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

Model Number ESS305

Device Problem Break (1069)

Patient Problems Miscarriage (1962); Pregnancy (3193)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a female consumer of unspecified age in united states on 20-jul-2015 who had essure (fallopian tube occlusion insert) inserted on an unspecified date.Consumer stated that essure broke inside of her and she became pregnant (device ineffective) and miscarried.She wants to remove essure.Ptc investigation result was received on 03-aug-2015.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc local number (b)(4) and ptc global number (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, outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all parts are accounted for.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.The possibility of the micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a product technical issue and a lack of efficacy.A contraceptive failure may occur with the use of any contraceptive and is not indicative of a quality deficit per se.Neither batch number nor complaint sample was available for a technical investigation.The technical assessment concluded unconfirmed quality defect.The reported adverse event considered related is a known, possible, undesirable event and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and stated that essure broke inside of her and she became pregnant and miscarried.Pregnancy and miscarriage are serious due to medical importance and listed in the reference safety information for essure while device breakage is non-serious and was considered listed upon receipt of the product technical analysis.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Therefore a causal relationship between the suspect insert and the reported pregnancy cannot be excluded.Regarding miscarriage (spontaneous abortion), it is the most common complication of early human pregnancy, occurring mainly during the first trimester of pregnancy.This is considered to be due to a high number of abnormal embryos presenting with either chromosomal and/or gross morphological abnormalities.Considering that a mechanical interference of essure micro-inserts in early developing pregnancy is unlikely, a causal relationship with suspect insert can be excluded.During difficult insertion/removals, single cases have been reported of essure breakage.Although it was not reported when device breakage occurred, a causal relationship with suspect insert cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.

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: 5007434
• MDR Text Key: 23134820
• Report Number: 2951250-2015-00608
• 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: 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: Not provided
• Initial Date FDA Received: 08/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 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): Other