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

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

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 (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2014 with lot number c91764.It was reported that proximal part of the insert fell off.It was retrieved and placed another.No injury to the patient.Bilateral placement achieved.The outcome of the event was recovered / resolved.Ptc investigation result was received on (b)(6) 2015.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc local number (b)(4) and ptc global number (b)(4).Final assessment: failure mode/mechanism: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The inserts outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.As of (b)(6) 2014, 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, 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.We were unable to confirm any quality defect or device malfunction at this time.The possibility of micro-insert breaking during the procedure is an anticipated event.The risk to the patient for these types of breakage events were 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 also refers 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 c91764 (production date 01-aug-2014 and expiration date 31-aug-2017) was reviewed.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect and noted that this event is anticipated per design fmea.In summary, 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 (b)(6) female patient who had an attempt to insert essure (fallopian tube occlusion insert) and during the procedure proximal part of the insert fell off/retrieved and placed another device.The event, seen as device breakage, is non-serious and upon receipt of the product technical analysis it was regarded as listed.During difficult insertions, single cases of device breakage have been reported.In this case, according to physician, proximal part of the insert fell off during the insertion.It was retrieved and another device was placed.Since breakage was reported and occurred during insertion procedure (complication of device insertion), causality with essure use is assessed as related and the case is regarded as other reportable incident.The product technical analysis concluded unconfirmed quality defect and noted that this event is anticipated.

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: 4421823
• MDR Text Key: 18293648
• Report Number: 2951250-2015-00030
• 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
• 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: 08/31/2017
• Device Model Number: ESS305
• Device Lot Number: C91764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 01/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR