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

Model Number ESS305

Device Problems Break (1069); Component Falling (1105); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in united states on (b)(6) 2014 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) implanted on (b)(6) 2014, lot number b82482, inserted for permanent contraception.Physician had inserted two essure devices in patient, bi-laterally.Upon removing the delivery catheter from the deployed second essure, with no deployment problems, the proximal end of the essure outer coil, with approximately five coils and marker, broke off and fell into the uterus.The piece was retrieved from the uterus by the physician at that time and is being saved.Physician stated there were no problems with the insertion or deployment of either of the essure devices in this patient and knows of no cause that would have contributed to this situation's occurrence.Follow up information received on (b)(4) 2014: no new information was provided.Ptc investigation result received on (b)(4) 2014.(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.As of (b)(6) 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.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 micro-insert breaking during the procedure is an anticipated event.Medical assessment: this ptc was initiated due to reported product technical issue (breakage).However, at this point in time no adverse events were reported.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.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 essure (fallopian tube occlusion insert) implanted and the proximal end of the essure outer coil broke off and fell into the uterus.This event, interpreted as device breakage, is listed according to technical analysis and considered a non-serious event.In this case, the breakage occurred during essure insertion procedure.Considering this information, the breakage was assessed as related to essure.This case was regarded as other reportable incident due to the device breakage.The product technical complaint analysis concluded unconfirmed quality defect and considered that there is no reason to suspect a causal relationship to a potential quality deficit.Further information is expected.

Manufacturer Narrative

Follow-up received on 20-apr-2015: final follow-up attempt has been sent with no response to date.Case considered to be closed.Company causality comment: this medically confirmed spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) implanted and the proximal end of the essure outer coil broke off and fell into the uterus.This event, interpreted as device breakage, is listed according to technical analysis and considered a non-serious event.In this case, the breakage occurred during essure insertion procedure.Considering this information, the breakage was assessed as related to essure.This case was regarded as other reportable incident due to the device breakage.The product technical complaint analysis concluded unconfirmed quality defect and considered that there is no reason to suspect a causal relationship to a potential quality deficit.Further information could not be obtained.

Manufacturer Narrative

Data correction for us reporting: the 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: 4413334
• MDR Text Key: 21089778
• Report Number: 2951250-2015-00027
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: ESS305
• Device Lot Number: B82482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 01/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/18/2015; 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR