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

Model Number ESS305

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a medical doctor in united states on 22-oct-2015 and 23-oct-2015 which refer to a (b)(6) female patient who had an attempt to have essure 305 (fallopian tube occlusion insert) inserted (lot number dog929) on (b)(6) 2015 and experienced micro insert broken (deployed but half of the outer coils were broken and fell into uterus).He wheeled back and heard an odd crunching noise and it felt funny.He then pushed the button and it deployed but half of the outer coils were broken and fell into uterus.She had no injury.The health care provider was able to retrieve all of the pieces and removed the inner coil from the fallopian tubes.The procedure was stopped (bilateral placement not achieved), it had taken 24 minutes and the procedure was stopped.Company causality comment this is a medically confirmed spontaneous case report that refers to a (b)(6) female consumer who had an attempt to have essure 305 (fallopian tube occlusion insert) inserted but the micro insert broke (deployed but half of outer coils were broken and fell in uterus).All pieces were retrieved from uterus and the inner coil from the fallopian tube was also removed at the same day of insertion.She had no injury.Since the breakage occurred during insertion it is unlisted in the reference safety information for essure.Considering the nature of this event, a causal relationship with essure cannot be excluded.This case is regarded as other reportable incident due to device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Further information (breakage questionnaire) and a product technical complaint are being sought.

Manufacturer Narrative

Ptc investigation result received on 12-nov-2015 ptc global number (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 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 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.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 is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information no product quality defect was confirmed/identified moreover, no medical events were reported.A review of similar cases for this batch is not applicable as no medical events were reported.In summary, based on the available information the assessment of a causal relationship is not applicable as no medical events were reported and no quality defect was confirmed.Company causality comment: this is a medically confirmed spontaneous case report that refers to a (b)(6) female consumer who had an attempt to have essure 305 (fallopian tube occlusion insert) inserted but the micro insert broke (deployed but half of outer coils were broken and fell in uterus).All pieces were retrieved from uterus and the inner coil from the fallopian tube was also removed at the same day of insertion.She had no injury.Since the breakage occurred during insertion it is unlisted in the reference safety information for essure.Considering the nature of this event, a causal relationship with essure cannot be excluded.This case is regarded as other reportable incident due to device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Based on the available information, the assessment of a causal relationship is not applicable as no medical events were reported and no quality defect was confirmed.Further information (breakage questionnaire) is being sought.

Manufacturer Narrative

Follow up 05-feb-2016: follow-up attempts were done with no response to date.Company causality comment: this is a medically confirmed spontaneous case report that refers to a (b)(6) female consumer who had an attempt to have essure 305 (fallopian tube occlusion insert) inserted but the micro insert broke (deployed but half of outer coils were broken and fell in uterus).All pieces were retrieved from uterus and the inner coil from the fallopian tube was also removed at the same day of insertion.She had no injury.Since the breakage occurred during insertion it is unlisted in the reference safety information for essure.Considering the nature of this event, a causal relationship with essure cannot be excluded.This case is regarded as other reportable incident due to device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Based on the available information, the assessment of a causal relationship is not applicable as no medical events were reported and no quality defect was confirmed.Despite follow-up attempts, no further information was obtained.

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: 5230927
• MDR Text Key: 31703469
• Report Number: 2951250-2015-01538
• 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,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• 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: 02/05/2016
• 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: 33 YR