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

Model Number ESS305

Device Problems Break (1069); Separation Failure (2547)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/05/2014

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a nurse via regulatory authority (case# (b)(6)) in united states on (b)(6)-2014 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2014 with lot number b71765.The medical doctor was inserting essure sterilization coil via hysteroscopy when coil did not fully release into right fallopian tube.Only part of coil was inserted.Left fallopian tube went without problems.The events were considered medically important by reporter the product technical complaint investigation and final assessment were received on (b)(4)2014.The bayer reference number for the ptc report is: (b)(4).Final assessment detachment difficulty is defined as a failure of the micro-insert to detach (separate) from the delivery system.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper detachment: 1) rollback to initial hard stop.2) depress button.3) perform final rollback.Under normal circumstances, when the physician completes all deployment steps as outlined in the ifu, the micro-insert assembly will detach from the delivery wire and remain in the fallopian tube.Several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the microinsert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the insert's grip on the delivery wire, and potential manufacturing deficiencies.Since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert, the outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all are within manufacturing specifications.In this case, 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 are unable to confirm the device breakage.Conclusions: the possibility of a detachment difficulty event during the procedure and the possibility of pieces of the delivery system or micro-insert breaking off are anticipated events.According to the (b)(6), the main consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Medical assessment this ptc was initiated due to a reported product quality issue and usability issues.However, no adverse events have been reported at this point in time.No complaint sample was provided for further technical investigation.The batch documentation was reviewed by the rqu.The technical assessment concluded unconfirmed quality defect.Since no adverse events were reported, no batch signal review for similar adverse events could be conducted.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.The reported usability issue will be subject to post market surveillance monitoring.Company causality comment: this medically confirmed case report was received via regulatory authority and refers to a female patient who had an attempt to insert essure (fallopian tube occlusion insert) and during the procedure coil did not fully release into right fallopian tube.Only part of coil was inserted.These events interpreted as a device breakage and deployment issue were considered serious by the reporter due to medical importance.Device breakage during essure insertion was initially considered as unlisted according to essure's reference safety information; however upon receipt of product technical investigation (ptc) it was amended to listed, since ptc analysis concluded that the breakage is an anticipated event.The remaining event is listed.Single cases of essure breakage have been reported.In this particular case; considering that the reported events occurred in association with essure placement they were considered as related to the suspect insert.This case was regarded as other reportable incident due to the reported device malfunction.A product technical analysis was performed and concluded that there is no reason to suspect a causal relationship to a potential quality deficit based on this report.No further information can be obtained since this is a health authority case.

Manufacturer Narrative

Data correction: the code knh was replaced with hhs.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 4185187
• MDR Text Key: 5026186
• Report Number: 2951250-2014-00442
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2016
• Device Model Number: ESS305
• Device Lot Number: B7165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 54