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

Model Number ESS205

Device Problems Break (1069); Kinked (1339); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

This solicited case report from a consumer in the united states was detected on (b)(6) 2014 via essure generic active online listening.The report refers to the reporting female consumer of unspecified age who had essure (ess205) (fallopian tube occlusion insert) inserted and provided a photo showing two essure coils with device shape alteration and device breakage of left coil.Consumer stated it nearly killed her.No information was given on consumer's history, past drugs, concomitant medication and concurrent conditions.On an unspecified date, the consumer had essure (ess205) (fallopian tube occlusion insert) inserted for birth control.Consumer provided a photo showing two explanted essure coils with device shape alteration and device breakage of left coil.Consumer asked whether this looked like something that should last a lifetime, and stated no, it lasted seven years and nearly killed her.No further details were reported and can be obtained.Follow-up 20-feb-2014 and 25-feb-2014: consumer reported her case in the social media in the internet.On (b)(6) 2014, consumer reported that she is growing a pair (not otherwise specified) and is telling her entire story in that week.Consumer stated essure causes cancer and the fda knew it.On (b)(6) 2014, consumer again reported that essure almost killed her.No further details were reported.Follow up information received on 19-mar-2014: new reporter was added.The consumer stated essure was crumbling inside her.Follow up information received on 10-dec-2014: a picture of two essure coils broken and kinked was provided.The consumer stated that essure almost killed her.Case upgraded to incident.Ptc (product technical complaint) investigation result received on 19-dec-2014.The ptc global number for this 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.Possible essure device removal was identified as an anticipated event during the design process.Medical assessment: this ptc was initiated due to a product quality issue.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect.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.The reported adverse event is a known, possible, undesirable event and not indicative of a quality deficit per se.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up received on 31-dec-2014: consumer contact information unavailable.Case closed.Company causality comment: this non-medically confirmed solicited case report refers to a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted and essure was removed.After the procedure, the devices were found broken and with device shape alteration in a picture provided.The first event is serious due medical importance and the others are non-serious.All events are listed in the reference safety information for essure, except the breakage which is unlisted.In this case, very limited information was informed.A picture of the devices was provided with two coils.The photo presented two micro-inserts with device shape alteration and device breakage.An intervention was implied, since the pictures showed surgical material and a surgery is necessary to remove the micro-inserts.The circumstances and mechanism of breakage and the reason of the removal are not known.However, given the nature of the events, causality is assessed as related to essure.Initially, the case was regarded as non-incident.Upon receipt of follow up information, the material of the new picture was interpreted as a product of a surgical procedure, therefore an intervention required was implied and the case was upgraded to incident.The technical analysis concluded unconfirmed quality defect.There is no reason to suspect a causal relationship to a potential quality deficit.No follow up was possible since consumer contact information was unavailable.

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: 4386170
• MDR Text Key: 16304699
• Report Number: 2951250-2015-00009
• 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: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention