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

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Perforation (2001); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Spontaneous case was reported by a lawyer and describes the occurrence of perforation ("perforation"), device breakage ("device fracture"), device dislocation ("migration of device") and autoimmune disorder ("autoimmune issue") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), pelvic pain ("pain"), anxiety ("anxiety") and depression ("depression").The patient was treated with surgery ( surgery to remove essure in (b)(6) 2016 and on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the perforation, device breakage, device dislocation, autoimmune disorder, pelvic pain, anxiety and depression outcome was unknown.The reporter considered anxiety, autoimmune disorder, depression, device breakage, device dislocation, pelvic pain and perforation to be related to essure.The reporter commented: plaintiff claimed: need for additional surgeries.Incident.No lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Spontaneous case was reported by a lawyer and describes the occurrence of perforation ("perforation"), device breakage ("device fracture"), device dislocation ("migration of device") and autoimmune disorder ("autoimmune issue") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), pelvic pain ("pain"), anxiety ("anxiety") and depression ("depression").The patient was treated with surgery (surgery to remove essure in (b)(6) 2016 and on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the perforation, device breakage, device dislocation, autoimmune disorder, pelvic pain, anxiety and depression outcome was unknown.The reporter considered anxiety, autoimmune disorder, depression, device breakage, device dislocation, pelvic pain and perforation to be related to essure.The reporter commented: plaintiff claimed: need for additional surgeries.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-oct-2018: quality safety evaluation of ptc.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ('perforation'), device breakage ('device fracture'), device dislocation ('migration of device') and autoimmune disorder ('autoimmune issue') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), pelvic pain ("pain"), anxiety ("anxiety"), depression ("depression"), dizziness ("dizziness") and raynaud's phenomenon ("raynaud's disease") and was found to have heart rate increased ("rapid heart rate").The patient was treated with surgery (surgery to remove essure in (b)(6) 2016 and on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the perforation, device breakage, device dislocation, autoimmune disorder, pelvic pain, anxiety, depression, heart rate increased, dizziness and raynaud's phenomenon outcome was unknown.The reporter considered anxiety, autoimmune disorder, depression, device breakage, device dislocation, dizziness, heart rate increased, pelvic pain, perforation and raynaud's phenomenon to be related to essure.The reporter commented: plaintiff claimed: need for additional surgeries.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: this is a retention case.All the information from deletion case (b)(4) (duplicate) including references, sources document, reporter has been transferred to this case.No new follow-up information was received from the reporter.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 perforation ('perforation'), device breakage ('device fracture'), device dislocation ('migration of device') and autoimmune disorder ('autoimmune issue') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), pelvic pain ("pain"), anxiety ("anxiety"), depression ("depression"), dizziness ("dizziness") and raynaud's phenomenon ("raynaud's disease") and was found to have heart rate increased ("rapid heart rate").The patient was treated with surgery (surgery to remove essure in (b)(6) 2016 and on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the perforation, device breakage, device dislocation, autoimmune disorder, pelvic pain, anxiety, depression, heart rate increased, dizziness and raynaud's phenomenon outcome was unknown.The reporter considered anxiety, autoimmune disorder, depression, device breakage, device dislocation, dizziness, heart rate increased, pelvic pain, perforation and raynaud's phenomenon to be related to essure.The reporter commented: plaintiff claimed: need for additional surgeries.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs received: events: rapid heart rate, dizziness, and raynaud's disease were 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: 7994359
• MDR Text Key: 124660570
• Report Number: 2951250-2018-04392
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention