MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261); Difficult to Insert (1316); Difficult to Remove (1528); Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

Patient Problem Pain (1994)

Event Date 06/28/2016

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in united states on 30-jun-2016 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2016 for contraception.Additional information received on 01-jul-2016.It was reported that in the or the device would not deploy from the delivery catheter and because it did not detach the medical doctor tried to go in and remove it.But when he went to remove, it broke into pieces.According to the reporter, the right insert was not inserted.The essure device malfunctioned and broke inside the patient's body.The left insert was not done.A laparoscopy was done and the doctor removed the entire tube with device in it (he thought he got all of the particles of the device).After that, an x-ray and ct scan were done and 2 particles of about 0.5cm were seen and physician did not known if it was a part of device or clip from appendectomy that was done in the patient in the past.The patient was having pain.According to the reporter, she had her tubes tied and cut and her symptoms are due to secondary tubal surgery from which she is recovering.Follow-up received on 15-jul-2016: quality safety evaluation of ptc: (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.Deployment difficulty is defined as a failure of the micro-insert outer coils to expand from the wound down position.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper deployment: rollback to initial hard stop.Depress button.Perform final rollback.Under normal circumstances, when the physician completes the proper essure placement steps, the release ribbon should disengage from the platinum half band (welded onto outer coils of micro-insert).Once disengagement occurs, the outer coils should expand.If it does not, this is referred to deployment difficulty.Several factors can contribute to a deployment 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 expanding and 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.No sample available for this investigation.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.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 deployment 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 minimize the residual risk.Based on the provided information the defect type corresponds to the following meddra llt: device deployment issue and device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the medical event is a known, possible, undesirable event and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Company causality comment: this medically-confirmed, spontaneous case report refers to a female patient who had an attempt of essure (fallopian tube occlusion insert) insertion.During the procedure the device would not deploy from the delivery catheter and when the physician tried to remove it, it broke into pieces (inside of patient's body).A laparoscopic salpingectomy was done, but x-ray and ct scan were later performed and showed 2 particles of about 0.5cm (physician is unsure if they were part of the device or surgical clips).The reported device breakage is anticipated according to the technical assessment.In this particular case, the event occurred in the context of a difficult essure insertion due to a device deployment issue.Therefore, causality with the suspect insert cannot be excluded.This case was regarded as incident, since a surgical intervention was required.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the medical event is a known, possible, undesirable event and not indicative of a quality deficit per se.Follow-up information is expected.

Manufacturer Narrative

Follow-up from 11-oct-2016: follow-up attempts have been completed, with no response to date.Company causality comment: this medically-confirmed, spontaneous case report refers to a female patient who had an attempt of essure (fallopian tube occlusion insert) insertion.During the procedure the device would not deploy from the delivery catheter and when the physician tried to remove it, it broke into pieces (inside of patient's body).A laparoscopic salpingectomy was done, but x-ray and ct scan were later performed and showed 2 particles of about 0.5cm (physician is unsure if they were part of the device or surgical clips).The reported device breakage is anticipated according to the technical assessment.In this particular case, the event occurred in the context of a difficult essure insertion due to a device deployment issue.Therefore, causality with the suspect insert cannot be excluded.This case was regarded as incident, since a surgical intervention was required.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the medical event is a known, possible, undesirable event and not indicative of a quality deficit per se.Despite follow up attempts, no further information was obtained.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas CA 95035
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd.; milpitas CA 95035
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5826391
• MDR Text Key: 50566358
• Report Number: 2951250-2016-01208
• 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
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention