MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a medical doctor in united states on (b)(6)-2016 which refers to a (b)(6)-year-old female patient who had essure (fallopian tube occlusion insert) inserted on (b)(6)-2016 for permanent sterilization.Per provider and operative note during retraction of the deployment process, the 5 most distal coils from the essure device fragmented away from the main coil that was left in the patients fallopian tube.This was the exact spot where the coil entered the ostium.Therefore, 5 coils would have been left exposed at the right tubal ostium conforming excellent placement of the device.These 5 coils that were fragmented were withdrawn from the endometrial cavity.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted.During the procedure, the 5 most distal coils from the essure device fragmented away from the main coil.These 5 coils were removed from the uterus.This event 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, limited information was provided.However, considering the event 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 event 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

Follow up information received on 08-sep-2016: quality-safety evaluation of product technical complaint (ptc) this adverse event report is related to a ptc and the bayer reference number for the ptc report is (b)(4).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 (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.No sample available for this investigation.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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the available information a product quality defect could not be confirmed but is considered plausible.Since no medical events or a batch number were reported at this point in time, the assessment of a relationship with a quality defect, as well as a batch investigation are not applicable.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted.During the procedure, the 5 most distal coils from the essure device fragmented away from the main coil.These 5 coils were removed from the uterus.This event was classified as anticipated upon receipt of technical analysis.Single cases of essure breakage have been reported, mainly during difficult insertions.In this particular case, limited information was provided.However, considering the event 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 event did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.According to technical analysis, a product quality defect could not be confirmed but is considered plausible.Follow-up attempts were performed with no response to date, thus no further information will be requested.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd.; milpitas CA 95035
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd., p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5554815
• MDR Text Key: 42949682
• Report Number: 2951250-2016-00222
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

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 Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• 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
• Patient Age: 50 YR