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

Model Number ESS305

Device Problems Break (1069); Separation Failure (2547); Insufficient Information (3190)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil') and pelvic pain ('physical pain/pelvic area pain mild to severe') in an adult female patient who had essure (batch no.B94868) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included vulval itching.Concomitant products included atorvastatin since 2016, glimepiride since 2016, hydrochlorothiazide since 2016, levothyroxine and metformin since 2016.In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2015, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: depression") and dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil").The patient was treated with surgery (laparoscopic bilateral salpingectomy, laparoscopic removal of right essure coil and salpingectomy (bilateral removal of fallopian tube), removal of right essure coil).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, complication of device removal, vaginal haemorrhage, menorrhagia, depression, anxiety and dysmenorrhoea outcome was unknown and the pelvic pain was resolving.The reporter considered anxiety, complication of device removal, depression, device breakage, dysmenorrhoea, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: per insertion details: however, it did not release correctly.Part of the essure was in the fallopian lumen; however, part of it was still left in the apparatus.The apparatus was removed, and then physician attempted to grasp the coil with the hysteroscopic grasper.Multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil, so the essure procedure was halted.Discrepancy noted: in current f/up it was mentioned that she didn¿t undergo an essure confirmation test, but previously hysterosalpingogram was reported with result.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: result: essure device was successfully occluded.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 19-jun-2019: pfs and mr received.Events per pfs: abnormal bleeding (vaginal, menorrhagia), psychological or psychiatric problems condition: depression & mental anguish, dysmenorrhea (cramping) were added.Event from mr: multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil (device breakage and incomplete device removal) was added.Essure removal procedure and date were received.Lot number added, patient's medical history was added.Lot number added.Concomitant medications were added.Incident: 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 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 ('multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil') and pelvic pain ('physical pain/pelvic area pain mild to severe') in an adult female patient who had essure (batch no.B94868) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included vulval itching.Concomitant products included atorvastatin since 2016, glimepiride since 2016, hydrochlorothiazide since 2016, levothyroxine and metformin since 2016.In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2015, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish") and dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil").The patient was treated with surgery (laparoscopic bilateral salpingectomy, laparoscopic removal of right essure coil and salpingectomy (bilateral removal of fallopian tube), removal of right essure coil).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, complication of device removal, vaginal haemorrhage, menorrhagia, depression, anxiety and dysmenorrhoea outcome was unknown and the pelvic pain was resolving.The reporter considered anxiety, complication of device removal, depression, device breakage, dysmenorrhoea, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: per insertion details: however, it did not release correctly.Part of the essure was in the fallopian lumen; however, part of it was still left in the apparatus.The apparatus was removed, and then physician attempted to grasp the coil with the hysteroscopic grasper.Multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil, so the essure procedure was halted.Discrepancy noted: in current f/up it was mentioned that she didn¿t undergo an essure confirmation test, but previously hysterosalpingogram was reported with result.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: result: essure device was successfully occluded.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-jun-2019: quality safety evaluation of ptc.Incident 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 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 ('multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil') and pelvic pain ('physical pain/pelvic area pain mild to severe') in an adult female patient who had essure (batch no.B94868) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included vulval itching.Concomitant products included atorvastatin since 2016, glimepiride since 2016, hydrochlorothiazide since 2016, levothyroxine and metformin since 2016.In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2015, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish") and dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil").The patient was treated with surgery (laparoscopic bilateral salpingectomy, laparoscopic removal of right essure coil and salpingectomy (bilateral removal of fallopian tube), removal of right essure coil).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, complication of device removal, depression, anxiety and dysmenorrhoea outcome was unknown and the pelvic pain, vaginal haemorrhage and menorrhagia had resolved.The reporter considered anxiety, complication of device removal, depression, device breakage, dysmenorrhoea, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: per insertion details: however, it did not release correctly.Part of the essure was in the fallopian lumen; however, part of it was still left in the apparatus.The apparatus was removed, and then physician attempted to grasp the coil with the hysteroscopic grasper.Multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil, so the essure procedure was halted.Discrepancy noted: in current f/up it was mentioned that she didn¿t undergo an essure confirmation test, but previously hysterosalpingogram was reported with result.Patient received treatment for events ¿abnormal bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: result: essure device was successfully occluded.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: multiple attempts were done.Part of the coil was removed.After multiple attempts, they could not fully remove the golden piece that is at the very end of the coil.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pfs received- outcome of pelvic pain , abnormal bleeding (vaginal, menorrhagia) updated to recovered / resolved.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: 8730230
• MDR Text Key: 149059661
• Report Number: 2951250-2019-03039
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: ESS305
• Device Lot Number: B94868
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; ATORVASTATIN; ATORVASTATIN; GLIMEPIRIDE; GLIMEPIRIDE; GLIMEPIRIDE; HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE; LEVOTHYROXINE; LEVOTHYROXINE; LEVOTHYROXINE; METFORMIN; METFORMIN; METFORMIN; ATORVASTATIN; GLIMEPIRIDE; HYDROCHLOROTHIAZIDE; LEVOTHYROXINE; METFORMIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR