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

Model Number ESS305

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Swelling (2091)

Event Type  Injury  

Event Description

This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("disjointed strips noticed in black part of catheter when catheter was in the uterus.Part of these black parts came loose from the catheter and some of them were stuck on the catheter."), uterine enlargement ("uterus membrane was swollen"), complication of device insertion ("complication of device insertion") and complication of device insertion ("they are planning to do the insertion another day") in a female patient who received essure (batch no.D60143).On (b)(6) 2017, the patient started essure.On (b)(6) 2017, the patient experienced device breakage, uterine enlargement, complication of device insertion and complication of device insertion.At the time of the report, the device breakage, uterine enlargement, first episode of complication of device insertion and second episode of complication of device insertion outcome was unknown.The reporter provided no causality assessment for device breakage, uterine enlargement, the first episode of complication of device insertion and the second episode of complication of device insertion with essure.Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and it was reported that disjointed strips noticed in black part of catheter when catheter was in the uterus.Part of these black parts came loose from the catheter and some of them were stuck on the catheter.This event, interpreted as device breakage, is regarded as anticipated according to the reference safety information for essure.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.Additionally, non-serious events were reported.Further information and product technical analysis are being sought.

Manufacturer Narrative

Quality-safety evaluation of ptc: since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.Visual inspection was performed and it was confirmed that all components are present all ifu (instructions for use) steps were not initiated.Micro-insert was not deployed and it is still attached to the system.The scratches observed on the black mark are not a confirmed quality defect of production site, since there were also scratches observed in the coating section of the rest of catheter, therefore the parts were detached during the insertion in the hysteroscope.We were unable to confirm any quality defect or device malfunction at this time.We also 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.There was no event reported which indicates a new technical failure mode for the device.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on (b)(6) 2017: quality-safety evaluation of product technical complaint was received.Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and it was reported that disjointed strips noticed in black part of catheter when catheter was in the uterus.Part of these black parts came loose from the catheter and some of them were stuck on the catheter.This event, interpreted as device breakage, is regarded as anticipated according to the reference safety information for essure.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.Additionally, non-serious events were reported.The product technical investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Further information is being sought.

Manufacturer Narrative

This spontaneous case was reported by a nurse and describes the occurrence of device breakage ("disjointed strips noticed in black part of catheter when catheter was in the uterus.Part of these black parts came loose from the catheter and some of them were stuck on the catheter."), uterine enlargement ("uterus membrane was swollen"), the first episode of complication of device insertion ("complication of device insertion") and the second episode of complication of device insertion ("they are planning to do the insertion another day") in a female patient who had essure (batch no.D60143) inserted.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, uterine enlargement, the first episode of complication of device insertion and the second episode of complication of device insertion.At the time of the report, the device breakage, uterine enlargement and the last episode of complication of device insertion outcome was unknown.The reporter provided no causality assessment for device breakage, uterine enlargement, the first episode of complication of device insertion and the second episode of complication of device insertion with essure.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 24-apr-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1619 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 nr.D60143 - production date: 18-feb-2015 - expiration date: 28-feb-2018.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.Visual inspection was performed and it was confirmed that all components are present all ifu (instructions for use) steps were not initiated.Micro-insert was not deployed and it is still attached to the system.The scratches observed on the black mark are not a confirmed quality defect of production site, since there were also scratches observed in the coating section of the rest of catheter, therefore the parts were detached during the insertion in the hysteroscope.We were unable to confirm any quality defect or device malfunction at this time.We also 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.There was no event reported which indicates a new technical failure mode for the device.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 21-apr-2017: despite several requests (questionnaire), no further information could be obtained.Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and it was reported that disjointed strips noticed in black part of catheter when catheter was in the uterus.Part of these black parts came loose from the catheter and some of them were stuck on the catheter.This event, interpreted as device breakage, is regarded as anticipated according to the reference safety information for essure.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.Additionally, non-serious events were reported.The product technical investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Despite several requests, no further information could be obtained.

• 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. lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6398659
• MDR Text Key: 70026392
• Report Number: 2951250-2017-00839
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: ESS305
• Device Lot Number: D60143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2015
• 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