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

Model Number ESS305

Device Problems Break (1069); Difficult to Insert (1316); Folded (2630); Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Hair Loss (1877); Menstrual Irregularities (1959); Discomfort (2330); Irritability (2421); Sleep Dysfunction (2517); Weight Changes (2607); Heavier Menses (2666)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a consumer of unspecified age via regulatory authority (case# mw5057635) in united states on 16-nov-2015 who had essure (fallopian tube occlusion insert) inserted.Essure procedure went horrible, during insertion she was told her uterus was tilted and the doctor could not get to her right tube.She stated that then she endured about what felt like an eternity of scraping of the lining of her uterus as he tried to locate the second tube because of the saline that they use has absorbed into the lining making it impossible to locate the tube.She never had the second essure implanted because of the inability to find the fallopian tube.A few months after she had essure implanted, she was diagnosed with lupus.She also had endured hair loss, mood swings, heavy periods that make working impossible, excessive clotting during her period, inability to sleep, weight gain, irregular periods, to list a few.She also felt a small twinge of pain where she was assuming the essure is located on her left side.She also had an x-ray done and the essure that she has, was almost folded in half and it looked like a piece of it was not connected.She was not told that people with compromised immune systems or nickel allergies did not make good candidates and also, was never told of pet fibers that were part of the coil.The consumer mentioned the event outcome disability/permanent damage but not specified and/or assigned to one of the events.Company causality comment: this spontaneous non-medically confirmed case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and was diagnosed with lupus.She also had an x-ray which showed that essure is almost folded in half and it looks like a piece of it is not connected (interpreted as device breakage).These events are unlisted in the reference safety information for essure.Lupus is a chronic inflammatory disease that follows a relapsing and remitting course.Majority of cases occur in women, frequently starting at childbearing age.Given the pathophysiology of lupus and considering the local effect of essure in the fallopian tubes, causality was assessed as unrelated.The exact date and mechanism of the device breakage in this case was not reported.However, given the nature of this event, causality with essure cannot be excluded.Additional non-serious events were reported.This case was regarded as other reportable incident as although the device breakage did not lead to death or serious deterioration in health, this might have occurred under less fortunate circumstances.A product technical analysis and further information are expected.

Manufacturer Narrative

Ptc investigation result was received on 29-dec-2015.This adverse event report is related to a product technical complaint (ptc).(b)(4).Final assessment: 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 are unable to confirm any quality defect or device malfunction at this time.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, therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.The reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar adverse event cases is not applicable.Follow-up from 13-jan-2016: follow-up attempts were done with no response to date.Company causality comment: this spontaneous non-medically confirmed case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and was diagnosed with lupus.She also had an x-ray which showed that essure is almost folded in half and it looks like a piece of it is not connected (interpreted as device breakage).Lupus is unlisted in the reference safety information for essure, device breakage is anticipated according to the technical analysis.Lupus is a chronic inflammatory disease that follows a relapsing and remitting course.Majority of cases occur in women, frequently starting at childbearing age.Given the pathophysiology of lupus and considering the local effect of essure in the fallopian tubes, causality was assessed as unrelated.The exact date and mechanism of the device breakage in this case was not reported.However, given the nature of this event, causality with essure cannot be excluded.Additional non-serious events were reported.This case was regarded as other reportable incident as although the device breakage did not lead to death or serious deterioration in health, this might have occurred under less fortunate circumstances.According to product technical analysis, since no batch number was reported, a batch investigation with respect to similar adverse event cases is not applicable.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: 5298797
• MDR Text Key: 34301385
• Report Number: 2951250-2015-01913
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2017

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?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2016; 01/20/2017
• 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