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

Model Number ESS305

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a medical doctor in united states on (b)(6) 2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) implanted on (b)(6) 2014, lot number b66021, for permanent contraception.On (b)(6) 2014, the essure coil placed fine on left side but the proximal part of outer coil, the silver band, fell off and went into uterus and silver band removed.Bilateral placement achieved.Ptc investigation result was received on 03-jan-2015.This adverse event report is related to a product technical complaint (ptc).(b)(4).Final assessment: 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.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.Since no product was returned for investigation, we cannot confirm this quality complaint; however, based on the complaint description provided, we are able to conclude that a quality issue is plausible.It is possible during the manufacturing assembly process a small gap was left between the inner coil and inner catheter (they should be butted together during assembly).When the outer coil of the micro-insert is wound down a small portion of the coil can become trapped in the gap.If a device has this issue, when the physician presses the button to release the microinsert, the outer coil may sever itself as it is being deployed from the catheter.This severing occurs inside the catheter prior to the pieces being deployed from the catheter.The severing of the coils inside the catheter does not pose a significant risk to the health of the patient.The possibility of pieces of the delivery system or micro-insert breaking off during the procedure is an anticipated event.The risk to the patient for this failure mode was assessed during the design process, and adequate risk mitigation actions were taken to minimize the residual risk as documented in the design fmea.Medical assessment: this product technical complaint was initiated due to reported product technical issue (breakage).The ae case refers also to a usability issue (complicated insertion).However, at this point in time no adverse events were reported.Since no adverse events have been reported, a batch investigation with respect to similar ae cases is not applicable.The batch documentation of the reported batch b66021 (production date 30-aug-2013 and expiration date 31-aug-2016) was reviewed.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect, but plausible.According to the technical assessment a quality defect was not confirmed but considered plausible.Based on the provided information the defect type corresponds to the following (b)(4): device breakage.However, an assessment regarding a causal relationship between a potential quality defect and an adverse event is not possible as no adverse event was reported.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) implanted and during essure insertion the proximal part of outer coil, the silver band, fell off and went into uterus.This event, interpreted as device breakage, is non-serious and upon receipt of the product technical analysis it was regarded as listed.During difficult insertion/removals, single cases have been reported of essure breakage.In this case, this event occurred during essure insertion.The silver band was removed.Bilateral placement was achieved.Given a compatible temporal relationship, causality between this event and suspect insert 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.The product technical analysis concluded unconfirmed quality defect, but plausible.According to the technical assessment a quality defect was not confirmed, but considered plausible.Further information is being sought.

Manufacturer Narrative

Follow-up attempts were done, with no response to date.Case considered closed on 12-jun-2015.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) implanted and during essure insertion the proximal part of outer coil, the silver band, fell off and went into uterus.This event, interpreted as device breakage, is non-serious and upon receipt of the product technical analysis it was regarded as listed.During difficult insertion/removals, single cases have been reported of essure breakage.In this case, this event occurred during essure insertion.The silver band was removed.Bilateral placement was achieved.Given a compatible temporal relationship, causality between this event and suspect insert 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.The product technical analysis concluded unconfirmed quality defect but plausible.According to the technical assessment a quality defect was not confirmed but considered plausible.Despite follow-up attempts, no further information was obtained.

Manufacturer Narrative

Data correction for us reporting: 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: 4407669
• MDR Text Key: 20978699
• Report Number: 2951250-2015-00020
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2017

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 Expiration Date: 08/31/2016
• Device Model Number: ESS305
• Device Lot Number: B66021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 01/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/08/2015; 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2013
• 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