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

Model Number ESS305

Device Problems Inadequate or Insufficient Training (1643); Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 05/11/2015

Event Type  Injury  

Event Description

This is a spontaneous case report received from a nurse in (b)(6) on (b)(6) 2015 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert), lot number c64465, inserted on (b)(6) 2015.The physician who placed the essure did not receive the training from bayer health care professional (bhcp) training department, but by physician colleagues.Health care professional reported that, on (b)(6) 2015 during essure placement, two implants in, where a part of the inserter remained (as reported) and informed that it was impossible to release the inserts.The event took place in the operatory room.There was no cause related to the patient that could explain the event.Bilateral placement was done, with another device.No further information was provided.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and it was reported that two implants in where a part of the inserter remained (interpreted as device breakage).It was impossible to release the inserts.The event device breakage was considered serious due to medical importance (by the reporter) and unlisted in the reference safety information for essure.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure insertion procedure, 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.Further information and product technical analysis are being sought.

Manufacturer Narrative

Follow-up received on 18-jun-2015: product technical complaint investigation and final assessment were received: this adverse event report is related to a product technical complaint and was initiated due to a product technical issue.In addition, the ae case refers to a usability issue.The bayer reference number for the ptc report is (b)(4).Final assessment: lot number: c64466 (corrected); production date: 05-jun-2014; expiration date: 30-jun-2017.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.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 and detachment difficulty is an anticipated event.Medical assessment: this ptc was initiated due to a product technical issue reported in the context of a complicated device insertion.The ae case refers to a usability issue.However, no adverse events have been reported.The batch documentation of the reported batch was reviewed.No complaint sample was provided for a technical investigation.The technical investigation 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.The list of similar cases contains essure reports received by bayer with similar events coded in (b)(4).In this particular case a search in the database was performed on 19-jun-2015 for the following (b)(4) preferred term: device breakage.The analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this (b)(4) pt.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and it was reported that two implants in where a part of the inserter remained (interpreted as device breakage).It was impossible to release the inserts.The event device breakage was considered serious due to medical importance (by the reporter) and 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.As the device breakage occurred during essure insertion procedure, 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.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.No further information is expected.

Manufacturer Narrative

Follow-up received on 19-aug-2015: no further information was obtained.Case considered closed.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 20-aug-2015 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and it was reported that two implants in where a part of the inserter remained (interpreted as device breakage).It was impossible to release the inserts.The event device breakage was considered serious due to medical importance (by the reporter) and 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.As the device breakage occurred during essure insertion procedure, 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.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.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: 4823454
• MDR Text Key: 17546896
• Report Number: 2951250-2015-00373
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,foreign,health profe
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: ESS305
• Device Lot Number: C64465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2014
• 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 Outcome(s): Other
• Patient Age: 35 YR