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

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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 23-apr-2015 which refers to a female patient of unspecified age who had an attempt to insert essure (fallopian tube occlusion insert) on (b)(6) 2015 for permanent contraception (lot number c40062).Physician reported that a resident deployed the coil distally in right tube.There was an issue with detachment of unit delivery system.The deliver system broke apart and they went in with a grasper and removed remainder of system that broke off.The coil was left in right tube and tubal ligation was performed.Bilateral placement was not achieved.Ptc investigation result was received on 07-may-2015.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: (b)(4).Final assessment: 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 c40062 (production date 01-apr-2014 and expiration date 30-apr-2017) 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 a product quality issue.In addition, 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.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient of unspecified age who had an attempt to insert essure (fallopian tube occlusion insert) and the deliver system broke apart.This event is non-serious and listed in according to technical analysis.Single cases of essure breakage have been reported, mostly during difficult insertions or removals.In this particular case, the physician deployed the essure coil distally in right tube.There was an issue with detachment of unit delivery system.Then, the deliver system broke apart and the piece remainder was removed with a grasper.The coil was left in right tube and tubal ligation was performed.Bilateral placement was not achieved.Considering the reported events occurred associated to insertion procedure, causality with essure use is assessed as related.Although tubal ligation was performed, it was apparently done due to failed insertion as contraceptive method.This case is assessed as other reportable incident since the breakage in this report did not lead to serious injury, however, it might have led under less fortunate circumstances.The technical investigation concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.

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: 4785843
• MDR Text Key: 17630806
• Report Number: 2951250-2015-00334
• 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
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: ESS305
• Device Lot Number: C40062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1