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

Model Number ESS305

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Expulsion (2933); Material Integrity Problem (2978); Activation Failure (3270); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('with left sided device still some of the introducer present') and device expulsion ('left sided essure device identified within the uterine cavity') in a (b)(6) female patient who had essure (batch no.B06102 / a82453) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "left sided device clearly had not deployed properly at the time (of first insertion)" from (b)(6) 2013 to (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced device breakage (seriousness criterion medically significant) and complication of device insertion ("complication of device insertion").In 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain ("pain").The patient was treated with surgery (left sided essure coil removed from uterus on (b)(6) 2013, new left coil inserted successfully).On (b)(6) 2013, the device breakage, device expulsion and complication of device insertion had resolved.At the time of the report, the pelvic pain outcome was unknown.The reporter considered complication of device insertion, device breakage, device expulsion and pelvic pain to be related to essure.The reporter commented: as per initial report (medical records): the expelled left device was removed and another coil was inserted - it clearly had not deployed properly at the time and there was still some of the introducer present.The repeat procedure, however, was uneventful.Hysterosalpingogram to be repeated in 3 months.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2013: left sided essure device identified to be within the uterine cavity.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: information from duplicate case (b)(4) has been transferred to this present case, including reporter, essure insertion date and event pain.Two events extracted after review of initial case report and comment section: device breakage / complication of device insertion: "on removed left side essure coil still some of the introducer present".Start date of breakage and deployment issue was (b)(6) 2013 (date of device initial insertion).Reporter physician (medically confirmed) added from medical record.No new follow-up information was received from the reporter.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 ('with left sided device still some of the introducer present') and device expulsion ('left sided essure device identified within the uterine cavity') in a 40-year-old female patient who had essure (batch no.B06102 / a82453) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "left sided device clearly had not deployed properly at the time (of first insertion)" from (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced device breakage (seriousness criterion medically significant) and complication of device insertion ("complication of device insertion").In 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain ("pain").The patient was treated with surgery (left sided essure coil removed from uterus on (b)(6) 2013, new left coil inserted successfully).On (b)(6) 2013, the device breakage, device expulsion and complication of device insertion had resolved.At the time of the report, the pelvic pain outcome was unknown.The reporter considered complication of device insertion, device breakage, device expulsion and pelvic pain to be related to essure.The reporter commented: as per initial report (medical records): the expelled left device was removed and another coil was inserted - it clearly had not deployed properly at the time and there was still some of the introducer present.The repeat procedure, however, was uneventful.Hysterosalpingogram to be repeated in 3 months.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2013: left sided essure device identified to be within the uterine cavity.Quality-safety evaluation of ptc: unable to confirm complaint amendment: the report was amended for the following reason: information from duplicate case 2020-124282 has been transferred to this present case, including reporter, essure insertion date and event pain.Two events extracted after review of initial case report and comment section: device breakage / complication of device insertion: "on removed left side essure coil still some of the introducer present".Start date of breakage and deployment issue was (b)(6) 2013 (date of device initial insertion).Reporter physician (medically confirmed) added from medical record.No new follow-up information was received from the reporter.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 ('with left sided device still some of the introducer present') and device expulsion ('left sided essure device identified within the uterine cavity') in a 40-year-old female patient who had essure (batch no.B06102 , a82453) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "left sided device clearly had not deployed properly at the time (of first insertion)" from 1-mar-2013 to 21-nov-2013.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced device breakage (seriousness criterion medically significant) and complication of device insertion ("complication of device insertion").In 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain ("pain").The patient was treated with surgery (left sided essure coil removed from uterus on (b)(6) 2013, new left coil inserted successfully).On (b)(6) 2013, the device breakage, device expulsion and complication of device insertion had resolved.At the time of the report, the pelvic pain outcome was unknown.The reporter considered complication of device insertion, device breakage, device expulsion and pelvic pain to be related to essure.The reporter commented: as per initial report (medical records): the expelled left device was removed and another coil was inserted - it clearly had not deployed properly at the time and there was still some of the introducer present.The repeat procedure, however, was uneventful.Hysterosalpingogram to be repeated in 3 months.