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

Catalog 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  malfunction  

Event Description

This spontaneous case was reported by a physician (b)(6) and describes the occurrence of device deployment issue and complication of device insertion ("release of insert impossible"), and device difficult to use ("prolongation of operative time with accompanying risks") in a female patient who received essure (batch no.628059).On (b)(6) 2009, the patient started essure.On (b)(6) 2009, the same day of starting essure, the patient experienced device deployment issue, complication of device insertion and device difficult to use.At the time of the report, the device deployment issue, complication of device insertion and device difficult to use outcome was unknown.The reporter provided no causality assessment for device deployment issue, complication of device insertion and device difficult to use with essure.The reporter commented: three incidents in 4 months with the essure method (see reporter's two linked case #s (b)(4) with same (b)(6)).Prolongation of operative time with accompanying risks.Company causality comment: this spontaneous case report refers to a female patient who an attempt to have essure inserted and stated that release of insert was impossible.This event, seen as device deployment issue, is anticipated in the reference safety information for essure.Based on the nature of this event and also based on the fact that it occurred during insertion procedure, causality was assessed as related.This case was regarded as other reportable incident, as although the event did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Product technical analysis and follow-up 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 a physician ((b)(4)) and describes the occurrence of device deployment issue ("stent was released into the left fallopian tube but a little too far") and device difficult to use ("prolongation of operative time with accompanying risks") in a (b)(6) female patient who had essure (batch no.628059) inserted.On (b)(6) 2009, 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: no injury occurred.Easy post-operative period - discharged the same day.Three incidents in 4 months with the essure method ((b)(4)).Prolongation of operative time with accompanying risks.Most recent follow-up information incorporated above includes: on 4-may-2017: physician returned essure device breakage questionnaire: pat.Age added, essure insertion date added.Reporter name added.There was no device breakage or insertion failure, as revealed during the laparoscopic tubal ligation in the fu here.Event was changed from "release of insert impossible" to "stent was released into the left fallopian tube but a little too far".Device is not available.Company causality comment: this spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and it was reported that stent was released into the left fallopian tube but a little too far (previously reported as release of insert impossible).It was confirmed that no device breakage occurred.This event, seen as device placement at incorrect location, is anticipated in the reference safety information for essure.Based on the nature of this event and also based on the fact that it occurred during insertion procedure, causality was assessed as related.This case was not regarded as incident since incident criteria was not met.Product technical analysis is expected.

• 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: 6534075
• MDR Text Key: 74307059
• Report Number: 2951250-2017-01829
• 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,Followup
• Report Date: 05/23/2017

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ESS305
• Device Lot Number: 628059
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• 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
• Patient Age: 38 YR