off (during removal procedure)") and rectal haemorrhage ("rectal bleeding") in a 34-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included sleep disturbance.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain and complication of device removal ("one essure device broken off and was embedded in uterus and could not be safely removed").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("vaginal bleeding"), rectal haemorrhage (seriousness criterion medically significant), vaginal disorder ("vaginal dysfunction"), functional gastrointestinal disorder ("rectal dysfunction"), abdominal pain ("severe abdominal pain "), abdominal tenderness ("abdominal tenderness"), pollakiuria ("increased urinary frequency"), micturition urgency ("increased urinary urgency"), stress urinary incontinence ("stress incontinence"), depressed mood ("low mood "), anxiety ("anxiety ") and sleep disorder ("exacerbation of sleep disturbance").The patient was treated with surgery (bilateral salpingectomy to remove essure in (b)(6) 2016, hysterectomy to remove the embedded device and hysterectomy performed on (b)(6) (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the embedded device, complication of device removal, vaginal haemorrhage, rectal haemorrhage, vaginal disorder, functional gastrointestinal disorder, abdominal pain, abdominal tenderness, pollakiuria, micturition urgency, stress urinary incontinence, depressed mood, anxiety and sleep disorder outcome was unknown.The reporter considered abdominal pain, abdominal tenderness, anxiety, complication of device removal, depressed mood, device breakage, embedded device, functional gastrointestinal disorder, micturition urgency, pollakiuria, rectal haemorrhage, sleep disorder, stress urinary incontinence, vaginal disorder and vaginal haemorrhage to be related to essure.The reporter commented: patient presented to the accident and emergency department in (b)(6) 2014 with significant pain.The removal procedure was not a success.It was not possible to remove all the essure devices.A part of one of the springs broken off and embedded into patient`s uterus.She was discharged home after the procedure in agony.Hysterectomy performed on (b)(6) 2017 to retrieve the remaining parts of essure.Diagnostic results (normal ranges are provided in parenthesis if available): scan - in 2015: one of the essure springs was not where it meant to be.X-ray - in 2014: nothing abnormal was detected.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 (pt).In this particular case a search in the global safety database was performed on (b)(6) 2018 for the following meddra pt: embedded device: 900 cases device breakage: 3001 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 this meddra pt.Most recent follow-up information incorporated above includes: on (b)(6) 2018: statement of claim received.Information added: events (vaginal bleeding, rectal bleeding, vaginal dysfunction, dysfunction, severe abdominal pain, abdominal tenderness, increased urinary frequency, increased urinary urgency, stress incontinence, low mood, anxiety, exacerbation of sleep disturbance, a part of one of the springs broken off (during removal procedure); medical history, lab tests, removal process details.Incident no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7114473
• MDR Text Key: 94751346
• Report Number: 2951250-2017-10722
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2018

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: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 11/30/2018; 12/14/2018
• Supplement Dates FDA Received: 12/04/2018; 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR