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

Model Number ESS305

Device Problems Break (1069); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracture') and device dislocation ('migration') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding") and mental disorder ("psych injury").The patient was treated with surgery (salpingectomy- bilateral).Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, device dislocation and mental disorder outcome was unknown and the pelvic pain and genital haemorrhage had resolved.The reporter considered device breakage, device dislocation, genital haemorrhage, mental disorder and pelvic pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2013: results: not provided.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 09-jan-2020: pif received.Event injury updated to device breakage.New event added: pelvic pain, abnormal bleeding, psych injury and migration.Essure removal date added.Case upgraded to serious incident.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracture') and device dislocation ('migration') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding") and mental disorder ("psych injury").The patient was treated with surgery (salpingectomy- bilateral).Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, device dislocation and mental disorder outcome was unknown and the pelvic pain and genital haemorrhage had resolved.The reporter considered device breakage, device dislocation, genital haemorrhage, mental disorder and pelvic pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2013: results-not provided.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-jun-2020: quality safety evaluation of ptc based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracture/the proximal end of the left micro-insert appears') and device expulsion ('migration/essure device apparently sitting in the fundus of the uterus') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included dizziness, left lower quadrant pain, dysfunctional uterine bleeding and headache.Previously administered products included for an unreported indication: mirena.Concomitant products included ethinylestradiol;norethisterone acetate (microgestin).On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding") and mental disorder ("psych injury").The patient was treated with surgery (salpingectomy- bilateral).Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, device expulsion and mental disorder outcome was unknown and the pelvic pain and genital haemorrhage had resolved.The reporter considered device breakage, device expulsion, genital haemorrhage, mental disorder and pelvic pain to be related to essure.The reporter commented: discrepancy noted in insertion details : as per mr, (b)(6) 2012 and (b)(6) 2012.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: status post essure procedure as detailed above.The right micro-insert is extra-tubal with patent right fallopian tube 1.Hysteroscopy and removal of essure from the uterine fundus.2.Bilateral laparoscopic salpingectomies.The left tube was removed with the essure device in situ.Imaging procedure - on (b)(6) 2013: results-not provided.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s media records: device dislocation, device breakage.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-may-2021: mr received.Reporter information , date of birth , other relevant history, lab data , concomitant drug added and rcc was updated.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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: 10133009
• MDR Text Key: 194484250
• Report Number: 2951250-2020-08498
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICROGESTIN.
• Patient Outcome(s): Other; Required Intervention