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

Model Number ESS305

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in (b)(6) on (b)(6) 2016 which refers to a female patient of unspecified age who had an attempt of essure (fallopian tube occlusion insert) insertion on (b)(6) 2016, with lot number d35378.During the device placement in the left tube, when trying to deploy the device, correct insertion was not achieved.The device got fixed to the proximal portion of the fallopian tube.When extraction was attempted, the device broke and some fragments remained inside the tube.These fragments were later removed.Bilateral placement was not successful.Patient status was reported as no injury.Follow-up information received on 03-may-2016: (b)(6).Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had an attempt of essure (fallopian tube occlusion insert) insertion.During the procedure, the device got fixed to the proximal portion of the fallopian tube.When extraction was attempted, the device broke and some fragments remained inside the tube.These pieces were later removed.The patient had no injury.These events are listed according to essure's reference safety information.Single cases of essure breakage have been reported, mainly during difficult removals.In this particular case, the physician had a deployment difficulty, the device became fixed in the proximal fallopian tube and when he tried to remove it, it broke.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 patient had no injury, this might have occurred under less fortunate circumstances.A product technical analysis and follow-up information will be requested.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of device breakage ("fragments remained inside the tube/device breakage"), complication of device removal ("complication of device removal"), complication of device insertion ("bilateral placement was not successful"), device deployment issue ("the device got fixed to the proximal portion of the fallopian tube") and wrong technique in product usage process ("handling error") in a female patient who had essure (batch no.D35378) inserted.On (b)(6) 2016, the patient had essure inserted.On the same day, the patient experienced device breakage, complication of device removal, complication of device insertion and device deployment issue.On an unknown date, the patient experienced wrong technique in product usage process.At the time of the report, the device breakage had resolved and the complication of device removal, complication of device insertion and wrong technique in product usage process outcome was unknown.The reporter provided no causality assessment for complication of device insertion, complication of device removal, device breakage, device deployment issue and wrong technique in product usage process with essure.The reporter commented: during the device placement in the left tube, when trying to deploy the device, correct insertion was not achieved.The device got fixed to the proximal portion of the fallopian tube.When extraction was attempted, the device broke and some fragments remained inside the tube.These fragments were later removed.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 31-may-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1628 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.Quality-safety evaluation of ptc: 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.Based on the technical assessment, a complaint sample and lot number were provided therefore, the quality unit reviewed the manufacturing batch record and inspected the returned sample.The quality unit is unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.However, a handling error was concluded and there is likely a relationship between the complaint and the handling error.Most recent follow-up information incorporated above includes: on 30-may-2017: quality-safety evaluation of ptc.(b)(4).Company causality comment: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• 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. lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5647764
• MDR Text Key: 45494760
• Report Number: 2951250-2016-00563
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: ESS305
• Device Lot Number: D35378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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