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 nurse in united states on (b)(6) 2014 which refers to a (b)(6) female patient who had an attempt of essure (fallopian tube occlusion insert) insertion on (b)(6) 2014.It was reported that patient was in the or (operating room) and physician had opened 3 essure devices until the time of this report; 1 device did not release the coil, 2 devices have broken, and there were screws inside the tubes.The ptc investigation result (ptc number (b)(4) ) received on 20-nov-2014 had discrepant information and a new ptc (b)(4) was provided.The product technical complaint investigation and final assessment were received on 25-nov-2014.The bayer reference number for the ptc report 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 (instructions for use) 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 20-nov-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 to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.The possibility of pieces of the delivery system or micro-insert breaking off and detachment difficulty events during the procedure are anticipated events.Medical assessment: this ptc was initiated due to a product quality issue in the context of a complicated device insertion.However, no adverse events were reported at this point in time.Neither batch number nor complaint sample were provided for further investigation.The technical assessment concluded unconfirmed quality defect.In summary, as no adverse events were reported at this point in time.There is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up information received on 01-dec-2014: it was reported that first device did not detach from insertion cannula for 15 minutes.Second and third devices appeared to deploy an additional part; it looked strange after deployment.There were only 2 or 3 coils visible, but additionally piece (perhaps the inner coil) was visible, so it was removed with a grasping forceps during hysteroscopy.Patient was fine after discharged home post-operatively.There were no relevant medical history or concurrent conditions.No related diagnostic tests were performed (ultrasound, flat plate x-ray, mri, cat-scan, relevant blood tests or allergy tests).No pathology results.No hysterectomy and salpingectomy were necessary.No perforation occurred.Hospitalization did not occur and treatment was not provided.Any previous gynecological intervention, problems and procedures were denied.Diagnostic hysteroscopy was normal.Company causality comment: this medically confirmed, spontaneous case report, refers to a female patient who had an attempt to insert essure (fallopian tube occlusion insert) and during the procedure 1 device did not release the coil, 2 devices have broken and there are screws inside the tubes/an additional piece (perhaps the inner coil) was visible.These events, interpreted as essure deployment issue and breakage were considered non-serious.Deployment issue is listed according to essure's reference safety information.Device breakage, previously considered unlisted, was, upon receipt of product technical investigation (ptc) updated to listed (anticipated).Single cases of essure breakage have been reported.In this particular case, as the reported events occurred during essure insertion procedure, a causal relationship with the suspect insert cannot be excluded.This case was considered other reportable incident due to device breakage.Other non-serious event was reported: 2nd and 3rd device appeared to deploy an additional part/there were only 2 to 3 coils visible/it looked strange after deployment.The product technical analysis concluded unconfirmed quality defect.There is no reason to suspect a causal relationship to a potential quality deficit.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: 4308391
• MDR Text Key: 5134712
• Report Number: 2951250-2014-00511
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• 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: 11/12/2014
• 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
• Patient Age: 30 YR