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

Model Number ESS305

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

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

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in united states on (b)(6) 2014 which refers to a (b)(6)-year-old female patient who had essure (fallopian tube occlusion insert) implanted on (b)(6) 2014, lot number c95076, for permanent sterilization.At time of essure insertion, the health care professional placed the patient's right side successfully.When she went to place the left side, the device deployed in the tube but would not detach from the catheter wire.The physician could not get it to separate.She had the scope and catheter in patient cavity and went thru series of techniques to help it detach, make sure wheel on handle was rotated all the way back, depressed the button and rotated the handle back and forth, and it would still would not release.When trying to release, the coil actually broke in a non desirable position.The physician got an x-ray, two flat plates.She has the images but does not have the verbal assessment.Follow-up received on (b)(6) 2014.Product technical complaint investigation and final assessment were received: this adverse event report is related to a product technical complaint and was initiated due to a product quality issue and a usability issue.The bayer reference number for the ptc report is (b)(4) and the local number is (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 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.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.Medical assessment: this ptc was initiated due to a product quality issue.In addition, the adverse event case refers to a usability issue.However, no adverse events have been reported.The batch documentation of the reported batch was reviewed.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect.Since no adverse events have been reported, a batch investigation with respect to similar ae cases is not applicable.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Company causality comment: this medically confirmed and spontaneous case report refers to a (b)(6)-year-old female patient who had an essure (fallopian tube occlusion insert) inserted for permanent contraception and, during insertion procedure, when trying to release, the coil actually broke in a non desirable position.The event when trying to release, the coil actually broke in a non desirable position, seen as a device breakage is non-serious and was previously regarded as unlisted according to the reference safety information for essure; however upon receipt of the product technical analysis (ptc), which stated that micro-insert breaking off during the procedure is an anticipated event; it was amended to listed.During difficult insertions, single cases of essure breakage have been reported.In this particular case, the reported physician stated that, due to a device deployment issue, the essure left coil broke during insertion.Given the nature of the reported event, and considering that it occurred in connection with insertion procedure, company assesses it as related to essure.This case was regarded as other-reportable incident as it could have led to serious deterioration of health if it had occurred under less fortunate circumstances.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.Follow-up information is expected.

Manufacturer Narrative

Case considered closed on 13-may-2015.Upon internal review performed on 27-may-2015, this case was updated with information from duplicated report.The procedure was performed in office by a physician who was experienced with essure.The patient received conscious sedation and was comfortable.The first device was inserted without problems.The second device was placed into tube and the physician stated that the gold band was clearly visible outside ostium (of note, prior to deployment the physician's assistant rotated the device in order to make sure that it was the gold band that was visible).The deployment process was performed and the physician believed that she could see the deployed outer coils at the ostium.After rolling back the thumbwheel second time, the delivery catheter appeared to remain attached.The sales representative that was present advised the physician to wait a few minutes.She did not wait long and rotated the device in an attempt to detach it.She was again advised to wait in case there was a degree of tubal spasm.The physician continued to attempt detachment and, at that point, the outer coil broke (more than 50 %, according to her).The delivery catheter then detached.There was still coil left in the tube, which the physician removed with forceps, and also an unwound coil (unclear if it was from delivery catheter), which she attempted to remove.Wire was left inside of the tube.Photos of the coils and delivery catheter were taken, and it appeared that the outer coil was detached and caught on the applicator (it was the distal portion of the coil and it contained approximately 22 coils).A separate photo of the proximal portion of the outer coil was also available and it showed approximately 7 coils attached or next to unidentified material (probably pet fibers) and a stretched out wire.The delivery catheter was entirely intact, so it appeared that the wire was part of the inner coil.A flat plate was performed by the physician and it showed what appeared to be the ball tip of the inner coil and a density consistent with the inner coil, with no other markers.No causality assessment was provided.Company causality comment: this medically confirmed and spontaneous case report refers to a (b)(6) female patient who had an essure (fallopian tube occlusion insert) inserted for permanent contraception and, during insertion procedure, when trying to release, the coil actually broke in a non desirable position.This event, seen as a device breakage is non-serious and was previously regarded as unlisted according to the reference safety information for essure; however upon receipt of the product technical analysis (ptc), which stated that micro-insert breaking off during the procedure is an anticipated event; it was amended to listed.During difficult insertions, single cases of essure breakage have been reported.In this particular case, the reported physician stated that, due to a device deployment issue, the essure left coil broke during insertion.Given the nature of the reported event, and considering that it occurred in connection with insertion procedure, company assesses it as related to essure.This case was regarded as other-reportable incident as it could have led to serious deterioration of health if it had occurred under less fortunate circumstances.Product technical complaint (ptc) analysis concluded there is no reason to suspect quality defect of the product.No further information is expected.

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: 4397843
• MDR Text Key: 5308538
• Report Number: 2951250-2015-00018
• 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: 01/08/2015
• 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: C95076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR