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

Model Number ESS305

Device Problems Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616)

Patient Problems Emotional Changes (1831); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Weakness (2145); Cramp(s) (2193); Discomfort (2330); Patient Problem/Medical Problem (2688)

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-0736-1975, awareness date 17-oct-2015).It refers to an adult female consumer of unspecified age in united states who had essure (fallopian tube occlusion insert) inserted in 2014.Consumer was implanted with essure in 2014 and started having issues right away, one of the coils was not inserted properly which caused major pain and discomfort so she was scheduled for a second surgery to have the left tube removed where the coil was inserted improperly.When she woke from surgery they said the coil couldn't be located so they burnt both her tubes instead.After a few months of cramping, severe pelvic pain, discomfort, horrible periods lasting 55 days long, she went to a different doctor for a second opinion.She is (b)(6) and too young to consider having a hysterectomy, so she decided to try the ablation.It has helped her with periods but she still suffers everyday from cramping, severe pelvic pain and discomfort, no sex drive, lack of energy, and random rashes.The coil is somewhere outside of tube in the tissue between tube and uterus by her ovary.Follow-up received on 04-nov-2015: the ptc investigation result was provided.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 investigation 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.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 identified during monitoring of postings on an fda hosted docket website refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced horrible periods lasting 55 days long and an ablation was done.It was reported that one of the coils was not inserted properly.The coil couldn't be located so they burnt both tubes instead.The coil is somewhere outside of tube in the tissue between tube and uterus (seen as device dislocation).A surgery in order to remove left tube was performed.Both events are serious due to their medical importance and listed in the reference safety information for essure.In this case, the exact date and mechanism of device dislocation are not known.Consumer experienced horrible periods a few months after essure insertion.Considering the nature of the events and based on a positive temporal relationship, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident since a surgical intervention was performed.Additionally, non-serious events were reported.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect (no batch number was provided).Medical ptc assessment considered that, based on the available information, there is no relationship between the reported medical 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: 5219868
• MDR Text Key: 31022368
• Report Number: 2951250-2015-01436
• 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
• 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
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention