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

Model Number ESS205

Device Problems Break (1069); Difficult to Insert (1316); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of device breakage ("after retraction of system, outer part of the insert remained in the tube, seen on radiological check"), complication of device removal ("after retraction of system, outer part of the insert remained in the tube, seen on radiological check"), device deployment issue ("impossible to release the insert in the left uterine tube") and complication of device insertion ("two further attempts with two other kits failed, bilateral sterilisation was not performed") in a female patient who received essure (ess205) (batch no.621808) for female sterilisation.On (b)(6) 2007, the patient started essure (ess205).On (b)(6) 2007, the same day after starting essure (ess205), the patient experienced device breakage, complication of device removal, device deployment issue and complication of device insertion.At the time of the report, the device breakage, complication of device removal, device deployment issue and complication of device insertion outcome was unknown.The reporter provided no causality assessment for device breakage, complication of device removal, device deployment issue and complication of device insertion with essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date: x-ray result was part of outer coil of insert remained in tube (abnormal nos).Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and it was reported that after retraction of system, outer part of the insert remained in the tube, seen on radiological check (seen as device breakage).The event device breakage is regarded as anticipated according to the reference safety information for essure.In this particular case, it was impossible to release the insert in the left uterine tube (seen as device deployment issue) and two further attempts with two other kits failed, bilateral sterilisation was not performed (device insertion failed).As the device breakage occurred during essure insertion procedure, a causal relationship with essure cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Further information and product technical analysis are being 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 pharmacist and describes the occurrence of device breakage ("after retraction of system, outer part of the insert remained in the tube, seen on radiological check"), complication of device removal ("after retraction of system, outer part of the insert remained in the tube, seen on radiological check"), device deployment issue ("impossible to release the insert in the left uterine tube") and complication of device insertion ("two further attempts with two other kits failed, bilateral sterilisation was not performed") in a female patient who had essure (ess205) (batch no.621808) inserted for female sterilisation.On (b)(6) 2007, the patient had essure (ess205) inserted.On the same day, the patient experienced device breakage, complication of device removal, device deployment issue and complication of device insertion.At the time of the report, the device breakage, complication of device removal, device deployment issue and complication of device insertion 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 (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: part of outer coil of insert remained in tube (abnormal nos) the list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra 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 1623 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: lot#: 621808 - production date: dec-2006 - expiration date: nov-2008 sample not available.We conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.No capa investigation is required at this time because the possibility of a detachment difficulty event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the available information, a product quality defect could not be confirmed but is considered plausible.A relationship between the reported medical events and a quality defect cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.No similar ae case reports have been received to date in relation to the reported batch.Most recent follow-up information incorporated above includes: on 4-may-2017: quality safety evaluation of ptc.Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and it was reported that after retraction of system, outer part of the insert remained in the tube, seen on radiological check (seen as device breakage).The event device breakage is regarded as anticipated according to the reference safety information for essure.In this particular case, it was impossible to release the insert in the left uterine tube (seen as device deployment issue) and two further attempts with two other kits failed, bilateral sterilisation was not performed (device insertion failed).As the device breakage occurred during essure insertion procedure, a causal relationship with essure cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.A product technical analysis resulted in an unconfirmed but plausible product quality defect.No similar adverse event case reports have been received to date in relation to the reported batch.Further information could not be obtained from the reporter.

• 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; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6534647
• MDR Text Key: 74310680
• Report Number: 2951250-2017-01790
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS205
• Device Lot Number: 621808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 05/01/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/02/2017; 05/19/2017
• 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