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

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Entrapment of Device (1212); Material Deformation (2976); Positioning Problem (3009)

Patient Problem Physical Entrapment (2327)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in the united states on (b)(6) 2014 which refers to a female pt of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced the coil and sheath got caught in the fallopian tube and the coil fell apart (device insertion failed, complication of device insertion).No info given on pt's history, past drugs, concurrent conditions and concomitant medications.On (b)(6) 2014 the pt had essure (fallopian tube occlusion insert) inserted, lot number a95863.The coil and sheath got caught in the fallopian tube and the coil fell apart (complication of device insertion).Bilateral placement was not achieved (device insertion failed).Pt was fine.No further info was provided.Addendum (b)(6) 2014: despite several follow-up attempts no new info could be obtained.Follow-up ptc final result received on (b)(6) 2014: ptc global number: (b)(4).Final assessment: lot history record (lhr) reviewed.Product met product release specifications.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: this case reported device breakage due to complication of insertion and difficult to use due to bilateral placement not being achieved.These reported events are not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.Three (3) additional ae case reports have been received to date in relation to batch number (b)(4) and these cases refer to events of difficult to use and complication of insertion (all due to tubal spasm) but none of these cases refers to device breakage.No batch signal could be identified at this time.The review of the lot history records confirmed that the product met product release specifications.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.Follow-up on (b)(6) 2014: healthcare professional questionnaire was returned.The (b)(6) year old pt, height 5 feet 5 inches, weight (b)(6), had no gynecological interventions (a cervical conization, curettage, previous ius/iud (intrauterine system or device), myomectomy, adnexal surgery) in the past, and no previous gynecological problems or procedures, and no other relevant medical history or concurrent conditions.Pt was to have essure (ess305, lot number a95863, expiration date on 01/2016) inserted when she was not postpartum.Cervical dilatation was performed, but no sounding, and no general anesthesia were done.Analgesia was performed with oral toradol (ketorolac tromethamine) 10mg, oral valium (diazepam) 10 mg.Insertion was difficult, the sheath of device did not release and coil stretched and deformed.There was no fluid loss during hysteroscopy of more than 1500cc.Procedure took longer than 20 minutes, 49 minutes exactly.Visualization of tubal ostia was easy.It was also reported procedure was aborted due to poor hysteroscopic visualization and pt discomfort.Pt left without essure.No treatment was required for reported events, no diagnostic tests performed, not pathological results, no hospitalization occurred.Reporter stated the condition was caused by essure devices, the sheath did not release and coil was deformed.Ptc investigation result was received on (b)(4) 2014.No new info.Correction on (b)(6) 2014 with info received on (b)(6) 2014: the case incident category, previously downgraded from near-incident to non-incident on (b)(6) 2014, was after a company internal review amended to near-incident.Also, after the review of the ptc result the event: the coil and sheath got caught in the fallopian tube and the coil fell apart was considered as anticipated and thus, listed.

Manufacturer Narrative

Information from duplicate case 2014-064799 added on 06-jun-2014: it was reported that during the insertion procedure the sheath of the device did not release and the coil stretched and deformed.The coil hung out into the pt's vagina.It was also reported that the coil could be visualized outside the vagina.The reported indication for essure are added as contraception.Product technical complaint investigation and final assessment were received.This adverse event report is related to a product technical complaint (ptc) - usability issue.The bayer ref number for the ptc report is: 2014-011516 and the local number is (b)(4).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 and perform final rollback.Under normal circumstances, when the physician completes all deployment steps as outlined in the ifu, the microinsert 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 cause are tubal spasms which can clamp down on the distal end of the catheter and prevent the microinsert 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 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 at this time.Medical assessment: this case reported device issues expulsion due to a deployment/malfunction issue (didn't release), use error (stretched) as well as a physical property issue (deformed).These events also are not necessarily indicative of a quality defect.Four (4) additional ae case reports have been received to date in relation to batch number a95863 but only one (1) of these cases refers to a similar type of deployment and usability event.No batch signal 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.Product technical complaint investigation and final assessment were received on 10-jun-2014: this adverse event report is related to a product technical complaint (ptc) - device breakage.The bayer reference number for the ptc report is: (b)(4) and the local number is (b)(4).Final assessment: when a term like "falling apart" 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.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, outer catheter, the inner catheter, and all parts within the handle assembly 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 at this time.No capa investigation is required 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 insertion because of device breakage due to deployment issues (device sheath not releasing) and use error (stretched) as well as difficult to use due to failed insertion of the one device.These reported technical events are not necessarily indicative of a quality defect.Three (3) additional ae case reports have been received to date in relation to batch number a95863 and these cases refer to events of difficult to use and complication of insertion (all due to tubal spasm) but none of these cases refers to device breakage.No batch signal 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 time of this medical assessment the technical investigation concluded "unconfirmed quality defect" but a handling error could not be ruled out.Additionally, the reported event of breakage is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) years-old female patient who had essure (fallopian tube occlusion insert) inserted and experienced the coil and sheath got caught in the fallopian tube and the coil fell apart.This non-serious event, interpreted as a device breakage and previously considered unlisted according to reference safety information for essure, was, upon receipt of product technical investigation (ptc) updated to listed (anticipated).During difficult insertions, single cases of essure breakage have been reported.In this particular case, it was mentioned that the coil and sheath got caught in the fallopian tube and the coil fell apart.Later the non-serious, listed events coil stretched and deformed, discomfort and sheath of device did not release were also reported, suggesting a difficult insertion.Thus, causal relationship between the events and essure use is assessed as related.The ptc analysis concluded to an unconfirmed quality but a handling error could not be ruled out.Ptc medical assessment considered that based on the information available; there is no reason to suspect a 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: 3872124
• MDR Text Key: 4564477
• Report Number: 2951250-2014-00194
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: ESS305
• Device Lot Number: A95863
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2014
• 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: 30 YR
• Patient Sex: Female
• Patient Weight: 57 KG