MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fainting (1847); Pain (1994); Vomiting (2144); Heavier Menses (2666)

Event Date 03/01/2013

Event Type  Injury  

Event Description

This spontaneous case report was received by regulatory authority in (b)(6) on 15-mar-2016 from a (b)(6) female consumer and forwarded to bayer on 04-aug-2016.On (b)(6) 2012 essure (fallopian tube occlusion insert) was placed.The consumer was a des daughter.The consumer reported painful placement which took 45 min on the right side.She fainted and had diarrhea and vomiting after the procedure.In (b)(6) 2013 she experienced pain in abdomen, increase or heavy blood loss during menstruation, and mood swings.In an unspecified date she contacted her physician.She had an ultrasound performed; however the results were not provided.On (b)(6) 2014 essure was removed along with one fallopian tube (salpingectomy).She reported work-related problems.After the procedure she was sterilized in the classical manner (left shortened).During removal of the essure coils, it became apparent that there was no fallopian tube and no ovaries on the right.The coil on the right had therefore been inserted loose.She had been having stabbing pain on the right and the left of her abdomen every day since the removal.She was afraid that parts of the coils had been left inside her.The consumer was recovering.Company causality comment this spontaneous case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced pain in abdomen.This event is listed in the reference safety information for essure.Abnormal pain may occur within consumers under essure use.In this present case, consumer stated that, during removal of the essure coils, it became apparent that there was no fallopian tube and no ovaries on the right.The coil on the right had therefore been inserted loose.This could be an alternative explanation for consumer's abdominal pain.However, based on a positive temporal relationship and essure safety profile, the causality between the event pain in abdomen and essure use was assessed as related.This case was regarded as incident since essure removal was required.Other nonserious events were reported.Technical analysis has been requested.No further information is expected from consumer.

Manufacturer Narrative

Follow-up received on 22-sep-2016.Quality- safety evaluation of ptc: ptc global number (b)(4).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.No sample available for this investigation.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.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 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 provided information the defect type corresponds to the following meddra llt: device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.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 23-sep-2016 for the following meddra preferred terms: abdominal pain.The analysis in the global safety database revealed 729 cases.Device breakage.The analysis in the global safety database revealed 1393 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 these meddra pts.Company causality comment: this spontaneous case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced pain in abdomen.This event is listed in the reference safety information for essure.Abnormal pain may occur within consumers under essure use.In this present case, consumer stated that, during removal of the essure coils, it became apparent that there was no fallopian tube and no ovaries on the right.The coil on the right had therefore been inserted loose.This could be an alternative explanation for consumer's abdominal pain.However, based on a positive temporal relationship and essure safety profile, the causality between the event pain in abdomen and essure use was assessed as related.This case was regarded as incident since essure removal was required.Other nonserious events were reported.According to the technical analysis, a product quality defect could not be confirmed but is considered plausible.No further information is expected from consumer.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas CA 95035
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas CA 95035
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd., p o box 915; whippany, NJ 07981-0915
• MDR Report Key: 5913459
• MDR Text Key: 53458762
• Report Number: 2951250-2016-01777
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2016
• 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): Required Intervention; Disability
• Patient Age: 41 YR