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

Model Number ESS305

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

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 (b)(6) 2015 (case # fda-2015-n-2781-0536, awareness date 14-aug-2015 ).It was received from a female consumer of unspecified age in united states who had essure (fallopian tube occlusion insert) inserted on an unspecified date for birth control.This case refers to consumer's fetus.Consumer reported she had a stillbirth at 4 months pregnancy.For mother's case please refer to case: (b)(4).Company causality comment: this non-medically confirmed, spontaneous case report was received from a female consumer and refers to her fetus; who was exposed to essure (fallopian tube occlusion insert) in uterus.The mother gave birth to the stillborn at (b)(6) months pregnant.The reported event is unlisted according to essure's reference safety information.In this particular case, limited information was provided.Neither the complications experienced by the mother nor fetus status were specified.Nevertheless, considering the event occurred during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded and the reported death was, thus considered as related to the suspect insert.This case was considered an incident, due to fetal death.A product technical analysis is being sought.No active follow-up will be pursued, as this case was identified during health authority website monitoring.

Manufacturer Narrative

Product technical complaint (ptc) investigation result received on 22-mar-2016: (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: based on the available information, there is no relationship between the reported events and a quality defect.Company causality comment: this non-medically confirmed, spontaneous case report was received from a female consumer and refers to her fetus; who was exposed to essure (fallopian tube occlusion insert) in uterus.The mother gave birth to the stillborn at (b)(6) pregnant.The reported event is unlisted according to essure's reference safety information.In this particular case, limited information was provided.Neither the complications experienced by the mother nor fetus status were specified.Nevertheless, considering the event occurred during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded and the reported death was, thus considered as related to the suspect insert.This case was considered an incident, due to fetal death.Based on the available information, there is no relationship between the reported events and a quality defect.No active follow-up will be pursued, as this case was identified during health authority website monitoring.

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: 5073517
• MDR Text Key: 25626713
• Report Number: 2951250-2015-00922
• 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: Initial,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2016
• 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): Death