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

Model Number ESS305

Device Problems Material Fragmentation (1261); Difficult to Remove (1528); Sticking (1597)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in united states on (b)(4) 2016 which refers to a (b)(6) female patient who had an attempt of essure (fallopian tube occlusion insert) insertion on (b)(6) 2016.Physician reported that he placed essure in patient right side, on release the outer coil got stuck on insertor.It finally got release but the coil stretched out, health care professional then decided to go in and remove.The attempt to remove was unsuccessful.Insert outer coil was stretched out and broke off some pieces of the outer coil.The patient had been on the table for one hour and the other side had not been placed.Physician was recommended to stop procedure and evaluate options with patient.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted.During the procedure, on release the outer coil got stuck on insertor.Physician tried to remove it and insert outer coil was stretched out and broke off in some pieces of the outer coil.Only essure breakage is unlisted according to essure's reference safety information.Single cases of essure breakage have been reported, mainly during difficult insertions.In this particular case, essure insertion was complicated by a device deployment issue.Considering the events occurred in association with a difficult essure insertion, causality with the suspect insert cannot be excluded.This case was regarded as other reportable incident, as although the event did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.A product technical analysis and follow-up information will be requested.

Manufacturer Narrative

Follow-up information received on 02-mar-2016: the questionnaire for device breakage with essure was received.The weight of the patient was (b)(6) and height was 66 inches (bmi: 29.854).Essure ess305 lot number was d08058.The physician reported that the breakage occurred in the inner and outer coils during placement.The device did not release and attempts to get it to release caused it to pull part way out of the tube.The instructions in the ifu (instructions for use) were followed with no deviations.A laparoscopic bilateral salpingectomy to remove essure was planned, but it was not yet performed.The physician reported that there was not any patient injury but the breakage could have led to serious injury under less fortunate circumstances.The outcome of the events was reported as recovering (inconsistent information since the device was not yet removed).Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted.During the procedure, on release the outer coil got stuck on insertor.Physician tried to remove it and insert outer coil was stretched out and broke off in some pieces of the outer coil.The inner and outer coils broke.Only essure breakage is unlisted according to essure's reference safety information.Single cases of essure breakage have been reported, mainly during difficult insertions.In this particular case, essure insertion was complicated by a device deployment issue.Considering the events occurred in association with a difficult essure insertion, causality with the suspect insert cannot be excluded.This case was regarded as other reportable incident, as although the event did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.A product technical analysis and follow-up information will be requested.

Manufacturer Narrative

Follow-up received on 05-apr-2016: despite of follow-up attempts, no response was received to date.Quality safety evaluation received on 16-jun-2016: (b)(4).The essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The inserts 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 all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter.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 micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.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 inserts grip on the delivery wire, and potential manufacturing deficiencies.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.Although we were unable to confirm this complaint, it is possible the essure device could have been defective prior to removal from the package.The possibility of a detachment difficulty event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimalize the residual risk.Based on the available information a product quality defect could not be confirmed but is considered plausible.Based on the provided information the defect type corresponds to the following meddra llt: device deployment issue and device breakage.Since no medical events were reported at this point in time, the assessment of a relationship with a quality defect, as well as, a batch investigation with respect to similar adverse event cases are not applicable.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted.During the procedure, on release the outer coil got stuck on insertor.Physician tried to remove it and insert outer coil was stretched out and broke off in some pieces of the outer coil.The the inner and outer coils broke.Essure breakage is listed according to technical investigation results.Single cases of essure breakage have been reported, mainly during difficult insertions.In this particular case, essure insertion was complicated by a device deployment issue.Considering the events occurred in association with a difficult essure insertion, causality with the suspect insert cannot be excluded.This case was regarded as other reportable incident, as although the event did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Based on the available information a product quality defect could not be confirmed but is considered plausible.No further information could be obtained.

• 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: 5473123
• MDR Text Key: 39864184
• Report Number: 2951250-2016-00143
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2014
• Device Model Number: ESS305
• Device Lot Number: D08058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 03/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/31/2016; 07/08/2016; 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2017
• 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 Age: 44 YR
• Patient Weight: 84