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

Model Number ESS205

Device Problems Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracture') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2007, the patient had essure (ess205) inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding"), menorrhagia ("menorrhagia"), anaemia ("anaemia"), psychological trauma ("psych injury"), urinary tract infection ("uti"), fatigue ("fatigue") and post procedural complication ("post removal complication").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure (ess205) was removed on (b)(6) 2018.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, menorrhagia, anaemia, urinary tract infection and fatigue had resolved and the psychological trauma and post procedural complication outcome was unknown.The reporter considered anaemia, device breakage, fatigue, genital haemorrhage, menorrhagia, pelvic pain, post procedural complication, psychological trauma and urinary tract infection to be related to essure (ess205).The reporter commented: discrepancy noted insertion date (b)(6) 2007.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-may-2020: pfs received-previously reported event injury nos was replaced with pelvic pain, abnormal bleeding, fracture, menorrhagia, anemia, uti, fatigue, post removal complication.On 9-jan-2020: pfs received -no new information.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') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2007, the patient had essure (ess205) inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding"), menorrhagia ("menorrhagia"), iron deficiency anaemia ("anaemia"), psychological trauma ("psych injury"), urinary tract infection ("uti"), fatigue ("fatigue") and post procedural complication ("post removal complication").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure (ess205) was removed on (b)(6) 2018.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, menorrhagia, iron deficiency anaemia, urinary tract infection and fatigue had resolved and the psychological trauma and post procedural complication outcome was unknown.The reporter considered device breakage, fatigue, genital haemorrhage, iron deficiency anaemia, menorrhagia, pelvic pain, post procedural complication, psychological trauma and urinary tract infection to be related to essure (ess205).The reporter commented: discrepancy noted insertion date (b)(6) 2007 quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-may-2020: quality-safety evaluation of product technical complaint.Event anemia updated to anemia from chronic blood loss.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 right coil is fractured between the proximal end of the inner coil') in an adult female patient who had essure (ess205) (batch no.621684) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiparous.Concurrent conditions included muscular weakness, neck pain, glucose tolerance impaired, hypochromic microcytic anemia, vitamin d low, menstrual flow excessive, cervicitis, vaginal bleeding, cervical cyst, rash (nonspecific), skin eruption, leiomyoma of uterus, unspecified, abnormal uterine bleeding, female pelvic peritoneal adhesions, unspecified inflammatory disease of uterus, excl cervix, anemia, unspecified, paratubal cyst, uterine enlargement and endometriosis.On (b)(4) 2007, the patient had essure (ess205) inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding"), heavy menstrual bleeding ("menorrhagia"), iron deficiency anaemia ("anaemia"), psychological trauma ("psych injury"), urinary tract infection ("uti"), fatigue ("fatigue") and post procedural complication ("post removal complication").The patient was treated with surgery (hysterectomy with bilateral salpingectomy, bilateral salpingo-oophorectomy).Essure (ess205) was removed on (b)(4) 2018.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, heavy menstrual bleeding, iron deficiency anaemia, urinary tract infection and fatigue had resolved and the psychological trauma and post procedural complication outcome was unknown.The reporter considered device breakage, fatigue, genital haemorrhage, heavy menstrual bleeding, iron deficiency anaemia, pelvic pain, post procedural complication, psychological trauma and urinary tract infection to be related to essure (ess205).The reporter commented: discrepancy noted insertion date 30-apr-2007 bilateral ostia seen on the left the essure had 5 coils seen out of the ostium, and on the right, there were 2 coils seen out of the ostia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on 30-apr-2007: 1.Bilateral fallopian tubal occlusion is demonstrated 2.On the right, contrast enters the most proximal aspect of the right tube to the level of the proximal outer coil.The right-sided coil is fractured between the proximal inner coil and the proximal outer coil.The proximal inner coil is within 3 cm of the level of tubal occlusion at the proximal outer coil.3.On the left, minimal proximal left tubal filling to the level of the proximal inner coil.4.Otherwise unremarkable postoperative hysterosalpingogram.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: fatigue, heavy menstrual bleeding, device breakage quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 21-apr-2021: mr received.Reporter information, patient's medical history, lab data, lot number and rcc were added.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this 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 right coil is fractured between the proximal end of the inner coil') in an adult female patient who had essure (ess205) (batch no.621684) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiparous.Concurrent conditions included muscular weakness, neck pain, glucose tolerance impaired, hypochromic microcytic anemia, vitamin d low, menstrual flow excessive, cervicitis, vaginal bleeding, cervical cyst, rash (nonspecific), skin eruption, leiomyoma of uterus, unspecified, abnormal uterine bleeding, female pelvic peritoneal adhesions, cervix inflammation, anemia, unspecified, paratubal cyst, uterine enlargement and endometriosis.On (b)(6) 2007, the patient had essure (ess205) inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding"), heavy menstrual bleeding ("menorrhagia"), iron deficiency anaemia ("anaemia"), psychological trauma ("psych injury"), urinary tract infection ("uti"), fatigue ("fatigue") and post procedural complication ("post removal complication").The patient was treated with surgery (hysterectomy with bilateral salpingectomy, bilateral salpingo-oophorectomy).Essure (ess205) was removed on (b)(6) 2018.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, heavy menstrual bleeding, iron deficiency anaemia, urinary tract infection and fatigue had resolved and the psychological trauma and post procedural complication outcome was unknown.The reporter considered device breakage, fatigue, genital haemorrhage, heavy menstrual bleeding, iron deficiency anaemia, pelvic pain, post procedural complication, psychological trauma and urinary tract infection to be related to essure (ess205).The reporter commented: discrepancy noted insertion date (b)(6) 2007.Bilateral ostia seen on the left the essure had 5 coils seen out of the ostium, and on the right, there were 2 coils seen out of the ostia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: 1.Bilateral fallopian tubal occlusion is demonstrated 2.On the right, contrast enters the most proximal aspect of the right tube to the level of the proximal outer coil.The right-sided coil is fractured between the proximal inner coil and the proximal outer coil.The proximal inner coil is within 3 cm of the level of tubal occlusion at the proximal outer coil.3.On the left, minimal proximal left tubal filling to the level of the proximal inner coil.4.Otherwise unremarkable postoperative hysterosalpingogram.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: fatigue, heavy menstrual bleeding, device breakage lot number: 621684 manufacturing date: 2006-11 expiration date: 2008-10.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 6-may-2021: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant 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: 10082030
• MDR Text Key: 191824351
• Report Number: 2951250-2020-08055
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2008
• Device Model Number: ESS205
• Device Lot Number: 621684
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention