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

Model Number ESS305

Device Problems Break (1069); Separation Failure (2547)

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

Event Type  Injury  

Event Description

This is a spontaneous case report received from a gynecologist/obstetrician in (b)(6) on 09-jul-2015 which refers to an adult female patient who had essure (fallopian tube occlusion insert) inserted; the lot number used was c68120.Physician reported that the device was not released and stayed attached to delivery catheter and partially broke at removal (one insertion failure on left side).Bilateral insertion was performed (the left side and right side insertions were performed with one kit).Ptc investigation result received on 31-jul-2015.(b)(4).Lot number c68120 (expiration date 30-jun-2017; production date 19-jun-2014).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 product was returned to us for this complaint, we were able to conduct an investigation of the returned product.We typically inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly.As received, all ifu steps were completed.The device was returned without micro-insert.The catheter large tight pitch coil found to be stretched.We were unable to confirm any quality defect or device malfunction at this time.We also 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.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.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.The returned complaint sample was investigated.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 as based on this report.Company causality comment: this medically confirmed, spontaneous case report refers to an adult female patient who had essure (fallopian tube occlusion insert) inserted and during the procedure one device was not released and stayed attached to delivery catheter and partially broke at removal.The reported events, regarded as a device deployment issue followed by device breakage, were considered non-serious.Device breakage 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.The other event is listed.Single cases of essure breakage have been reported, mainly during difficult insertions.In this particular case, limited information was provided.Nevertheless, considering the events occurred in association with essure procedure, causality with the suspect insert cannot be excluded.This case was regarded as other reportable incident, as although the reported device breakage 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.Follow-up information is being sought.

Manufacturer Narrative

Follow-up information received on 02-nov-2015.No further information obtained despite follow-up attempts.(b)(4).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 03-nov-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 (b)(4) pt.Company causality comment: this medically confirmed, spontaneous case report refers to an adult female patient who had essure (fallopian tube occlusion insert) inserted and during the procedure one device was not released and stayed attached to delivery catheter and partially broke at removal.The reported events, regarded as a device deployment issue followed by device breakage, were considered non-serious.Device breakage 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.The other event is listed.Single cases of essure breakage have been reported, mainly during difficult insertions.In this particular case, limited information was provided.Nevertheless, considering the events occurred in association with essure procedure, causality with the suspect insert cannot be excluded.This case was regarded as other reportable incident, as although the reported device breakage did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit as based on this report.Despite follow-up attempts, no further information was obtained.

• 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: 4964026
• MDR Text Key: 24700251
• Report Number: 2951250-2015-00580
• 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: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: ESS305
• Device Lot Number: C68120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2014
• 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