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

Model Number ESS305

Device Problems Difficult to Insert (1316); Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Hair Loss (1877); Pain (1994); Tissue Damage (2104); Disability (2371); Pregnancy (3193)

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, which took place in september 2015 (fda-2014-n-0736-1150, awareness date 08-oct-2015).It refers to a female consumer of unspecified age in united states who had essure (fallopian tube occlusion insert) inserted in 2008, to prevent pregnancy.Consumer reported that insertion procedure was very painful overall and took 3 hours.She had horrible menstrual cycles following the procedure.She endured debilitating pelvic pain, hair loss and became pregnant and delivered the child.Once discovering she was pregnant at the er (emergency room) (she went because the pain had become unbearable), she requested her medical records and discovered that she had only one coil, the first coil could not be inserted.But yet she was half implanted and told at her dye test confirmation that she was sterile.She had a hysterectomy in 2014 to remove the one coil that was inserted and had migrated into her uterus.Product technical complaint investigation and final assessment were received on 24-oct-2015: 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/ lack of efficacy is excluded.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical events/ lack of efficacy and a quality defect.Company causality comment: this spontaneous non-medically confirmed case report refers to a female consumer who had only one coil of essure (fallopian tube occlusion insert) inserted and became pregnant.She underwent a hysterectomy 6 years after insertion, to remove one coil that migrated into her uterus (interpreted as partial expulsion of device).These events were considered serious due to medical significance and are listed in the reference safety information for essure.During essure 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, one coil had migrated into her uterus.Given the nature of the reported event, causality with essure cannot be excluded.Unintended pregnancies may occur during any contraceptive use, including essure.In the present case, the consumer had only one coil inserted and had a confirmation test stating that she was sterile.The exact reason why the contralateral coil could not be inserted was not specified.The only coil inserted had migrated into her uterus, but it is unknown whether the expulsion occurred before conception.Pregnancy in this case could be considered rather a consequence of the unilateral placement and device expulsion, however given the nature of this event causality with essure cannot be totally excluded.This case was regarded as incident since device removal was required and a hysterectomy was performed.The product technical analysis concluded that based on the available information, there is no relationship between the reported medical events/ lack of efficacy and a quality defect.No active follow-up will be pursued, as this case was identified during health authority website monitoring.

Manufacturer Narrative

Upon internal review on (b)(6) 2016, it was noticed that the (b)(4) is a duplicate of (b)(4).This case will be deleted from bayer database and its content was merged to the remaining (b)(4).

• Brand Name: ESSURE
• Type of Device: KNH - DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas CA 95035
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas CA 95035
• Manufacturer Contact: k. shaw lamberson ; bayer healthcare pharmaceutica; 100 bayer blvd, p o box 915; whippany, NJ 07981-0915
• MDR Report Key: 5200948
• MDR Text Key: 30378672
• Report Number: 2951250-2015-01373
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2016
• 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): Other; Required Intervention