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

Model Number ESS305

Device Problems Break (1069); Separation Failure (2547)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a pharmacist and describes the occurrence of device breakage ("release problem occurred: only a part of the implant was placed"), device deployment issue ("release problem occurred: only a part of the implant was placed") and complication of device insertion ("release problem occurred: only a part of the implant was placed") in a (b)(6) year-old female patient who had essure (batch no.E22516) inserted.Medical conditions: the patient had only one ovary.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, device deployment issue and complication of device insertion.At the time of the report, the device breakage, device deployment issue and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion, device breakage and device deployment issue with essure.The reporter commented: no cause related to the patient could explain the release problem.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on (b)(6) 2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1.640 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Company causality comment: at the time of reporting, 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 pharmacist and describes the occurrence of device breakage ("release problem occurred: only a part of the implant was placed"), device deployment issue ("release problem occurred: only a part of the implant was placed") and complication of device insertion ("release problem occurred: only a part of the implant was placed") in a (b)(6) female patient who had essure (batch no.E22516) inserted.Medical conditions: the patient had only one ovary.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, device deployment issue and complication of device insertion.At the time of the report, the device breakage, device deployment issue and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion, device breakage and device deployment issue with essure.The reporter commented: no cause related to the patient could explain the release problem.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on (b)(6) 2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1.664 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Most recent follow-up information incorporated above includes: on 1-aug-2017: quality-safety evaluation of ptc incident at the time of reporting, 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 pharmacist and describes the occurrence of device breakage ("release problem occurred: only a part of the implant was placed") and complication of device insertion ("release problem occurred: only a part of the implant was placed") in a 40-year-old female patient who had essure (batch no.E22516) inserted.Other product or product use issues identified: device deployment issue "release problem occurred: only a part of the implant was placed" on (b)(6) 2017.Medical conditions: the patient had only one ovary.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage and complication of device insertion.At the time of the report, the device breakage and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion and device breakage with essure.The reporter commented: no cause related to the patient could explain the release problem.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-oct-2018: quality safety evaluation for ptc.Incident: at the time of reporting, 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.

• 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: 6687732
• MDR Text Key: 79779312
• Report Number: 2951250-2017-02427
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: ESS305
• Device Lot Number: E22516
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR