MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Menstrual Irregularities (1959); Pain (1994); Rash (2033); Intermenstrual Bleeding (2665)

Event Date 01/01/2014

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 september 2015 (case# fda-2014-n-0736-0673, awareness date 18-aug-2015).It refers to a female consumer of unspecified age in finland who had essure (fallopian tube occlusion insert) inserted in 2014.Consumer had essure procedure done and has been sick ever since (little over a year prior to this report).She suffers from irregular menstrual cycle - bleeding for 5 days, every 1,5-2 weeks; bleeding and pain after sex; pelvic, lower back and groin pain; skin rashes, pimples and hair growth.She has now been put on line for a hysterectomy, but due to being so sick she lost her job.Follow-up from 16-sep-2015: upon request from regulatory authority the case was upgraded to incident.Product technical complaint (ptc) investigation result was received on 09-oct-2015: 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: no product quality defect was confirmed therefore a relationship to the reported medical events is excluded.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical events and a quality defect.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(6) 2015 for the following meddra preferred term: menstruation irregular.The analysis in the global safety database revealed (b)(4).Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Company causality comment: this spontaneous not medically confirmed case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and since then had irregular menstrual cycle (bleeding for 5 days, every 1,5-2 weeks).This event was considered serious due to medical significance and is listed in the reference safety information for essure.Abnormal genital bleeding and menses pattern changes may occur after essure insertion.Given the positive temporal relationship and in the lack of an alternative explanation, a causal relationship between essure and event irregular menstrual cycle cannot be excluded.Non-serious events were also reported.This case was initially regarded as non-incident; since no intervention or hospitalization had been confirmed at the time of this report.However, upon health authority (ha) request it was upgraded to incident (in line with ha assessment).The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical events and a quality defect.

• Brand Name: ESSURE
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd.; milpitas CA 95035
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd., p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5152614
• MDR Text Key: 28371510
• Report Number: 2951250-2015-01188
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• 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: 09/16/2015
• 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
• Patient Outcome(s): Other