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

Model Number ESS305

Device Problem Separation Failure (2547)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a nurse in (b)(6) on 03-feb-2015 which refers to a female patient of unspecified age who had an attempt of essure (fallopian tube occlusion insert) lot number c12707, insertion.Additional information was received on 04-feb-2015.She informed about a suspicion of defective essure.The applicator did not wind off or discharge.According to her; the physician had push a button but implant did not discharge.Anyway the implant got stuck in patient's tube and the physician had "to work" to get implant off.The implant was managed to be removed and a new implant was inserted.Conclusion was achieved but it took more time and it caused extra pain for the patient.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 there was a suspicion of defective essure, since the implant did not get off or discharge.The implant stuck in patient's tube.Physician had to work to get implant off.The implant was removed and replaced by a new one.Patient experienced extra pain.The reported events, regarded as device deployment issue and procedural complication followed by a difficult essure removal and pain were considered non-serious and are listed in essure's reference safety information.During difficult insertions essure placement may be unsuccessful; in this particular case a product technical analysis will be requested for further evaluation of the reported events; however considering that they occurred in association with essure placement a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident as although the events did not lead to death or serious deterioration in health, it might have led if it occurred under less fortunate circumstances.

Manufacturer Narrative

Ptc investigation result was received on 10-mar-2015.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc global number (b)(4).Final assessment: rollback difficulty is defined as an event in which either the user is (1) unable to perform initial rollback of the thumbwheel due to very high resistance, or (2) able to perform initial rollback of the thumbwheel, but the activity is difficult due to higher than expected level of resistance.Several factors can contribute to a rollback difficulty event.The most likely root causes are a defective thumb wheel or defective catheter rack which prevents the rollback mechanism, inadvertent closure of a hysteroscope valve during the placement procedure which binds up the catheter components and prevents rollback movement, excessive solder material which could prevent components from sliding past each other, a damaged micro-insert which could bind the micro-insert to the outer catheter and prevent catheter movement, or tubal spasms which bind catheter components and temporarily restrict the movement of catheter components.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.We typically inspect the thumbwheel teeth, rack teeth, delivery wire to delivery wire holder solder bond, hypo-tube to handle solder bond, micro-insert condition, and condition of the outer catheter.As received, micro-insert was still intact to delivery catheter.The final rollback was not completed.The thumbwheel appears normal.We were unable to confirm any quality defect or device malfunction at this time.We also conducted a review of the manufacturing batch record and confirmed that final product testing for this lot c12707 (production date 13-jan-2014 and expiration date 31-jan-2017) was performed per requirements and the product met all release requirements.The possibility of a rollback difficulty event during the procedure is an anticipated event.Medical assessment: this ptc was initiated due to a usability issue.The batch documentation of the reported batch was reviewed.The provided complaint sample was investigated.The technical assessment concluded unconfirmed quality defect.The reported adverse event is a known, possible, undesirable event and not indicative of a quality deficit per se.No further ae case reports have been received to date with the referred batch.No batch signal could be identified.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.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 12-mar-2015 for the following meddra preferred term: device deployment issue.The analysis in the global safety database revealed (b)(4) 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 there was a suspicion of defective essure, since the implant did not get off or discharge.The implant stucked in patient's tube.Physician had to work to get implant off.The implant was removed and replaced by a new one.Patient experienced extra pain.The reported events, regarded as device deployment issue and procedural complication followed by a difficult essure removal and pain were considered non-serious and are listed in essure's reference safety information.During difficult insertions essure placement may be unsuccessful; considering the reported events occurred in association with essure placement a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident, as although there was no death or serious deterioration in patient's health, this might have led if it occurred under less fortunate circumstances.A product technical analysis (ptc) was performed with an investigation of the actual device involved in this complaint.As received, micro-insert was still intact to delivery catheter.Ptc was unable to confirm any quality defect or device malfunction and concluded there is no reason to suspect a casual relationship to a potential quality deficit based on this report.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: 4572618
• MDR Text Key: 5460830
• Report Number: 2951250-2015-00157
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: ESS305
• Device Lot Number: C12707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2014
• 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