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

Model Number ESS305

Device Problems Break (1069); Patient-Device Incompatibility (2682); Expulsion (2933)

Patient Problems Bruise/Contusion (1754); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Miscarriage (1962); Rash (2033); Disability (2371)

Event Type  Injury  

Event Description

This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting taking place in september 2015 (case# fda-2014-n-0736-0794, awareness date 27-aug-2015).It refers to a (b)(6) female consumer in united states who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2011.Additional information received on 14-sep-2015 (ptc - product technical complaint - was received).Her doctor told her at time of procedure that essure was made of plastic and could be removed whenever she wanted.She found out after insertion that essure are made from nickel and doctor knew that she was allergic to nickel.Consumer stated that in (b)(6) 2011 it was confirmed that tubes were blocked.She had 109 side effects from essure.Her left coil was broken, she was losing hair, breaking out everywhere, had unexplained bruising and expelled pet fibers.In (b)(6) 2015, she had a miscarriage from essure and her husband and she are currently waiting to find out if she is pregnant again (case (b)(4)).She is mother of 4 kids (2 of her and 2 of her husband) and she could not do simples things because of the pain.Ptc investigation result.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 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.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.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.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: no product quality defect was confirmed therefore a relationship to the reported medical events and lack of efficacy is excluded.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical events/lack of efficacy and a quality defect.Company causality comment: this non-medically confirmed, spontaneous case report identified during monitoring of postings on an fda hosted docket website refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and her left coil was broken and expelled pet fibers.She got pregnant and had a miscarriage.All events, except miscarriage, are listed in the reference safety information for essure.Device breakage is listed upon receipt of the product technical analysis.The events pregnancy and miscarriage are serious due to their medical importance while the other events are non-serious.In this case, it was not reported whether left coil was broken during essure insertion procedure.Consumer had a miscarriage about 4 years and 1 month after essure insertion.Considering that a mechanical interference of essure micro-inserts in early developing pregnancy is unlikely, the event miscarriage was considered as unrelated to the insert.With regards to the other events, given their nature, a causal relationship with suspect insert cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Additionally, non-serious events were reported.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no relationship between the reported medical events/lack of efficacy and a quality defect.No active follow-up will be pursued, as this case was identified during health authority website monitoring.

• 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: 5097216
• MDR Text Key: 26541344
• Report Number: 2951250-2015-01058
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• 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
• Date Manufacturer Received: 08/27/2015
• 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
• Patient Age: 28 YR