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

Model Number ESS305

Device Problems Break (1069); Positioning Failure (1158); Entrapment of Device (1212); Material Frayed (1262); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a nurse and physician in united states on (b)(4) 2014 which refers to a (b)(6) female patient who had an attempt to have essure (fallopian tube occlusion insert) inserted and experienced the wire applicator, plastic sheath and coil of one side got stuck in the tube after fraying, insert did not deploy when she pressed the button, may have perforated the tube during insertion procedure, inserter inner catheter stretched while it was attached to the device, and stretched out this coli and it eventually broke due to the tension / a portion of the insertion cath is still in the patient.No information given on patient's history, past drugs, concurrent conditions and concomitant medication.The patient was not pregnant.On (b)(6) 2014, the patient had an attempt to have essure (fallopian tube occlusion insert ) inserted for contraception, lot number b93871.The nurse called requesting immediate assistance regarding essure placement procedure that was taking place during call the wire applicator, plastic sheath and coil of one side got stuck in the tube after fraying and snapping and could not be removed with tension.The physician had difficulty deploying essure insert, as the insert did not deploy when she pressed the button.She also believed they may have perforated the tube.She tried to pull back on the inserter was unable to detach insert.She removed the hysteroscope and inserter.This stretched the inner catheter out the cervix and then it snapped free.She said that the green sheath was still in the ostia and this wire was stretched to the cervix.A picture was sent and it appeared that inserter inner catheter stretched while it was attached to the device, as physician removed hysteroscope it stretched out this coil and it eventually broke due to the tension.The coil was removed via hysteroscopy, although they were unable to cut essure, having broken two pairs of scissors.It seemed that a portion of the insertion catheter was still in the patient as the green and coils from the inner catheter could be seen.No perforation or bleeding was confirmed.Reporter causality: the relationship was not reported.

Manufacturer Narrative

Follow-up received on 20-may-2014.No new clinical information provided.Addendum 30-may-2014: despite several follow-up attempts no new information could be obtained.Ptc investigation result received on 03-jun-2014.Ptc global number: (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: 1) rollback to initial hard stop 2) depress button 3) 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 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 difficult to use due to deployment issue when pressing button as well as on pulling back and user error due to breakage from stretching catheter.These events are not necessarily indicative of a quality defect.No additional ae case reports have been received to date in relation to batch number b93871.No batch signal can 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" and included handling error as well as product release impossible/incomplete as part of the error classification.Based on the information available,there is no reason to suspect a quality defect.Company causality comment: a spontaneous case of stretched out this coil and it eventually broke due to the tension/a portion of the insertion cath is still in the patient in a (b)(46 female patient during essure (fallopian tube occlusion insert) insertion procedure was reported by a nurse and a physician.Stretched out this coil and it eventually broke due to the tension/a portion of the insertion cath is still in the patient was regarded as a device breakage.This event is unlisted for essure in the reference safety information.The device breakage did not cause any confirmed harm to the patient until now, but it could have under less favourite conditions.Given the compatible temporal relationship the event stretched out this coil and it eventually broke due to the tension/a portion of the insertion cath is still in the patient was regarded related to essure insertion procedure and considered as near-incident.The other reported events: the wire applicator,plastic sheath and coil of one side got stuck in the tube after fraying, insert did not deploy when she pressed the button, may have perforated the tube during insertion procedure,and inserter inner catheter stretched while it was attached to the device were regarded as non-incidents.According to ptc assessment the technical investigation concluded "unconfirmed quality defect" and included handling error as well as product release impossible/incomplete as part of the error classification.

Manufacturer Narrative

Follow-up information received on (b)(4) 2014: new reporters were added.The patient´s weight was (b)(6) and height was (b)(6).Her concurrent condition included morbid obesity.Her medical history included curettage and a dc in 2010.It was reported that she had 2 expulsions with previous iud/iud.It was reported that cervical dilation and analgesia with lma were done.Sounding was not performed during procedure.The visualization of the tubal ostium was easy.The insertion was difficult; advancing the device was easy but the introducer became stuck in the ostia/tube.No perforation of the tube was noted on laparoscopy (the previous reported event may have perforated the tube during insertion procedure was deleted).The event procedure took 120 minutes and the fluid loss was less than 1500cc.Hysterosalpingogram and imaging tests were not performed because the procedure was converted to tubal ligation.The patient was not hospitalized.According to the reporter, essure was partially removed; could not remove coil and green plastic sheather which were cut 2 cm from ostia.Company causality comment: a spontaneous case of stretched out this coil and it eventually broke due to the tension/a portion of the insertion cath is still in the patient in a (b)(6) female patient during essure (fallopian tube occlusion insert) insertion procedure was reported by a nurse and a physician.Stretched out this coil and it eventually broke due to the tension/a portion of the insertion cath is still in the patient was regarded as a device breakage.This event is unlisted for essure in the reference safety information.The device breakage did not cause any confirmed harm to the patient, but it could have under less favourite conditions.Given the compatible temporal relationship the event stretched out this coil and it eventually broke due to the tension/a portion of the insertion cath is still in the patient was regarded related to essure insertion procedure and considered as near-incident.The other reported events: the wire applicator, plastic sheath and coil of one side got stuck in the tube after fraying, insert did not deploy when she pressed the button, essure was partially removed, coil and green plastic sheather were cut 2 cm from ostia and inserter inner catheter stretched while it was attached to the device were regarded as non-incidents.Initially a suspicion of fallopian tube perforation was also reported, however upon receipt of follow-up information it was confirmed that no perforation occurred and this event was deleted.The product technical complaint (ptc) assessment concluded in its technical investigation to"unconfirmed quality defect" and included handling error as well as product release impossible/incomplete as part of the error classification.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: 3952349
• MDR Text Key: 4605696
• Report Number: 2951250-2014-00236
• 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: Other,Health Professional,health professional,oth
• 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: 07/17/2014
• 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: B93871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2014
• 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: 39 YR
• Patient Weight: 117