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

Model Number ESS305

Device Problems Break (1069); Sticking (1597); Misfire (2532)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in united states on (b)(6)-2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on (b)(6)-2015.Patient was in the o.R.(operating room) at time of the report, on (b)(6)-2015, and essure coil deployed coil and it misfired.During the procedure, part of sheath got stuck during deployment because plastic sheath did not come off when coil deployed.Most of coils were visible.The physician cut the coil and was not able to remove small piece of coil still in patient, the spring was half in and half out.The physician could not get cut piece of coil out of patient, he stated that it is a little bit of the coil.It was reported that doctor got most of it out but the tip was stuck in the fallopian tube, and the coil was broken.Follow-up information received on 05-oct-2015 with additional information on 07-oct-2015: during essure insertion, only half of the coil entered the patient's fallopian tube and the other half broke off.The caller stated that the half that entered the fallopian tube has been left inside the patient.Product technical complaint (ptc) investigation result - ptc global number: (b)(4).Final assessment: 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 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 microinsert 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.For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.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 were unable to confirm any quality defect or device malfunction at this time.The possibility of micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a reported technical product issue in the context of a complicated insertion.The case ae case refers also to a device misuse (physician cut the coil).However, no medical events have been reported at this point in time.The technical assessment concluded unconfirmed quality defect.At this point in time no medical events have been reported, therefore a batch investigation with respect to similar ae cases is not applicable.In summary, based on the available information there is no reason to suspect a causal relationship to a potential quality deficit as no defect was confirmed and no medical events were reported.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and during the procedure the coil was broken.This event, interpreted as device breakage, is non-serious and anticipated according to the technical analysis.During difficult insertions, single cases of device breakage have been reported.In the present case, during insertion procedure part of sheath got stuck during deployment because plastic sheath did not come off when coil deployed.The physician stated that he cut the coil and was not able to remove small piece of coil still in patient, but also mentioned that the tip was stuck in the fallopian tube, and the coil was broken.Since these events occurred during essure insertion procedure, a causal relationship with essure cannot be excluded.This case was regarded as other reportable incident due to device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.The technical assessment concluded unconfirmed quality defect.Based on the available information there is no reason to suspect a causal relationship to a potential quality deficit as no defect was confirmed and no medical events were reported.Further information has been requested.

Manufacturer Narrative

Follow up information received on 27-oct-2015: patient was (b)(6).On (b)(6) 2015 she had essure inserted, lot number c59250.It was reported that upon deployment of the device by the physician only half of the coil entered the fallopian tube, the remaining half was left out in the uterine cavity.The physician attempted to remove the coil but was unable to do so.The part of the coil that entered into the uterine cavity was cut off and the other part left in place.Bilateral placement was partially achieved.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and initially it was reported that during the procedure the coil was broken.However, upon follow up information, it was clarified that the physician upon deployment of the device only half of the coil entered the fallopian tube, the remaining half was left out in the uterine cavity.The physician attempted to remove the coil but was unable to do so, so the part of the coil that entered into the uterine cavity was cut off and the other part left in place.The previously reported device breakage was now interpreted as a device use error since it was not broken, it was actually cut off.This error is non-serious and listed in the reference safety for essure.Considering the nature of these occurrences, the deployment issue and device use error are assessed as related to essure inserts.Upon follow up information, since it was clarified that the insert was cut rather than broken, the case was no longer regarded as other reportable incident, the case was regarded as non-incident.The technical assessment concluded unconfirmed quality defect.Based on the available information there is no reason to suspect a causal relationship to a potential quality deficit as no defect was confirmed and no medical events were reported.

Manufacturer Narrative

Data correction for us reporting.The code (b)(4) was replaced with (b)(4).

• 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: 5168103
• MDR Text Key: 29840081
• Report Number: 2951250-2015-01215
• 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
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2017
• Device Model Number: ESS305
• Device Lot Number: C59250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• 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 Age: 33 YR