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); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Uterine Perforation (2121); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a female consumer of unspecified age via regulatory authority fda maude (case# (b)(4)) in united states on 22-oct-2015.It refers to herself who had essure (fallopian tube occlusion insert) inserted.Consumer had to have a hysterectomy done 5 days ago ((b)(6) 2015), because her essure coils moved, making her have severe pain and bleed; shreads of nickel and pet fibers were found in her uterus.She is now off work for 2 months and suffering.Concomitant medications include cipro, adiphex, dulexis and alprazolam.The seriousness criteria hospitalization and disability were mentioned in the section event outcome but they were not specified and/or mentioned to one of the events in the narrative.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had a hysterectomy because essure (fallopian tube occlusion insert) coils moved.She stated shreads of nickel and pet fibers were found in her uterus (regarded as device breakage).Only device breakage is unlisted according to essure's reference safety information.During essure micro-insert therapy there is a risk that the device could move in/out of fallopian tubes; this movement could be an expulsion, dislocation or occur as a result of a uterine/fallopian tube perforation.In this case limited information was provided.Nevertheless; given events nature; causality with the suspect device cannot be excluded.This case was regarded as incident since device removal was required (hysterectomy performed) a product technical analysis and follow-up information are being sought.

Manufacturer Narrative

Product technical complaint (ptc) investigation result received on 12-nov-2015: this adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: (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 reported medical events are not indicative of a quality deficit per se.A review of similar cases is not applicable as no batch number was reported.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.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had a hysterectomy because essure (fallopian tube occlusion insert) coils moved.She stated threads of nickel and pet fibers were found in her uterus (regarded as device breakage).Device breakage is anticipated according to the technical analysis, while the reported device movement is listed in essure's reference safety information.During essure micro-insert therapy there is a risk that the device could move in/out of fallopian tubes; this movement could be an expulsion, dislocation or occur as a result of a uterine/fallopian tube perforation.In this case limited information was provided.Nevertheless; given events nature; causality with the suspect device cannot be excluded.This case was regarded as incident since device removal was required (hysterectomy performed).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.Follow-up information is being sought.

Manufacturer Narrative

Follow-up information received on 18-dec-2015: attempts of follow-up were made with no response to date.Case closed.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had a hysterectomy because essure (fallopian tube occlusion insert) coils moved.She stated shreads of nickel and pet fibers were found in her uterus (regarded as device breakage).Device breakage is anticipated according to the technical analysis, while the reported device movement is listed in essure's reference safety information.During essure micro-insert therapy there is a risk that the device could move in/out of fallopian tubes; this movement could be an expulsion, dislocation or occur as a result of a uterine/fallopian tube perforation.In this case limited information was provided.Nevertheless; given events nature; causality with the suspect device cannot be excluded.This case was regarded as incident since device removal was required (hysterectomy performed) 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.No further information is expected.

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: 5230542
• MDR Text Key: 31447596
• Report Number: 2951250-2015-01548
• 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,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?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/07/2015; 01/15/2016; 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): Hospitalization; Other; Required Intervention; Disability