Summary of MedSun Reports Describing Adverse Events With Fallopian Tubal Occlusion Devices (TOD)
MedSun: Newsletter #49, June 2010

The Devices that will be included in the analysis below include: Essure by Conceptus, Inc., Filshie Clip System by Femcare-Nikomed, LTD, and the Falope-Ring Band System by Gyrus/ACMI. A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The indications for use of these devices is permanent female sterilization, to prevent pregnancy [1].

Over the past 2 years, MedSun has received 20 adverse event reports associated with the Essure device, manufactured by Conceptus, Inc.; 3 reports associated with the Falope-Ring® Band System, manufactured by Gyrus Medical Inc.; and 2 reports associated with the Filshie Clip System manufactured by Femcare-Nikomed, LTD, and distributed by Cooper Surgical. The 25 reports were submitted by 11 hospitals between May 2008 through April 2010. The majority of reports indicated device deployment issues. The deployment issues included, failure to deploy, malfunction after deployment, and difficulties with proper deployment.

The actual reported Essure™ device problems were:
• Device Problem 1: 12 reports of deployment issues
• Device Problem 2: 4 out of box issues, which included 3 reports with bent tips, and 1 report which mentions difficulty during loading of the device
• Device Problem 3: 2 reports of perforation
• Device Problem 4: 1 report mentions defective device
• Device Problem 5: 1 report mentions that the broke inside the uterus during deployment

In four of the above listed events, patient injuries were reported. Descriptions of the reported injuries are provided below:
• Patient Problem 1: 2 reports mention perforation. One involved perforation of the fallopian tube, which then resulted in the procedure converted to a laparoscopic tubal ligation. The other report mentions a uterus perforation discovered during a later laparoscopic procedure.
• Patient Problem 2: An improperly deployed Essure device resulted in a conversion to a laparoscopic procedure for completion of the sterilization.
• Patient Problem 3: Another report mentions abdominal pain experienced by the patient, resulting in diagnostic laparoscopy preformed. During the diagnostic laparoscopy, it was discovered that the Essure device had migrated to the bowel.

The actual reported Falope-Ring® Band device problems were:
• Device Problem 1: 1 report of misfire
• Device Problem 2: 1 report of deployment issue
• Device Problem 3: 1 report of malfunction

The actual reported Filshie Clip System device problems were:
• Device Problem 1: 1 report which lists 4 unintended pregnancies following the procedure
• Device Problem 2: 1 report of device migration

Given that the three devices are used for female permanent sterilization, all of the reports involved female patients. The age range for the patients, under this review, was all of the patients were over the age of 21.

These MedSun reports contributed to FDA awareness of the device problems. The FDA continues to follow-up with the manufacturers.

