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

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("just when the insert was to be released and the catheter withdrawn, a technical problem occurred.The catheter became detached from the handle and remained stuck in the insert"), complication of device insertion ("just when the insert was to be released and the catheter withdrawn, a technical problem occurred.The catheter became detached from the handle and remained stuck in the insert"), device deployment issue ("just when the insert was to be released and the catheter withdrawn, a technical problem occurred.The catheter became detached from the handle and remained stuck in the insert") and device difficult to use ("an attempt was made to remove the catheter, however it remained fixed to the intra-luminal part of insert.The catheter remained, for the most part, within the uterus.") in a female patient who had essure (batch no.731817) inserted.On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced device breakage, complication of device insertion, device deployment issue and device difficult to use.At the time of the report, the device breakage, complication of device insertion, device deployment issue and device difficult to use outcome was unknown.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue and device difficult to use with essure.Company causality comment: this spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and just when the insert was to be released and the catheter withdrawn, a technical problem occurred.The catheter became detached from the handle and remained stuck in the insert.This event, interpreted as device breakage and device deployment issue, is anticipated in the reference safety information for essure.In the present case the events occurred during essure insertion procedure, therefore causality with essure cannot be excluded.An attempt was made to remove the catheter, however it remained fixed to the intra-luminal part of insert.The catheter remained, for the most part, within the uterus.Although there was no reported death or serious health deterioration, this might have occurred under less fortunate circumstances and therefore case was regarded as a reportable incident.A product technical analysis and further information are expected.

Manufacturer Narrative

On march 3, 2017, bayer received a cluster of essure complaint reports originating from the ansm, health authority of (b)(4), device vigilance database via legal proceedings.Following receipt, bayer consulted ansm in order to obtain the relevant case reference number information.On march 24, 2017, ansm provided the available corresponding case reference numbers to bayer.Upon receipt of this information bayer evaluated and processed the cluster of essure reports within the global safety database by april 12, 2017.

Manufacturer Narrative

This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("just when the insert was to be released and the catheter withdrawn, a technical problem occurred.The catheter became detached from the handle and remained stuck in the insert"), complication of device insertion ("just when the insert was to be released and the catheter withdrawn, a technical problem occurred.The catheter became detached from the handle and remained stuck in the insert"), device deployment issue ("just when the insert was to be released and the catheter withdrawn, a technical problem occurred.The catheter became detached from the handle and remained stuck in the insert") and complication of device removal ("an attempt was made to remove the catheter, however it remained fixed to the intra-luminal part of insert.The catheter remained, for the most part, within the uterus.") in a female patient who had essure (batch no.731817) inserted.On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced device breakage, complication of device insertion, device deployment issue and complication of device removal.At the time of the report, the device breakage, complication of device insertion, device deployment issue and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device insertion, complication of device removal, device breakage and device deployment issue with essure.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 24-oct-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1.826 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.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-oct-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.

• 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: k. shaw lamberson ; 100 bayer blvd, p.o. box 915; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6534705
• MDR Text Key: 74281838
• Report Number: 2951250-2017-01813
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 731817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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