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

Model Number ESS305

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a pharmacist in (b)(6) on (b)(6) 2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert), lot number c26939, inserted.Reporter states that an anomaly on one essure insert was observed in the operating room during the placement.According to health care professional there was problem of catheterization of the fallopian tubes with damage of the coils of the essure insert.Bilateral placement was performed with another essure system.No further information available at the time of this report.Ptc investigation result was received on (b)(6) 2014.This adverse event report is related to a product technical complaint (ptc).(b)(4).Final assessment: as of 9/9/2014, 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 to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.Medical assessment: in this particular case, a technical defect (damage) was reported together with a usability issue.No adverse events were reported at this point in time.No complaint sample was provide.The technical assessment concluded "unconfirmed quality defect" (see technical assessment).No further ae case reports have been received to date in relation to batch no.C26939 (production date 20-feb-2014 and expiration date 28-feb-2017).No causal relationship between the reported technical defect and adverse events can be assessed as no adverse events were reported.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted and during the procedure essure damaged.The event essure damaged was considered as non-serious and is unlisted for essure according to the reference safety information.In this particular case, it was not reported the exact alteration of the essure.A technical investigation of the affected essure and review of the batch records is necessary to determine the reason for device damage.Based on the information received, a causal relationship between the event and suspect insert cannot be excluded.This case was regarded as other reportable incident due to the reported device damage (since the event could lead to serious injury).Additionally, non-serious event was reported: problem of catheterization of the fallopian tubes.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that no causal relationship between the reported technical defect and adverse events can be assessed as no adverse events were reported.Further information is being sought.

Manufacturer Narrative

Additional information from ptc assessment: final assessment: this is an anticipated failure mode.The risk to the patient for this failure mode was assessed during the design process, and adequate risk mitigation actions were taken to minimize the residual risk as documented in (b)(4), design fmea for ess305.Follow-up from (b)(6) 2015: no further information obtained despite fu attempts.Case closed.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 term: device damage.The analysis in the global safety database revealed 2 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 medically confirmed, spontaneous case report refers to a female patient who had an attempt of essure (fallopian tube occlusion insert) insertion and during the procedure essure damaged.This event was considered non-serious and regarded as listed (anticipated) according to the product technical analysis (ptc) results.In this particular case, although the exact alteration of essure was not provided, since the reported event occurred in association with essure placement procedure, a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to the reported device damage (since the event could lead to serious injury).The ptc analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that no causal relationship between the reported technical defect and adverse events can be assessed as no adverse events were reported.No further information could be obtained despite follow-up attempts.

• Brand Name: ESSURE
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd.; milpitas CA 95035
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd., p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 4124846
• MDR Text Key: 4939141
• Report Number: 2951250-2014-00402
• Device Sequence Number: 1
• Product Code: KNH
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• 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: C26939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1