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

Model Number ESS305

Device Problems Break (1069); Migration or Expulsion of Device (1395); Sticking (1597); Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a physician ((b)(4)) and describes the occurrence of device breakage ("the purple handle that allows for insertion of the material broke into three parts and during release, the insert came apart") in a (b)(6) female patient who received essure (batch no.A69943).The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient started essure.On (b)(6) 2013, the same day of starting essure, the patient experienced device breakage (seriousness criteria medically significant and clinically significant/intervention required), device deployment issue ("during release, the insert came apart and, as a result, the insert became stuck in the wrong place"), device difficult to use ("it was necessary to remove it in pieces due to difficulty retrieving all of it") and complication of device insertion ("another package had to be opened").The patient was treated with surgery (switch to laparoscopy).Essure was withdrawn.At the time of the report, the device breakage, device deployment issue, device difficult to use and complication of device insertion outcome was unknown.The reporter provided no causality assessment for device breakage, device deployment issue, device difficult to use and complication of device insertion with essure.The reporter commented: during placement of one essure device, the purple handle that allows for insertion of the material broke into three parts.In addition, during release, the insert came apart and, as a result, the insert became stuck in the wrong place.It was therefore necessary to remove it in pieces due to difficulty retrieving all of it.Another package had to be opened.Company causality comment: this medically confirmed spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and during insertion procedure the purple handle that allows for insertion of the material broke into three parts and during release, the insert came apart( seen as device breakage).A laparoscopy was necessary to remove the insert stuck in the wrong place.The reported event is serious due to medical importance and anticipated in essure's reference safety information.During difficult insertions device breakage may occur.In this present case, during placement of one essure device, the purple handle that allows for insertion of the material broke into three parts.In addition, during release, the insert came apart and, as a result, the insert became stuck in the wrong place.It was therefore necessary to remove it in pieces due to difficulty retrieving all of it and a laparoscopy was performed.Taking to account that breakage occurred during essure insertion causality cannot be excluded.This case was regarded as incident since surgical intervention to device removal was required.The product technical analysis and further information has been sought.

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 and describes the occurrence of device breakage ("the purple handle that allows for insertion of the material broke into three parts and during release, the insert came apart") in a (b)(6) year-old female patient who had essure (batch no.A69943) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "it was necessary to remove it in pieces due to difficulty retrieving all of it" on (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device deployment issue ("during release, the insert came apart and, as a result, the insert became stuck in the wrong place") and complication of device insertion ("another package had to be opened").The patient was treated with surgery (switch to laparoscopy).Essure was removed on (b)(6) 2013.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: during placement of one essure device, the purple handle that allows for insertion of the material broke into three parts.In addition, during release, the insert came apart and, as a result, the insert became stuck in the wrong place.It was therefore necessary to remove it in pieces due to difficulty retrieving all of it.Another package had to be opened.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)(4) 2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1.653 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 (b)(4) 2017: quality safety evaluation of ptc: unable to confirm complaint.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: 6533378
• MDR Text Key: 74024285
• Report Number: 2951250-2017-01839
• 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: 07/21/2017

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 Model Number: ESS305
• Device Lot Number: A69943
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR