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

Model Number ESS305

Device Problems Sticking (1597); Separation Failure (2547)

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 20-nov-2014 which refers to a (b)(6) female patient who had an attempt to insert essure (fallopian tube occlusion insert) lot number c38210 on (b)(6) 2014.Number of defective unit: one.Operatory report from the gynecologist from (b)(6) 2014: perineal and vaginal disinfection.Introduction of the hysteroscope under a stream of physiological saline heated by vaginoscopy, without speculum.Cavity of normal aspect, no visible lesion.Mucous of normal aspect.Easy catheterization of the left ostium, but difficulty turning the deployment wheel not allowing to activate the release button of the implant.No other possibility of release.Stop of the procedure.Attempt of total withdrawal impossible inspite of gripping clamp.Implant cut at the entry of the cervix.Remaining part to the uterine level.No attempt to the right.Operatory followings: normal, no bleeding, no pain.Discharge: on the same day, with convocation for laparoscopic exploration with removal of the implants and tubal sterilization.No further information was provided.Ptc investigation result was received on (b)(6) 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: lot number c38210 (production date 19-mar-2014 and expiration date 31-mar-2017).Detachment difficulty is defined as a failure of the micro-insert to detach (separate) from the delivery system.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper detachment: rollback to initial hard stop.Depress button.Perform final rollback.Under normal circumstances, when the physician completes all deployment steps as outlined in the ifu, the micro-insert assembly will detach from the delivery wire and remain in the fallopian tube.Several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the insert's grip on the delivery wire, and potential manufacturing deficiencies.As of 11/26/2014, 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, the outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all are within manufacturing specifications.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.The possibility of a detachment difficulty event and the possibility of pieces of the delivery system or micro-insert breaking off during the procedure are anticipated events.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 the design fmea.According to the dfmea, the most likely consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Medical assessment: this ptc was initiated due to a product issue.The ae case refers also to usability issues.No adverse events were reported at this point in time.The batch documentation of the reported batch was reviewed.No complaint sample was provided for a technical investigation.The technical assessment concluded "unconfirmed quality defect".At this point in time no adverse events have been reported; therefore a batch investigation with regard to similar ae cases is not applicable.In summary, based on the available information there is no reason to suspect a causal relationship to a potential quality deficit as no defect was confirmed and no adverse events were reported.Follow-up received on 02-feb-2015.Product technical complaint investigation and final assessment were updated: (b)(4).Final assessment: lot number: c38210; expiration date: 31-mar-2017; production date: 19-mar-2014.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 micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly.As received, micro-inert found to be broken and detached.The final rollback was not completed.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 was performed per requirements and the product met all release requirements.The possibility of a detachment difficulty event and broken implant during the procedure are anticipated events.Medical assessment: this ptc was initiated due to a product quality issue.In addition, the ae case refers to a usability issue.However, no adverse events were reported.The batch documentation of the reported batch was reviewed.The returned complaint sample was investigated.The technical assessment concluded unconfirmed quality defect.Since no adverse events have been reported a batch investigation with regard to similar ae cases is not applicable.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 (b)(4).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-feb-2015 for the following (b)(4) preferred term: device breakage.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 to insert essure (fallopian tube occlusion insert) and according to product technical analysis, micro-inert found to be broken and detached.This event, considered as device breakage, is non-serious and listed for essure based on the product technical analysis (ptc) received which stated that the possibility of a detachment difficulty event and broken implant during the procedure are anticipated events.During difficult insertion/removals, single cases have been reported of essure breakage.As the breakage occurred during essure placement procedure, a causal relationship between this event and 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.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.No further information is expected.

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: 4562816
• MDR Text Key: 5474313
• Report Number: 2951250-2015-00153
• 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: Pharmacist
• 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: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: ESS305
• Device Lot Number: C38210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR