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

Model Number ESS305

Device Problems Break (1069); Mechanical Problem (1384); Difficult to Remove (1528)

Patient Problems Tissue Damage (2104); Insufficient Information (4580)

Event Date 04/07/2014

Event Type  Injury  

Event Description

This is a spontaneous cae report received from a gynecologist/obstetrician in (b)(6) on (b)(6) 2014 which refers to a female pt of unspecified age who had an attempt of essure (fallopian tube occlusion insert) insertion and it was impossible to release the device: broken catheter and impossible withdrawal and the delivery was not bilateral.No info given on pt's history, past drugs, concurrent conditions or concomitant medication.On (b)(6) 2014 the pt had an attempt of essure (fallopian tube occlusion insert) insertion, lot number 50750351.The reporter stated that, although conditions of the placement were excellent, during device placement the coils device was not released and it was impossible to remove the catheter (broken catheter and impossible withdrawal).The delivery was not bilateral and a celioscopy to remove device was required.The device was kept in the hospital.The criterion of seriousness was by the reporter as a serious risk.

Manufacturer Narrative

Ptc investigation result received on 05/22/2014 ptc global number: 2014-009955.Final assessment: lot history record (lhr) reviewed.Product met product release specs.As of 04/23/2014, no device was returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: this case reported complication of device insertion due to deployment issue of being impossible to release device and withdraw catheter (became broken) resulting in failed bilateral insertion.The events reported are not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.One (1) add'l ae case report has been received to date in relation to batch number 50750351 which refers to similar type of events.No unusual pattern can be identified at this time.The review of the lot history records confirmed that the product met product release specs.At the time of this medical assessment, the technical investigation concluded "unconfirmed quality defect".Based on the info available, there is no reason to suspect a quality defect.F/u received on 05/23/2014; according to the pharmacist, the pt was doing well.The pharmacist had no return that it had gone wrong.On (b)(6) 2014, celioscopy was done.The pharmacist was to try to have more info (call back later to confirm).Case to be closed.Follow-up information was received on 16-jun-2014: duplicated case was found and all the information from the deleted case 2014-079755 - bfr- 2014-fr-001665 was transferred to this case.Local health authority was added as reporter.Product technical complaint investigation and final assessment were received on 24-jun-2014: the bayer reference number for the ptc report is: 2014-013251.Final assessment when a term like "broken" is used when describing a device event, it is difficult to determine the true nature of the event from the complaint description alone.Unless additional detail is provided in the event description, it is difficult to determine if the reporter is describing an event where the micro-insert actually broke into individual pieces, if the micro-insert bent or stretched into an unintended shape, and hence was considered by the reporter to be "broken", or if a different portion of the delivery catheter was broken off inside the patient.Failure mode/mechanism: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The insert's outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If the outer coils of the micro-insert partially deploy during user attempts to repositioning the device and the coil catheter is not fully retracted, the outer coils of the micro-insert could become entangled within the distal portion of the coil catheter.If the outer coils are partially deployed, the insert will begin to anchor itself to the fallopian tube.If the inner coil is still affixed to the delivery wire because all ifu steps have not yet been completed, subsequent attempts by the user to remove the catheter assembly may lead to either a stretching of the microinsert, stretching of the inner catheter large tight pitch coil, or breakage of the large tight pitch coil.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the microinsert with a grasper, this action could also lead to breakage of the outer coil of the microinsert.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.Since neither product was returned for inspection nor do we have a photograph of the actual device, we cannot determine exactly what the failure is.Based on our experience with device complaints of a similar nature, it is likely the reporter is referring to an event in which the microinsert was bent or stretched into a shape which rendered the device to be unusable, and hence, "broken." since no product was returned for investigation, we cannot confirm this quality complaint.No capa investigation is required at this time per criteria established in wi-03635, "processing essure cases in dev@com." conclusions: the report did not state a patient injury occurred.The possibility of pieces of the delivery system or micro-insert breaking off during the procedure is an anticipated event.According to the dfmea, the main consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Medical assessment this case reported complication of device insertion due to deployment issue of being impossible to release device and withdraw catheter (became broken) resulting in failed bilateral insertion.The events reported are not necessarily indicative of a quality defect.Two (2) additional ae case reports have been received to date in relation to batch number 50750351 and both of these cases refer to a similar type of breakage event.No unusual pattern could be identified at this time.The review of the lot history records confirmed that the product met product release specifications.No complaint sample was provided for a technical investigation.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect".Based on the information available, there is no reason to suspect a quality defect.Upon receipt of ptc results, the event impossible to release the device: broken catheter and impossible withdrawal (device breakage) was amended to listed (anticipated).

Manufacturer Narrative

Follow up 23.Jul.2014: ptc investigation results were updated due to essure sample was sent to the company for further investigation.Final assessment: 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.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.We were able to inspect the micro-insert, the outer catheter, the inner catheter, and all parts within the handle assembly.Micro-insert was stretched and detached.The large tight pitch coil found to be stretched and broken.All ifu steps were completed.No breakage was observed on the delivery catheter.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.We are unable to confirm any quality defect or device malfunction at this time.Conclusions: the report did not state a patient injury occurred.The possibility of a detachment difficulty event during the procedure is an anticipated event.The possibility of pieces of the delivery system or micro-insert breaking off during the procedure is also an anticipated event.According to the dfmea, the main consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Final risk classification: risk category iv.Medical assessment: this case reported complication of device insertion due to deployment issue of being impossible to release device and withdraw catheter (became broken) resulting in failed bilateral insertion.The events reported are not necessarily indicative of a quality defect.One (1) additional ae case report has been received to date in relation to batch number 50750351 which refers to similar type of events.No unusual pattern can be identified at this time.The review of the lot history records confirmed that the product met product release specifications.One device was received for technical investigation.The investigation determined that all ifu steps were completed, micro-insert was stretched and detached, the large tight pitch coil was stretched and broken, and that no breakage was observed on the delivery catheter.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect" and noted that both he detachment difficulty and breakage events are anticipated events.Based on the information available, there is no reason to suspect a quality defect.Follow-up information received by phone call on (b)(4) 2014: the reporter denied to give further information about the case, and referred to medical secret.No further information will be available.Closed case.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 during the procedure it was impossible to release the device: broken catheter and impossible withdrawal and the delivery was not bilateral; a celioscopy was performed to remove the device.Reporter causality was not provided.The event impossible to release the device: broken catheter and impossible withdrawal was interpreted as a deployment issue (impossible to release and withdrawal) and a device breakage (complication of device insertion).The device breakage, was regarded as an incident, due to the required intervention (celioscopy) to remove essure.This event was considered serious and was initially regarded as unlisted according to the reference safety information for essure, however upon the receipt of product technical complaint analysis (ptc) it was considered an anticipated event and thus amended to listed.The remaining events are non-incidents and listed.Single cases of essure breakage have been reported.In this particular case, it was reported that a device breakage and a deployment issue occurred during the placement procedure and bilateral placement was not achieved; considering that the reported events occurred during essure insertion, they were considered as related to essure therapy.According to the first ptc final assessment based on the information available, there was no reason to suspect a quality defect of the product.Ptc investigation results were updated due to essure sample was sent to the company for further investigation and concluded unconfirmed quality defect and based on the information available, there is no reason to suspect a quality defect.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: KNH- DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• 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: 3820086
• MDR Text Key: 4503679
• Report Number: 2951250-2014-00153
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 50750351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Female