The following table lists the MedSun reports that are described in the device problem summary above.
Device Problem Table: Essure
DeviceDevice Identifier Event Description
Conceptus, Inc Essure™ Cat. #ESS305, Lot#20227514 The device was removed from an intact Essure™ box with no visible damage to the box or inner package. The device was visible through the clear plastic package insert where upon removal from the box it was noted the device tip was malformed in a bent elbow position. The device should be straight.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot#685785 The device failed to deploy.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot#20210352 The patient who was desiring permanent sterilization underwent placement of the Essure™ device. During the procedure the Essure™ deployed. Per the operative note, the Essure™coil did not properly deploy.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot#654830 During a hysteroscopy procedure, the first Essure ™device obtained from the kit was apparently defective with a bent tip with the second Essure™ device obtained from the kit apparently unsuccessful; questionably related to the patient's anatomy. Procedure converted to a laparoscopic tubal ligation with another device.
Conceptus, Inc. Essure™ Lot #646522 As the surgeon was attempting to place the Essure™ resistance was met. The surgeon did not "feel" that they had proper placement so they attempted to remove some extra tissue and saw some bleeding. The surgeon then explored the fallopian tube and saw a perforation; therefore did not place the Essure™. They stopped the procedure and did a laparoscopic bilateral tubal ligation with another device.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #20183089 While performing a hysteroscopic tubal ligation, the Essure™ device was found to be defective. It was noticed on the monitor while inside the patient. The device was removed immediately.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #619695 Device failed to discharge properly.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #637215 and Lot #638494 On a first attempt to place the Essure™ on the patient's right side, physician experienced a "failure to deploy". There was a second attempt made to place an Essure™ with a different Lot#. With this second attempt the physician experienced "subsequent difficulty with visualization. Once placement located the second Essure™ didn't expand." The procedure was aborted with a hysteroscopic time of 40 min. Both sets of Essure™ devices with packaging were to return to the company.
Conceptus, Inc. Essure™ Lot #628434 An initial procedure was performed several months ago on the patient. At the time of this procedure, detachment of a 2cm endometrial fibroid was via cautery was attempted. The removal of the fibroid was very difficult. Several attempts were made to remove the fibroid without success and the decision was made to leave it in place. Then months later an Essure™ placement was then attempted. A difficult visualization was reported on the right fallopian tube as the tubal ostium was somewhat occluded by endometrial tissue and on the left fallopian tube the tubal ostium was occluded by area of dissection of the previous fibroid. Three days after this procedure the patient returned to surgery for abdominal pain. At this time a diagnostic laparoscopy was preformed. The Essure™ spring was identified partially imbedded in the patient's bowel. The physician successfully removed the spring and the patient tolerated the procedure well.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #627301 The Essure™ device did not deploy. During the deployment attempt, the surgeon was not able to "thumbwheel" back a second time after depressing the button. The surgeon then successfully withdrew the device. No injury to the patient was noted.
Coneptus, Inc. Essure™ Cat. #ESS305, Lot #626975 The Essure™ device did not deploy. The surgeon was not able to roll the thumb wheel back because it became stuck. The surgeon withdrew the device successfully. No patient injury was noted.
Coneptus, Inc. Essure™ Cat. #ESS305, Lot #627751 Upon opening the package, the device had a bent tip and surgeon was unable to place the device successfully. The surgeon removed the device from tube. No patient injury noted.
Coneptus, Inc. Essure™ The Essure™ device was placed in patient a year ago. Follow-up x-rays showed proper placement two months post operatively. Approximately 13 months later, the surgeon was performing a laparoscopic procedure on the patient. The surgeon found the Essure™ device that had been put in the patient had failed by extruding through her uterus. The surgeon called the company during surgery but there was no response from company. Company responded to our Risk Department several days following the procedure.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #627310 Coil on the Essure™ device did not release as expected.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #627310 Coil on the Essure™ device did not release as expected.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #626625 Attempted to use the Essure™ device, but device would not deploy.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #626625 The surgeon attempted to deploy the device on the right side, but it did not deploy. The surgeon then attempted to deploy the device on the left side. The device came out after it was inserted. There was no harm to the patient.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #624001 Surgeon was trying to load the Essure™ device prior to the procedure and the spring would not unload. Item was replaced. No patient harm.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #626218 The surgeon implanted the Essure™ device and the device broke inside the uterus. All pieces were recovered.
Conecptus, Inc. Essure™ An Essure™ device improperly deployed into the right tubal ostium. This resulted in the conversion to a laparoscopic procedure, where the entire device was successfully removed. With the right tube under direct visualization the Essure™ device was slowly advanced through the tubal ostium. Upon trying to release the device per manufacturer's specifications, the device did not deploy properly. The device was withdrawn. There was some residual wire left within the tube. This was grasped with a grasper and removed entirely. No lasting sequelae for patient. The Essure™ sales rep was present in the OR and took the device. We do not have knowledge of the lot number.



Device Problem Table: Falope-Band
DeviceDevice Identifiers Event Description
Falope Ring® Band System Lot #8191088, Other device #005280 901 ACMI Gyrus Falope-Ring® band misfired -- caused no injury, but a second kit was required to be opened to complete the procedure.
Falope Ring® Band System Lot #1521075H, Catalog #005280-901/Lot #110766GB, Catalog #005280-901 A Disposable Falope-Ring® Band Applicator was passed to the physician. This was the first band that was to be placed for laparoscopic tubal ligation. Placement was incomplete when physician stated that the device did not "deploy" appropriately and the fallopian tube was "cut." A second Disposable Falope Ring® Band Kit (different style kit and Lot. #, but same style applicator) was obtained with the same result when physician attempted to deploy. The physician then stated that he would complete the procedure the "old fashion way!" Both Disposable Falope-Ring® Band Applicator Kits were given to Purchasing to return to ACMI.
Falope Ring® Band System Catalog #000940-501 During the procedure, the surgeon attempted to use the fallopian ring band applicator and noticed it wasn't working. The fallopian tubes had to be burned with another device instead. The fallopian tube bander was repaired and returned to service. This procedure was an outpatient procedure and did not require a hospitalization for the patient. The device was sent to an external repair company who cleaned and reset the tip of the device as it was "a little bit off".




Device Problem Table
DeviceDevice Identifiers Event Description
Filshie Clip System No information provided During a laparoscopic procedure, a loose Filshie clip was found lying inside the operative site. The patient had not had previous surgery at this facility. Unknown date and facility for previous procedure. No patient harm.
Filshie Clip System Lot #20561, Catalog #AVM851, Other Device #FE0105 Four unintended pregnancies were reported from patients and physicians who underwent a tubal ligation procedure during a 13-month period with the Filshie Clip System. The Filshie Clips used in the procedures were from the same lot number.

Additional Information:

1. Code of Federal Regulations Title 21, Part 884.5380. Contraceptive tubal occlusion device (TOD). Retrieved May 21, 2010. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=884.5380&SearchTerm=%20tubal%20occlusion%20devices


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