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

Model Number ESS305

Device Problems Break (1069); Patient-Device Incompatibility (2682); Material Integrity Problem (2978); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Fallopian Tube Perforation (4506); Menorrhagia (4508); Insufficient Information (4580)

Event Date 03/08/2017

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage / left essure was found in multiple pieces') and fallopian tube perforation ('perforation (fallopian tube(s)') in a female patient who had essure inserted for female sterilization.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), fallopian tube perforation (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea (cramping)"), alopecia ("hair loss"), pelvic pain ("pelvic pain") and abdominal pain ("abdominal pain").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on(b)(6) 2019.At the time of the report, the device breakage, fallopian tube perforation, vaginal haemorrhage, menorrhagia, dysmenorrhoea, alopecia, pelvic pain and abdominal pain outcome was unknown.The reporter considered abdominal pain, alopecia, device breakage, dysmenorrhoea, fallopian tube perforation, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: essure confirmation test(s) conducted: yes.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram on (b)(6) 2012: fallopian tube patency.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-mar-2020: pfs received: event injury replaced by: abnormal bleeding (vaginal, menorrhagia), salpingectomy (bilateral) were added.Reporter, demographics were added.On 31-mar-2020: mr received: reporters, lab data were added.Fu 2 and 3 processed together.Based on the available information, a review of our complaint records and other relevant data will be 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 ('device breakage / left essure was found in multiple pieces') and fallopian tube perforation ('perforation (fallopian tube(s)') in a female patient who had essure inserted for female sterilization.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), fallopian tube perforation (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea (cramping)"), alopecia ("hair loss"), pelvic pain ("pelvic pain") and abdominal pain ("abdominal pain").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6)2019.At the time of the report, the device breakage, fallopian tube perforation, vaginal haemorrhage, menorrhagia, dysmenorrhoea, alopecia, pelvic pain and abdominal pain outcome was unknown.The reporter considered abdominal pain, alopecia, device breakage, dysmenorrhoea, fallopian tube perforation, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: essure confirmation test(s) conducted: yes.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: fallopian tube patency.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-may-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data will be 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 ('device breakage / left essure was found in multiple pieces'), fallopian tube perforation ('perforation (fallopian tube(s))') and device dislocation ('migration of essure device') in a 42-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Concomitant products included cetirizine hydrochloride (cetrizine) and colecalciferol (vitamin d3).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2017, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("menorrhagia"), 5 years 2 months after insertion of essure.In (b)(6) 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pelvic pain").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), alopecia ("hair loss"), abdominal pain ("abdominal pain") and abdominal pain lower ("lower abdomnal pain").The patient was treated with surgery (bilateral salpingectomy and hysteroscopy/ bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, fallopian tube perforation, device dislocation, dysmenorrhoea, alopecia, pelvic pain and abdominal pain outcome was unknown and the vaginal haemorrhage, menorrhagia and abdominal pain lower had resolved.The reporter considered abdominal pain, abdominal pain lower, alopecia, device breakage, device dislocation, dysmenorrhoea, fallopian tube perforation, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: essure confirmation test(s) conducted: yes.Discrepancy noted: date(s) of insertion: (b)(6) 2012.Date(s) of removal: (b)(6) 2018, (b)(6) 2019(bilateral salpingectomy).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: results: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-jun-2020: pfs received : events added- lower abdominal pain, migration of essure device.Reporter added, patient demographics added.Events outcome updated of events lower abdominal pain.Menorrhagia, vaginal haemorrhage.Based on the available information, a review of our complaint records and other relevant data will be 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 ('device breakage / left essure was found in multiple pieces'), fallopian tube perforation ('perforation (fallopian tube(s))'), device dislocation ('migration of essure device') and heavy menstrual bleeding ('menorrhagia') in a 42-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Concomitant products included cetirizine hydrochloride (cetrizine) and colecalciferol (vitamin d3).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2017, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and heavy menstrual bleeding (seriousness criteria medically significant and intervention required), 5 years 2 months after insertion of essure.In (b)(6) 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pelvic pain").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), alopecia ("hair loss"), abdominal pain ("abdominal pain") and abdominal pain lower ("lower abdomnal pain").The patient was treated with surgery (bilateral salpingectomy, bilateral salpingectomy , ablation, d&c.And hysteroscopy/ bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, fallopian tube perforation, device dislocation, dysmenorrhoea, alopecia, pelvic pain and abdominal pain outcome was unknown and the vaginal haemorrhage, heavy menstrual bleeding and abdominal pain lower had resolved.The reporter considered abdominal pain, abdominal pain lower, alopecia, device breakage, device dislocation, dysmenorrhoea, fallopian tube perforation, heavy menstrual bleeding, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: essure confirmation test(s) conducted: yes.Discrepancy noted: date(s) of insertion: (b)(6) 2012.Date(s) of removal: (b)(6) 2018, (b)(6) 2019 (bilateral salpingectomy).As per pfs: current weight 194 lbs.Approximate weight at the time of essure placement 180 lbs.As per pif, discrepancy noted in date of insertion: (b)(6) 2012.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: results: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-apr-2021: pif received.Rcc was added.Based on the available information, a review of our complaint records and other relevant data will be 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: 10011391
• MDR Text Key: 189749133
• Report Number: 2951250-2020-06162
• 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,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• 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: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CETRIZINE; CETRIZINE; VITAMIN D3; VITAMIN D3
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR