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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This spontaneous case was reported by a non-health professional and describes the occurrence of medical device removal ("butchered and pieces of metal had been left in their bodies") in na unknown number female patients who received essure.The occurrence of additional non-serious events is detailed below.On an unknown date, the patients started essure.On an unknown date, the patients experienced medical device removal (serious criteria medically significant and clinically significant/intervention required), device breakage ("butchered and pieces of metal had been left in their bodies") and complication of device removal ("pieces of metal had been left in their bodies").At the time of the report, the medical device removal, device breakage and complication of device removal outcomes were unknown.The reporter provided no causality assessment for medical device removal, device breakage and complication of device removal with essure.Company causality comment: this spontaneous case report refers to an unspecified number of consumers who had essure inserted and stated that they were butchered and pieces of metal had been left in their bodies.This event was seen as a device removal due an unspecified reason, a device breakage, and also a complication of device removal.All these events are anticipated in the reference safety information for essure.This case was reported with very limited information.Neither reason for device removal nor time point of removal and breakage was reported.All reported events may occur during essure use and thus, despite the lack of essential information, company conservatively assesses all events as related.This case was regarded as incident since device removal was required.No further information is expected from consumers.A product technical analysis is being sought.

Manufacturer Narrative

Quality-safety evaluation of ptc: 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 in growth.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.Sample not available.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 of catheter and micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode.Base on the provided information the defect type corresponds to the following meddra llt: device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical event is a known possible undesirable event and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 17-feb-2017: quality-safety evaluation of product technical complaint was received.Company causality comment: this spontaneous case report refers to an unspecified number of consumers who had essure inserted and stated that they were butchered and pieces of metal had been left in their bodies.This event was seen as a device removal due an unspecified reason, a device breakage, and also a complication of device removal.All these events are anticipated in the reference safety information for essure.This case was reported with very limited information.Neither reason for device removal nor time point of removal and breakage was reported.All reported events may occur during essure use and thus, despite the lack of essential information, company conservatively assesses all events as related.This case was regarded as incident since device removal was required.According to the product technical analysis, a product quality defect could not be confirmed but is considered plausible.No further information is expected from consumers.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd. p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6236608
• MDR Text Key: 64279504
• Report Number: 2951250-2017-00126
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 02/17/2017
• 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 Outcome(s): Other; Required Intervention