MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problems Difficult or Delayed Positioning (1157); Use of Device Problem (1670)

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

Event Type  Injury  

Manufacturer Narrative

On march 3, 2017, bayer received a cluster of essure complaint reports originating from the (b)(4), device vigilance database via legal proceedings.Following receipt, bayer consulted (b)(4) in order to obtain the relevant case reference number information.On march 24, 2017, (b)(4) 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.

Event Description

This spontaneous case was reported by a physician and describes the occurrence of device deployment issue ("device deployed during positioning, even though the mechanism on the handle was not activated") and device difficult to use ("failure of placement due to technical problem.Change of device.") in a female patient who had essure (batch no.A02551) inserted.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced device deployment issue and device difficult to use.At the time of the report, the device deployment issue and device difficult to use outcome was unknown.The reporter provided no causality assessment for device deployment issue and device difficult to use with essure.The reporter commented: clinical consequences: risk of injury.Company causality comment: this spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and during the procedure the device deployed during positioning, even though the mechanism on the handle was not activated.This event, interpreted as device deployment issue, is anticipated in the reference safety information for essure.As the event occurred during essure insertion procedure, a causal relationship with suspect insert cannot be excluded.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

This spontaneous case was reported by a physician and describes the occurrence of device deployment issue ("device deployed during positioning, even though the mechanism on the handle was not activated") and complication of device insertion ("failure of placement due to technical problem.Change of device.") in a female patient who had essure (batch no.A02551) inserted.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced device deployment issue and complication of device insertion.At the time of the report, the device deployment issue and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion and device deployment issue with essure.The reporter commented: clinical consequences: risk of injury.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 18-jul-2017 for the following meddra preferred term: device deployment issue.The analysis in the global safety database revealed 284 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 12-jul-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: INSERT, TUBAL OCCLUSION
• 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; whippany, NJ 07981-0915
• MDR Report Key: 6537399
• MDR Text Key: 74417555
• Report Number: 2951250-2017-01856
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• 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: A02551
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2017
• 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