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

Model Number ESS305

Device Problems Material Fragmentation (1261); Difficult To Position (1467); Stretched (1601); Physical Resistance (2578); Device Or Device Fragments Location Unknown (2590)

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

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a medical doctor in united states on (b)(6) 2014 which refers to a (b)(6) female patient who had an attempt to have essure (fallopian tube occlusion insert) inserted on (b)(6) 2014 (lot number b93881).Doctor experienced tubal resistance in first tube.First device was stretched upon cannulation.A second device was used.Device was successfully cannulated but was difficult to roll back upon second wheel back.Device did not easily release from catheter and significantly stretched the inner coil.While attempting removal of the essure device with hysteroscopic graspers, the coil was broken a couple of times.One piece of the outer coil was unaccounted for at the procedure end.Result and assessment of the product technical complaint investigation received on 08-dec-2014: batch number b93881 (production date 09-nov-2013; expiration date 30-nov-2016).Final assessment: 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.As 05-dec-2014, 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, outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.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 or device malfunction at this time.The possibility of pieces of the delivery system or micro-insert breaking off during the procedure and rollback difficulty event are anticipated events.Medical assessment: this ptc was initiated due to a product quality issue.In addition, the ae case refers to a usability issue.The batch documentation of the reported batch was reviewed.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect.One further ae case report has been received to date in relation to the reported batch, which refers also to a similar type of adverse events.No unusual pattern could be identified.The reported adverse event is a known, possible, undesirable event and not indicative of a quality deficit per se.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Ptc global number is (b)(4).Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had an attempt to have essure (fallopian tube occlusion insert) inserted and while attempting removal of the essure with hysteroscopic graspers, coil was broken a couple of times (one piece of the outer coil of device unaccounted for at end of procedure).This event, interpreted as device breakage, is non-serious and was previously regarded as unlisted according to the reference safety information for essure; however upon receipt of the product technical analysis (ptc), which stated that micro-insert breaking off during the procedure is an anticipated event; it was amended to listed.During difficult insertion/removals, single cases have been reported of essure breakage.In this case, the device breakage occurred during essure placement, but while attempting removal if the essure device with hysteroscopic graspers.A causal relationship between this event and suspect insert cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Other non-serious events were reported.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.Further information is being sought.

Manufacturer Narrative

Follow up 12-jan-2015: essure health care provider general questionnaire received from the physician.Previous gynecological problems or procedures include fibroid.On (b)(6)-2014 the physician done cervical dilatation, sounding and general anesthesia during essure insertion and the device did not enter easily, did not roll back and coil broke.The visualization of the tubal ostium was easy, the fluid loss during the hysteroscopy was 1600cc and the procedure took 30 minutes.No imaging tests were performed to confirm essure placement since placement was not achieved.During the essure insertion procedure by hysteroscopy the physician removed pieces, although one small piece of outer coil was missing at the end of procedure.Essure removal was necessary as not properly located.Bilateral tubal ligation laparoscopic was done.No diagnostic tests and pathology results were performed.No hospitalization occurred.Physician confirmed the events and details.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had an attempt to have essure (fallopian tube occlusion insert) inserted and while attempting removal of the essure with hysteroscopic graspers, coil was broken a couple of times (one piece of the outer coil of device unaccounted for at end of procedure).This event, interpreted as device breakage, is non-serious and was previously regarded as unlisted according to the reference safety information for essure; however upon receipt of the product technical analysis (ptc), which stated that micro-insert breaking off during the procedure is an anticipated event; it was amended to listed.During difficult insertion/removals, single cases have been reported of essure breakage.In this case, the device breakage occurred during essure placement, but while attempting removal if the essure device with hysteroscopic graspers.A causal relationship between this event and suspect insert cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Other non-serious events were reported.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.Further information is being sought.

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: 4332774
• MDR Text Key: 5218378
• Report Number: 2951250-2014-00534
• 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,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: ESS305
• Device Lot Number: B93881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/11/2015; 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR