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

Model Number ESS305

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Fallopian Tube Perforation (4506); Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous case was reported by a healthcare professional and describes the occurrence of medical device removal ("cp stated that a patient is being scheduled for essure removal") in a female patient who had essure inserted.There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On an unknown date she underwent medical device removal (seriousness criterion intervention required).No causality assessment was received for essure with regard to medical device removal.The reporter commented: hcp stated that a patient is being scheduled for essure removal.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The following amendment was made: after internal review, the reported event hcp stated that a patient is being scheduled for essure removal was recoded to the meddra llt: medical device removal and the case was upgraded to serious incident.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 healthcare professional and describes the occurrence of medical device removal ("cp stated that a patient is being scheduled for essure removal") in a female patient who had essure inserted.There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On an unknown date she underwent medical device removal (seriousness criterion intervention required).No causality assessment was received for essure with regard to medical device removal.The reporter commented: hcp stated that a patient is being scheduled for essure removal.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 14-jul-2023: quality safety evaluation of ptc.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 healthcare professional and describes the occurrence of fallopian tube perforation ("tubal perforation") in an adult female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of pelvic adhesions, pelvic pain, endometriosis and overweight.In 2016, the patient had essure inserted.In 2016 she experienced device placement issue ("incorrect placement").Essure was removed on (b)(6) 2023.An unknown time later she experienced fallopian tube perforation (seriousness criteria medically important and intervention required) and pelvic pain ("pelvic pain").The patient was treated with surgery (bilateral salpingectomy and cornuectomy).The reporter considered device placement issue, fallopian tube perforation and pelvic pain to be related to essure administration.The reporter commented: removal was performed at patient's request.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 28.6 kg/sqm.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 07-sep-2023: quality safety evaluation of ptc.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 healthcare professional and describes the occurrence of fallopian tube perforation ("tubal perforation") in an adult female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of pelvic adhesions, pelvic pain, endometriosis and overweight.In 2016, the patient had essure inserted.In 2016 she experienced device placement issue ("incorrect placement").An unknown time later, she experienced fallopian tube perforation (seriousness criteria medically important and intervention required) and pelvic pain ("pelvic pain").The patient was treated with surgery (bilateral salpingectomy and cornuectomy).Essure was removed on (b)(6) 2023.The reporter considered device placement issue, fallopian tube perforation and pelvic pain to be related to essure administration.The reporter commented: removal was performed at patient's request.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 28.6 kg/sqm.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 24-aug-2023: event updated from "cp stated that a patient is being scheduled for essure removal" to "tubal perforation".New events "pelvic pain" and "incorrect placement" added.Product start and stop date added.Patient details added.Medical history added.Reporters causality updated.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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 17302718
• MDR Text Key: 318923337
• Report Number: 2951250-2023-02699
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female
• Patient Weight: 85 KG