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2013: left sided essure device identified to be within the uterine cavity.Lot number: a82453.Manufacture date: 2012-12.Expiration date: 2015-12.Lot number: b06102.Manufacture date: 2013-03.Expiration date: 2016-03-31.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, 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 ('with left sided device still some of the introducer present'), device expulsion ('left sided essure device identified within the uterine cavity') and pelvic pain ('pain').In a 40-year-old female patient who had essure (batch no.B06102 , a82453) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "left sided device clearly had not deployed properly at the time (of first insertion)" from (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced device breakage (seriousness criterion medically significant) and complication of device insertion ("complication of device insertion").On 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("heavy/abnormal bleeding") and menstrual disorder ("changes in menstrual cycle").The patient was treated with surgery (hysterectomy on (b)(6) 2019, and left sided essure coil removed from uterus on (b)(6) 2013, new left coil inserted successfully).On (b)(6) 2013, the device breakage, device expulsion and complication of device insertion had resolved.At the time of the report, the pelvic pain, genital haemorrhage and menstrual disorder outcome was unknown.The reporter considered complication of device insertion, device breakage, device expulsion, genital haemorrhage, menstrual disorder and pelvic pain to be related to essure.The reporter commented: as per initial report (medical records): the expelled left device was removed and another coil was inserted.It clearly had not deployed properly at the time, and there was still some of the introducer present.The repeat procedure however, was uneventful.Hysterosalpingogram to be repeated in (b)(6) months.According to follow-up: some symptoms/events are still ongoing.Not clear which of them.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on 2013, left sided essure device identified to be within the uterine cavity.Lot number#: a82453, manufacture date: 2012-12, expiration date: 2015-12; lot number#: b06102, manufacture date: 2013-03, expiration date: 2016-03-31.Quality safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2021, quality-safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted.Including a batch review and review of complaint records and records of non-conformances data.Should any new and reportable information become available as a result, 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 ('with left sided device still some of the introducer present'), device expulsion ('left sided essure device identified within the uterine cavity') and pelvic pain ('pain') in a 40-year-old female patient who had essure (batch no.B06102 , a82453) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "left sided device clearly had not deployed properly at the time (of first insertion)" from (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced device breakage (seriousness criterion medically significant) and complication of device insertion ("complication of device insertion").In 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("heavy/abnormal bleeding") and menstrual disorder ("changes in menstrual cycle").The patient was treated with surgery (hysterectomy on (b)(6) 2019 and left sided essure coil removed from uterus on (b)(6) 2013, new left coil inserted successfully).On (b)(6) 2013, the device breakage, device expulsion and complication of device insertion had resolved.At the time of the report, the pelvic pain, genital haemorrhage and menstrual disorder outcome was unknown.The reporter considered complication of device insertion, device breakage, device expulsion, genital haemorrhage, menstrual disorder and pelvic pain to be related to essure.The reporter commented: as per initial report (medical records): the expelled left device was removed and another coil was inserted - it clearly had not deployed properly at the time and there was still some of the introducer present.The repeat procedure, however, was uneventful.Hysterosalpingogram to be repeated in 3 months.According to follow-up, some symptoms/events are still ongoing, not clear which of them.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2013: left sided essure device identified to be within the uterine cavity.Lot number: a82453, manufacture date: 2012-12, expiration date: 2015-12.Lot number: b06102, manufacture date: 2013-03, expiration date: 2016-03-31.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021: essure removal date added; event "pelvic pain female" upgraded as removal by hysterctomy was informed; events added "changes in menstrual cycle" and "heavy/abnormal bleeding." we received a lot number in this case.A technical investigation was conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, 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: 10229766
• MDR Text Key: 201273274
• Report Number: 2951250-2020-10381
• 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,foreign,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: ESS305
• Device Lot Number: B06102 , A82453
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR