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

Model Number ESS305

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in (b)(6) on (b)(6) 2014 which refers to (b)(6)-year-old female patient who had an attempt to have essure (fallopian tube occlusion insert) inserted on (b)(6) 2014, lot number c26937.No anesthesia had been performed for essure placement procedure.Procedure had been started on right side and was interrupted as implant did not release.Physician had to cut implant with scissors at uterine horn level as complete removal was impossible.No hemorrhagic or painful complication.Physician reported that the two ostia uterina and uterine cavity had no lesion.The placement of a subcutaneous implant was suggested to the patient in outpatient setting.No further information will be provided.Case closed ptc investigation result was received on 09-oct-2014.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: usability issues (uis) are not associated with technical defects or adverse events.Uis are typically acts that lead to a different result than expected by the user.Examples include, but are not limited to, handling errors, deviations from the instructions for use, non- product related anatomical issues, or other customer satisfaction issues.Medical assessment: this ptc was initiated due to usability issues.No adverse events were reported at this point in time.The technical assessment concluded "unconfirmed quality defect" and a handling error.No complaint sample was provided for lot number c26937 (production date 19-feb-2014 and expiration date 28-feb-2017) for further investigation.Since no adverse events were reported no batch signal review for similar adverse events could be conducted.No causal relationship between the confirmed product quality issue and adverse events can be assessed, as no adverse events were reported at this point in time.The reported usability issues will be subject to post market surveillance monitoring.The list of similar cases contains reports with similar events coded in meddra.It includes recent cases received by bayer pharma and older cases received from the previous owner of the essure product (conceptus).These legacy reports have been re-coded according to bayer pharma standards.In this particular case a search in the database was performed on (b)(6) 2014 for the following meddra preferred terms: 1.Device deployment issue.The analysis in the global safety database revealed 283 cases.2.Device difficult to use.The analysis in the global safety database revealed 260 cases.Bayer is closely monitoring the benefit-risk profile of essure.This includes consideration of the legacy cases in safety analyses.The cumulative review of the reports has not yielded any new safety signal." company causality comment: this spontaneous case report refers to a (b)(6) year-old female patient who had an attempt to have essure (fallopian tube occlusion insert) inserted and essure implant did not release, procedure was interrupted, necessity to cut implant with scissors at uterine horn level and complete removal was impossible.These events are non-serious and listed according to the reference safety information for essure.This case was regarded as other reportable incident due to the reported malfunction.In the present case, insertion procedure was interrupted as implant was not released.The reporter stated that there was the necessity to cut implant with scissors at uterine horn level as complete removal was impossible.Given the nature of the reported events they were considered as related to essure except for necessity to cut implant with scissors at uterine horn level (interpreted as a device misuse) which was considered unrelated.A product technical analysis was performed and concluded to unconfirmed quality defect (no complaint sample was provided) and a handling error.No further information is expected.

Manufacturer Narrative

Data correction: the product 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: 4169028
• MDR Text Key: 18295102
• Report Number: 2951250-2014-00427
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: ESS305
• Device Lot Number: C26937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR