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

Model Number ESS305

Device Problems Difficult or Delayed Positioning (1157); Physical Resistance (2578); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a nurse in united states on 29-sep-2015 which refers to a female patient of unspecified age who had an attempt of essure (fallopian tube occlusion insert) insertion on (b)(6) 2015.Nurse reported that a patient had 6 coils trailing from left insert into the uterus, with a string coming out through the cervix and into her vaginal canal.She wants to know how to remove it.According to reporter, medical doctor tried to insert on patient's left side; she met some resistance but deployed.In addition, it was reported that there were some trailing coils but insert had a metal insert sticking out within it.As described by health care professional, it sounds like she was seeing the inner coil sticking past the outer coil.She pulled out the inner coil and now there are coils left and she cannot get them out.The coils were anchored in the fallopian tube.Medical doctor asked about placing other insert and was advised not to do it until it is assessed to determine what is left in it.She has not placed insert on right side.She had no access to x-ray at that time and said she will determine next steps.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had an attempt of essure (fallopian tube occlusion insert) insertion.During the procedure, physician saw a string coming out through the cervix and into the vaginal canal.It sounded like she was seeing the inner coil sticking past the outer coil.The physician pulled out the inner coil and now there are coils left.These events were regarded as a handling issue (essure stretched during the procedure) followed by a possible device breakage.Only device breakage is unlisted according to essure's reference safety information.Single cases of essure breakage have been reported, mainly during difficult insertions.In this particular case, physician experienced resistance to place essure.This suggests a difficult insertion, which may have contributed for the possible device breakage.Considering these events occurred in association with essure procedure, causality with the suspect insert cannot be excluded.This case was regarded as other reportable incident, as although the reported events did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.A product technical analysis and follow-up information will be requested.

Manufacturer Narrative

-result and assessment of the product technical complaint investigation received on 12-nov-2015: this adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: (b)(4).Final assessment: 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 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.For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.The possibility of micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: no product quality defect was confirmed.Furthermore no medical events were reported at this point in time.The technical assessment concluded unconfirmed quality defect.A review of similar cases is not applicable as no batch number was reported.Based on the available information, there is no relationship to a quality defect.Company causality comment this medically confirmed, spontaneous case report refers to a female patient who had an attempt of essure (fallopian tube occlusion insert) insertion.During the procedure, physician saw a string coming out through the cervix and into the vaginal canal.It sounded like she was seeing the inner coil sticking past the outer coil.The physician pulled out the inner coil and now there are coils left.These events were regarded as a handling issue (essure stretched during the procedure) followed by a possible device breakage.Only device breakage is unlisted according to essure's reference safety information, and it was considered listed upon receipt of the product technical analysis.Single cases of essure breakage have been reported, mainly during difficult insertions.In this particular case, physician experienced resistance to place essure.This suggests a difficult insertion, which may have contributed for the possible device breakage.Considering these events occurred in association with essure procedure, causality with the suspect insert cannot be excluded.This case was regarded as other reportable incident, as although the reported events 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.Based on the available information, there is no relationship to a quality defect.Follow-up information will be requested.

Manufacturer Narrative

Follow-up from 04-jan-2016: follow-up attempts have been completed, with no response to date.No further follow-up will be pursued.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had an attempt of essure (fallopian tube occlusion insert) insertion.During the procedure, physician saw a string coming out through the cervix and into the vaginal canal.It sounded like she was seeing the inner coil sticking past the outer coil.The physician pulled out the inner coil and now there are coils left.These events were regarded as a handling issue (essure stretched during the procedure) followed by a possible device breakage.Only device breakage is unlisted according to essure's reference safety information, and it was considered listed upon receipt of the product technical analysis.Single cases of essure breakage have been reported, mainly during difficult insertions.In this particular case, physician experienced resistance to place essure.This suggests a difficult insertion, which may have contributed for the possible device breakage.Considering these events occurred in association with essure procedure, causality with the suspect insert cannot be excluded.This case was regarded as other reportable incident, as although the reported events 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.Based on the available information, there is no relationship to a quality defect.Further information could not be obtained.

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: 5177969
• MDR Text Key: 29253507
• Report Number: 2951250-2015-01243
• 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: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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