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

Model Number ESS305

Device Problem Misfire (2532)

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

Event Type  malfunction  

Manufacturer Narrative

Follow-up information was received on 08-aug-2014: no new clinical information was provided.Follow-up information from 19-aug-2014: follow-up attempts were done with no response to date.Product technical complaint investigation and final assessment were received on 27-aug-2014: the bayer reference number for the ptc report is: (b)(4).Final assessment: the case is reopened to add ae and update rc.No new additional information for investigation.When a term like "falling apart" is used when describing a device event, it is difficult to determine the true nature of the event from the complaint description alone.Unless additional detail is provided in the event description, it is difficult to determine if the reporter is describing an event where the micro-insert actually broke into individual pieces, if the micro-insert bent or stretched into an unintended shape, and hence was considered by the reporter to be "broken", or if a different portion of the delivery catheter was broken off inside the patient.Failure mode/mechanism: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The insert's 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 the outer coils of the micro-insert partially deploy during user attempts to repositioning the device and the coil catheter is not fully retracted, the outer coils of the micro-insert could become entangled within the distal portion of the coil catheter.If the outer coils are partially deployed, the insert will begin to anchor itself to the fallopian tube.If the inner coil is still affixed to the delivery wire because all ifu steps have not yet been completed, subsequent attempts by the user to remove the catheter assembly may lead to either a stretching of the microinsert, stretching of the inner catheter large tight pitch coil, or breakage of the large tight pitch coil.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 microinsert.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 to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.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 any quality defect or device malfunction at this time.Conclusions: the possibility of pieces of the delivery system or micro-insert breaking off during the procedure is an anticipated event.According to the dfmea, the main consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Medical assessment: the reported events are not indicative of a quality defect per se.In this particular case a technical defect (breakage) was reported.The reported technical defect could not be evaluated in more detail due to lack of sample return.No further ae case reports have been received to date in relation to batch no.B66025.No batch signal could be identified.The review of the manufacturing- and release documentation of the concerned batch did not reveal any deviation or gave any reason to suspect a quality deficit (see technical statement).The technical assessment concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit.Company causality comment: this medically confirmed report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and experienced one coil went in and some parts and pieces that fell within the cavity and she had to go fishing for the other pieces that fell apart, coil misfired, and complication of device insertion.All the events are considered non-serious.The event one coil went in and some parts and pieces that fell within the cavity and she had to go fishing for the other pieces that fell apart interpreted as a device breakage and previously considered unlisted according to reference safety information for essure; was upon receipt of technical investigation updated to listed (anticipated).This event was regarded as other reportable incident due to device breakage.The remaining events are listed and non-incidents.During difficult insertions, single cases have been reported of essure breakage.In this particular case, it was reported that the coil misfired and one coil went in and some parts and pieces that fell within the cavity and the physician had to go fishing for the other pieces that fell apart.The doctor had to open up another package and the placement was successful.Based on the available information and due to lack of alternative explanation, causality between the events above and essure use was considered as related except the event coil misfired which was considered unrelated.A product technical analysis concluded the possibility of pieces of the delivery system or micro-insert breaking off during the procedure is an anticipated event.The technical assessment concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit.No further information is expected.

Event Description

This is a spontaneous case report received from a physician in united stated on 03/07/2014 which refers to a (b)(6) yr old female pt who had essure (fallopian tube occlusion insert) inserted.On (b)(6) 2014 essure (fallopian tube occlusion insert) was inserted with lot number b66025 (exp date 09/2016).It was reported that the coil misfired and one coil went in and some parts and pieces that fell within the cavity and the physician had to go fishing for the other pieces that fell apart.The doctor had to open up another package and the placement was successful.

Manufacturer Narrative

Company causality comment; this medically confirmed report refers to a (b)(6) yr old female pt who had essure (fallopian tube occlusion insert) inserted and experienced one coil went in and some parts and pieces that fell within the cavity and she had to go fishing for the other pieces that fell apart, coil misfired and complication of device insertion.All the events are considered non-serious.One coil went in and some parts and pieces that fell within the cavity and she had to go fishing for the other pieces that fell apart is unlisted in the reference safety info for essure while the remaining events are listed.The event on coil went in and some parts and pieces that fell within the cavity and she had to go fishing for the other pieces that fell apart (assumed as device breakage) was regarded as near-incident since the reporter stated a device breakage.During difficult insertion, single cases have been reported of essure breakage.In this particular case, was reported that the coil misfired and one coil went in and some parts and pieces that fell within the cavity and the physician had to go fishing for the other pieces fell apart.The doctor had to open up another package and the placement was successful.Based on the available info and due to lack of alternative explanation, causality between the events above and essure use was considered as related except the event coil misfired that was considered unrelated.

Manufacturer Narrative

Data correction: the product 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: 4015159
• MDR Text Key: 12175513
• Report Number: 2951250-2014-00322
• 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

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: ESS305
• Device Lot Number: B66025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR