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

Model Number ESS305

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Headache (1880); Pain (1994); Pregnancy (3193)

Event Type  malfunction  

Event Description

This spontaneous case report was posted online by a consumer referring to herself on 07-mar-2014 in a united states social media plataform describing migraines attributed to use of essure (fallopian tube occlusion insert).Follow-up information received on 12-mar-2014: new reporter added.Follow up information received on 30-jun-2014: no new information.Follow-up information received from consumer on 14-jan-2015: the consumer stated that she had a baby after essure.Follow-up received on 01-feb-2015.Product technical complaint investigation and final assessment were received: this adverse event report is related to a product technical complaint and was initiated due to a lack of efficacy.The bayer reference number for the ptc report is (b)(4).Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.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.No new failure mode has been identified.Medical assessment: this ptc was initiated due to a lack of efficacy.Contraceptive failure may occur under the use of any contraceptive and is not indicative of a quality defect per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample was available for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up information received on 08-sep-2015: consumer stated that she still got pregnant.Follow-up information received on 05-nov-2015.No new clinical information received.Follow-up information received on 22-dec-2015 via social media: consumer reported coil migrated, fragments, e baby, surgeries and pain.Updated ptc investigation result was received on 13-jan-2016.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc global number (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.The reported medical events and lack of efficacy are 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.In summary, there is no reason to suspect a causal relationship between the reported medical events or lack of efficacy and a quality defect.Company causality comment: this spontaneous non-medically confirmed case report received from social medial refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and had a baby after essure (device ineffective).She also mentioned coil migrated (interpreted as device dislocation), fragments (interpreted as device breakage) and surgeries.Device breakage is anticipated according to the technical analysis.Surgeries is unlisted in the reference safety information for essure, while the other events are listed.In the present case, no information was provided regarding the time interval between essure insertion and the pregnancy or whether the consumer had a confirmation test or not.However, given the nature of this event a causal relationship with essure cannot be excluded.Regarding event coil migrated, the exact location of the device was not reported.Despite the limited information provided, given the nature of this event, causality with essure cannot be excluded.Limited information was provided regarding the fragments.The exact date and mechanism of this breakage were not reported.However, given the nature of this event, causality with the suspect insert cannot be excluded.Consumer mentioned surgeries.The exact nature and indication for these surgeries were not specified.Due to the lack of comprehensive medical information for proper assessment of the event, a causal relationship between surgeries and the suspect device cannot be assessed.Since a device breakage was reported this case was upgraded to 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.Based on the available information no product quality defect was confirmed.The reported medical events and lack of efficacy are and not indicative of a quality deficit per se.No follow-up will be pursued since no contact information was provided (social media case).

Manufacturer Narrative

Data correction: the product 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: 5379162
• MDR Text Key: 36949131
• Report Number: 2951250-2016-00032
• 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
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• 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
• Date Manufacturer Received: 12/22/2015
• 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