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

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104); Material Fragmentation (1261)

Patient Problems Cyst(s) (1800); Hemorrhage/Bleeding (1888); Cramp(s) (2193)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a consumer in united states on 13-jun-2016 which refers to a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted in 2009.In 2015, the consumer underwent a rotator cuff surgery.Within the last year (implying 2015), she had severe cramping and excessive bleeding.An ultrasound was done and cyst was found.It was also reported that one of the coils was broken in pieces, coils in right fallopian tube looked like they broke apart.Her fiancee feels sharp object when they have intercourse.Reporter refused interview and follow-up.Quality safety evaluation received on 27-jun-2016: (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.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.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.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 adverse event cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Company causality comment: this spontaneous non-medically confirmed case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and one of the coils is broken in pieces / coils in right fallopian looks like they broke apart.She also reported excessive bleeding (interpreted as genital bleeding).Genital bleeding is a listed event in the reference safety information for essure.Device breakage was previously regarded as unlisted; however upon receipt of the product technical analysis (ptc), which stated that micro-insert breaking off during the procedure is an anticipated event; it was amended to listed.In the present case, limited information was provided.The exact date and mechanism of the device breakage were unknown.Given the nature of the event one of the coils is broken in pieces / coils in right fallopian looks like they broke apart, a causal relationship with essure cannot be excluded.After essure insertion, genital bleeding may occur.In this case, consumer started having genital bleeding approximately 6 years after essure insertion.No alternative explanation was provided.Given the nature of the event excessive bleeding, a causal relationship with essure cannot be excluded.Additional non-serious events were reported.This case was regarded as other reportable incident, as although the device breakage did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Since no batch number was reported, a batch investigation with respect to similar adverse event cases is not applicable.Further information cannot be obtained since consumer refused follow-up.

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: 5776199
• MDR Text Key: 49776751
• Report Number: 2951250-2016-01012
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2017

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 Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2017
• 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): Other