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

Model Number ESS305

Device Problems Difficult to Remove (1528); Sticking (1597); Stretched (1601); Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a gynecologist/obstetrician in united states on (b)(6) 2015 which refers to (b)(6) female patient.She had an attempt of essure (fallopian tube occlusion insert) insertion (with lot number c51077) for permanent contraception on (b)(6) 2015.It was reported that the device got stuck in the tube, as the physician was retracting the catheter, the inner coil got stretched out, it would not detach, and physician took hysteroscopic scissors and cut it.The patient was okay; essure was continued.Follow-up from (b)(6) 2015: ptc (product technical complaint) was received.Ptc global number: (b)(4).Final assessment batch number c51077; production date 25-apr-2014; expiration date 30-apr-2017 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.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 were unable to confirm any quality defect or device malfunction at this time.The possibility of a detachment difficulty event during the procedure is an anticipated event.Medical assessment this ptc was initiated due to a reported product issue and a usability issue.However, no adverse events were reported at this point in time.The batch documentation of the reported batch was reviewed.No complaint sample was provided for further technical investigation.The technical assessment concluded unconfirmed quality defect.Since no adverse events have been reported, a batch investigation with respect to similar ae cases is not applicable.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had an attempt of essure (fallopian tube occlusion insert) insertion and during the procedure the device became stuck in the tube.The inner coil got stretched when physician retracted the catheter and as it would not detach; the physician had to cut it with hysteroscopic scissors.The reported events were considered non-serious and are listed in essure's reference safety information.During difficult insertions essure placement may be unsuccessful; in this particular case considering that the events occurred in association with essure placement a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident as although physician stated patient was okay, the events might have led to serious deterioration in health under less fortunate circumstances.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up information is being sought.

Manufacturer Narrative

Device breakage questionnaire received on 31-aug-2015 the patient's weight was (b)(6) and height was (b)(6).Her concurrent condition included overweight.Essure was inserted on (b)(6) 2015 with lot number c51077 ((b)(4)).Device breakage occurred during placement.Coil did not deploy correctly and white part of delivery catheter broke, so distal piece had to be removed with hysteroscopy graspers.Physician described that device was easily placed into tubal ostium.Pulled back a little so black band was visible but coil back and delivery catheter did move back after pushing release button.Coil did not release.Delivery catheter became stuck and broken when being pulled.Any deviation from the insertion procedure as described in the ifu was denied.Broken pieces were retrieved from uterus and fallopian tube.Essure was not removed and injury to the patient was denied (no pain).The other tube was not done.The outcome of the breakage was recovered, resolved.Doctor reported that several incidents of issue occurred because of devices deployed incorrectly.He thinks that the problem is in the button in handle not releasing completely.Updated product technical complaint (ptc) investigation result received on 02-sep-2015 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 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.Since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.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 were unable to confirm any quality defect or device malfunction at this time.The possibility of the catheter breaking and detachment difficulty 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 and a usability issue.The batch documentation of the reported batch was reviewed.No complaint sample was provided for further technical investigation.The technical assessment concluded unconfirmed quality defect.The reported adverse event is a known possible undesirable event and not indicative of a quality defect.No similar ae case reports have been received to date in relation to the reported batch.No batch signal could be identified.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had an attempt of essure (fallopian tube occlusion insert) insertion and during the procedure the device became stuck in the tube.The inner coil got stretched when physician retracted the catheter and as it would not detach; the physician had to cut it with hysteroscopic scissors.According to follow up information, the delivery catheter broke (device breakage).All previously reported events are non-serious and listed.Device breakage is non-serious and listed according to the product technical analysis (ptc), while the other events are listed in the reference safety information for essure.During difficult insertions essure placement may be unsuccessful and device breakage may occur.In this particular case considering the events occurred in association with essure placement a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident as although physician stated patient had no injury, the events might have led to serious deterioration in health under less fortunate circumstances.The technical assessment concluded unconfirmed quality defect.No similar case reports have been received to date in relation to the reported batch.No batch signal could be identified.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.

Manufacturer Narrative

Follow-up information received on 21-jul-2015 it was reported that the delivery catheter broke and the coil did not deploy.It was stucked in her left fallopian tube; it was too far down.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had an attempt of essure (fallopian tube occlusion insert) insertion and during the procedure the device became stuck in the tube.The inner coil got stretched when physician retracted the catheter and as it would not detach; the physician had to cut it with hysteroscopic scissors.According to follow up information, the delivery catheter broke (device breakage), it did not deploy and then, was stuck in fallopian tube and it was too far down (device dislocation).All previously reported events are non-serious and listed.Device breakage is non-serious and unlisted in the reference safety information for essure, while device dislocation is serious due medical importance and listed.During difficult insertions essure placement may be unsuccessful and device breakage may occur.Also, there is a risk that the device could move into fallopian tube.In this particular case considering the events occurred in association with essure placement a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident as although physician stated patient was okay, the events might have led to serious deterioration in health under less fortunate circumstances.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.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: 4894822
• MDR Text Key: 6537870
• Report Number: 2951250-2015-00494
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: ESS305
• Device Lot Number: C51077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2014
• 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: 25 YR
• Patient Weight: 55