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

Model Number ESS305

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 01/21/2016

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in united states on (b)(6) 2016 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert), lot number d08062, insertion attempted on (b)(6) 2016.Essure tip broke off during placement into the right fallopian tube.Coils were retrieved intact.No injury to the patient occurred.Bilateral placement not achieved.Converted to tubal.Follow-up information received on 15-feb-2016 and case was upgraded to incident: (b)(4) was identified to be a duplicate of this present case, and all of its information has been transferred to this case.The patient was not pregnant.Essure was inserted for permanent sterilization.The essure tip broke off during placement in right fallopian tube.Hcp removed the coil but the end of the coil did not come out with the device so he had to convert her to a bilateral tubal ligation.All fragments were retrieved.End date of adverse event was reported as (b)(6) 2016.Company causality comment: this medically-confirmed, spontaneous case report refers to a (b)(6) female patient who an attempt of essure (fallopian tube occlusion insert) insertion.During this procedure, the essure tip broke off during placement in right fallopian tube.As the end of the coil did not come out the physician converted the procedure to a tubal ligation and retrieved all essure fragments.The reported event is unlisted according to essure's reference safety information.Single cases of essure breakage have been reported, mainly during difficult insertions.In this case limited information was provided.However, as the event occurred in association with essure procedure; causality with the suspect insert cannot be excluded.This case was upgraded to incident, as although physician stated patient had no injury, a surgical intervention was required for device removal (physician converted the procedure and removed essure fragments).A product technical analysis and follow-up information will be requested.

Manufacturer Narrative

Follow-up received on 07-jun-2016: quality-safety evaluation: this adverse event report is related to a product technical complaint.The bayer reference number for the ptc report is (b)(4).Lot number: d08062; production date: 18-sep-2014; expiration date: 28-sep-2017.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.For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.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 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 micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the available information a product quality defect could not be confirmed but is considered plausible.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.Since no medical events were reported at this point in time, the assessment of a relationship with a quality defect, as well as a batch investigation with respect to similar ae cases, is not applicable.Additional information received on 09-jun-2016 stated that no response was obtained after follow-up attempts.Company causality comment: this medically-confirmed, spontaneous case report refers to a (b)(6) female patient who an attempt of essure (fallopian tube occlusion insert) insertion.During this procedure, the essure tip broke off during placement in right fallopian tube.As the end of the coil did not come out the physician converted the procedure to a tubal ligation and retrieved all essure fragments.The reported event 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.Single cases of essure breakage have been reported, mainly during difficult insertions.In this case limited information was provided.However, as the event occurred in association with essure procedure; causality with the suspect insert cannot be excluded.This case was upgraded to incident, as although physician stated patient had no injury, a surgical intervention was required for device removal (physician converted the procedure and removed essure fragments).Based on the available information a product quality defect could not be confirmed but is considered plausible.No further information is expected.

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: 5446639
• MDR Text Key: 38637905
• Report Number: 2951250-2016-00112
• 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: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: D08062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2016
• 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
• Patient Age: 38 YR