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

Model Number ESS305

Device Problem Difficult to Insert (1316)

Patient Problem Perforation (2001)

Event Date 07/01/2015

Event Type  Injury  

Event Description

This is a spontaneous case report received from a physician in (b)(6) on 30-jul-2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2015.During insertion, the ostium had not been easily visible as it was covered with a veil, possible a synechia.At the insertion procedure, there had been no visible trailing coil.The physician reported a suspicion of perforation.In (b)(6) 2015, plain abdomen x-ray at 3 months after insertion was performed and noted that the distance between inserts was too important: upper than 4 cm.A hsg (hysterosalpingogram) was requested by the physician for confirmation.The hsg showed insert like a loop.Insert placement could not confirm tubal occlusion by fibrosis; nevertheless, there was no tubal patency on hsg.The patient was informed about risk of failure in view of local difficulty.A laparoscopy was to be planned in (b)(6).Follow up received on 31-jul-2015: the essure lot number is c68119.Follow up 06-aug-2015: nca reference number from (b)(4) was received: (b)(4).Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and physician reported a suspicion of perforation - distance between inserts was upper than 4 cm on plain abdomen x-ray at 3 months after insertion.This event, interpreted as suspicion of uterine perforation, is serious due to medical significance and listed in the reference safety information for essure.Uterine perforation may occur with any trans-cervical intrauterine procedure; including essure insertion.In this particular case, during insertion the ostium had not been easily visible as it was covered with a veil (possible a synechia).Plain abdomen x-ray at 3 months after insertion showed that the distance between inserts was too important, and physician suspected of perforation.Considering the positive temporal relationship and nature of the reported event, causality with essure cannot be excluded.Additional non-serious event was reported.This case was regarded as incident since surgical intervention will be required (laparoscopy was planned).A product technical analysis and further information have been requested.

Manufacturer Narrative

Follow-up received on 28-aug-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 technical product issue and a usability issue.The bayer reference number for the ptc report is (b)(4).Final assessment: lot number: c68119; production date: 18-jun-2014; expiration date: 30-jun-2017.According to the complaint description, the hsg showed the insert formed as a loop.This is interpreted to mean the insert was probably prolapsed during the insertion procedure.This could be due to user handling issue, or due to an obstruction within the fallopian tube.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 to look for any manufacturing deficiencies.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 are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a technical product issue and a usability issue.The batch documentation of the reported batch was reviewed.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect.The reported adverse event is a known possible undesirable event and not indicative of a quality deficit per se.No similar ae case reports have been received to date in relation to the reported batch.No batch signal could be identified.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up information received on 07-sep-2015 no further information was provided despite follow up attempt.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 09-sep-2015 for the following meddra preferred term: uterine perforation.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 spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and physician reported a suspicion of perforation - distance between inserts was upper than 4 cm on plain abdomen x-ray at 3 months after insertion.This event, interpreted as suspicion of uterine perforation, is serious due to medical significance and listed in the reference safety information for essure.Uterine perforation may occur with any trans-cervical intrauterine procedure; including essure insertion.In this particular case, during insertion the ostium had not been easily visible as it was covered with a veil (possible a synechia).Plain abdomen x-ray at 3 months after insertion showed that the distance between inserts was too important, and physician suspected of perforation.Considering the positive temporal relationship and nature of the reported event, causality with essure cannot be excluded.Additional non-serious event was reported.This case was regarded as incident since surgical intervention will be required (laparoscopy was planned).Based on available information, including review of reported batch number, there is no reason to suspect a quality deficit of the product.No further information was obtained despite follow-up attempts.

• Brand Name: ESSURE
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• 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: 5021852
• MDR Text Key: 23736797
• Report Number: 2951250-2015-00627
• Device Sequence Number: 1
• Product Code: KNH
• 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: Physician
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: ESS305
• Device Lot Number: C68119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2014
• 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; Required Intervention