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

Model Number ESS305

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/17/2015

Event Type  Injury  

Event Description

This is a spontaneous case report received from a physician in united states on 17-jul-2015 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert), lot number c18705, inserted on (b)(6) 2015 for sterilization.On (b)(6) 2015 a follow up hsg (hysterosalpingogram) confirmation on essure was performed and showed that the tubes were blocked, but the tip of one of the devices (left) was broken in 2 pieces.Essure was not removed.Follow-up information was received on 22-jul-2015: physician stated that both inserts were in proper location with bilateral occlusion.Stretching of proximal coils was reviewed and the physician was advised to contact radiologist and determine if that was what the radiologist was seeing.No further information was provided.Follow-up received from physician on 22-jul-2015: physician stated per radiologist the insert is >50% in the uterine cavity (proximal placement) and distal markers are separated not proximal.According to the reporter patient had no complaints.Follow-up received on 01-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 reported product technical issue.The bayer reference number for the ptc report is (b)(4) and the local number is (b)(4).Final assessment: lot number: c18705; production date: 27-jan-2014; expiration date: 31-jan-2017.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.In this case it is unclear if the insert is actually broken, or if the insert has been stretched or bent and appears to be broken since in many cases only the radiopaque markers are visible on hsg images, which leads some radiologists to assume the device is broken.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 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 the 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.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 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 a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and at 3-month control hysterosalpingogram (hsg) one of the devices (left) was broken in 2 pieces.According to the radiologist, essure distal markers were separated not proximal and the insert was >50% in the uterine cavity.The reported events were regarded as suspicion of device breakage and as device dislocation (essure protruding into uterine cavity).Device dislocation is listed in essure's reference safety information and was considered serious due to medical importance; while the other event is non-serious and listed according to technical analysis.In this particular case, control hsg revealed bilateral tubal occlusion; however the device was dislocated and reporter suspected it could be broken.Considering events' nature a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to suspicion of device breakage, as although patient had no injury this might have occurred under less fortunate circumstances.The product technical analysis concluded unconfirmed quality defect.There is no reason to suspect a causal relationship to a potential quality deficit as based on this report.Follow-up information will be requested.

Manufacturer Narrative

Internal communication received on 27-oct-2015: follow-up attempts were done with no response to date.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and at 3-month control hysterosalpingogram (hsg) one of the devices (left) was broken in 2 pieces.According to the radiologist, essure distal markers were separated not proximal and the insert was >50% in the uterine cavity.The reported events were regarded as suspicion of device breakage and as device dislocation (essure protruding into uterine cavity).Device dislocation is listed in essure's reference safety information and was considered serious due to medical importance; while the other event is non-serious and listed according to technical analysis.In this particular case, control hsg revealed bilateral tubal occlusion; however the device was dislocated and reporter suspected it could be broken.Considering events' nature a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to suspicion of device breakage, as although patient had no injury this might have occurred under less fortunate circumstances.The product technical analysis concluded unconfirmed quality defect.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.

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: 5001124
• MDR Text Key: 22900588
• Report Number: 2951250-2015-00602
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: ESS305
• Device Lot Number: C18705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/23/2015; 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• 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
• Patient Age: 39 YR