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

Model Number ESS305

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Tissue Damage (2104); Test Result (2695); Pregnancy (3193)

Event Date 10/01/2010

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in united states on 03-aug-2015 and refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2010 for contraception.In (b)(6) 2010, hysterosalpingogram (hsg) was performed and showed occlusion on the right side.Left side, the device was not present and spillage was noted.Became pregnant in 2014, delivered a baby the end of (b)(6) 2015 (healthy).In (b)(6) 2015, a salpingectomy was performed with the intent of removing the devices and tying the tubes.Not able to locate either device.X-ray showed devices in pelvis.The patient had no complaints.She wants them out.Treatment plan is to be determined.Follow-up information received on 05-aug-2015 physician would like to know implications of leaving the essure in the pelvis or it there is a recommendation of removal.Salpingectomy was performed and essure devices were not located.Hysteroscopy also performed and essure devices not located.X-ray showed devices not in correct location.Follow-up received on 14-aug-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 (pregnancy).The bayer reference number for the ptc report is (b)(4) and the local number 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.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a lack of efficacy.A contraceptive failure may occur with the use of any contraceptive and is not indicative of a quality deficit per se.Neither batch number nor complaint sample was available for a technical investigation.The technical assessment concluded unconfirmed quality defect.The reported adverse events are known, possible, undesirable events and not indicative of a quality deficit 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.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and hysterosalpingogram (hsg) performed 4 months later showed left side the device was not present.She got pregnant more than 3 years after insertion and the baby was born healthy.Two months after delivery she underwent a salpingectomy with the intent of removing the devices and tying the tubes but the devices were not located and an x-ray showed devices in pelvis.These events are serious due to medical significance and listed in the reference safety information for essure.Event left side the device was not present/ devices in pelvis was interpreted as device dislocation into pelvic cavity.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or dislocation (distal fallopian tube or peritoneal cavity).In the present case the dislocation was diagnosed 4 months after insertion.Given the nature of this event, causality with essure cannot be excluded.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Some of these pregnancies occurred due to patient non-compliance which included failure to return for the essure confirmation test to determine if the inserts are in the correct location and tubal occlusion is present.In the present case the hsg showed left device was not present and spillage was noted.It was not reported whether the patient used any form of alternative contraception.The device dislocation might explain the occurrence of pregnancy, however given the nature of this event, causality with essure cannot be excluded.This case was regarded as incident due to required intervention.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.Further information has been requested.

Manufacturer Narrative

Follow up information received on (b)(4) 2015: follow-up attempts were done with no response to date.

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: 5034939
• MDR Text Key: 24275019
• Report Number: 2951250-2015-00654
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: 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?: 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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/04/2015; 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
• Patient Outcome(s): Other; Required Intervention