MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Leak/Splash (1354); Device Or Device Fragments Location Unknown (2590); Migration (4003)

Patient Problems Scar Tissue (2060); Foreign Body In Patient (2687)

Event Date 07/29/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device: location of device: free in pelvic cavity") in a (b)(6)-year-old female patient who had essure (batch no.(b)(4)) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "unilateral occlusion (left tube occluded)/failure to occlude (close) fallopian tube(s)" on (b)(6) 2014.The patient's past medical history included gravida i, parity 1 on (b)(6) 2013 and menarche.Concurrent conditions included breast feeding.Concomitant products included oral contraceptive nos since 2008 to (b)(6) 2012 for birth control.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced complication of device insertion ("unable to place right side essure").On (b)(6) 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced scar ("scar tissue build up").On an unknown date, the patient experienced device expulsion ("expulsion of essure device").The patient was treated with surgery (on (b)(6) 2014, bilateral fallopian tube excision (tubal ligation) was done).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, scar, complication of device insertion and device expulsion outcome was unknown.The reporter considered complication of device insertion, device dislocation, device expulsion and scar to be related to essure.The reporter commented: on (b)(6) 2013, right essure placement was done.Three trailing coils were on the right fallopian tube following essure placement diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6) kg/sqm.Pregnancy test urine - on (b)(6) 2013: negative on (b)(6) 2013, findings: bimanual exam, normal size and shaped uterus.No adnexal fullness appreciated.Hysteroscope bilateral tubal ostia noted.Thin endometrium was noted.No evidence of uterine perforation from prior procedure noted.On (b)(6) 2014, hysterosalpingogram revealed unilateral occlusion (left tube occluded), migration of essure device.Other finding: normal appearing endometrium, both ostia abducting difficulty.On (b)(6) 2014, hysterosalpingogram revealed the left fallopian tube did not fill.There was successful closure of the left fallopian tube with the essure closure device.There are small linear defects located along the right and left sides of the endometrial cana.They were compatible with small areas of endometrial scarring or adhesions.Impression: 1.Patent right fallopian tube i the essure closure device was external to the tube and is free within the pelvis 2.Occluded left fallopian tube by the essure closure device.Most recent follow-up information incorporated above includes: on (b)(6) 2018: event personal injuries was deleted.Events added-migration of essure device: location of device: free in pelvic cavity/expulsion of essure device, unilateral occlusion (left tube occluded)/failure to occlude (close) fallopian tube(s), scar tissue build up and unable to place right side essure.Historical conditions and lab data added.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device: location of device: free in pelvic cavity") in a 33-year-old female patient who had essure (batch no.B04850-invalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "unilateral occlusion (left tube occluded)/failure to occlude (close) fallopian tube(s)" on (b)(6) 2014.The patient's past medical history included gravida i, parity 1 on (b)(6) 2013 and menarche.Concurrent conditions included breast feeding.Concomitant products included oral contraceptive nos since 2008 to (b)(6) 2012 for birth control.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced complication of device insertion ("unable to place right side essure").On (b)(6) 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced scar ("scar tissue build up").On an unknown date, the patient experienced device expulsion ("expulsion of essure device").The patient was treated with surgery (on (b)(6) 2014, bilateral fallopian tube excision (tubal ligation) was done).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, scar, complication of device insertion and device expulsion outcome was unknown.The reporter considered complication of device insertion, device dislocation, device expulsion and scar to be related to essure.The reporter commented: on (b)(6) 2013, right essure placement was done.3 trailing coils were on the right fallopian tube following essure placement.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.4 kg/sqm.Pregnancy test urine - on (b)(6) 2013: negative.On (b)(6) 2013, findings: bimanual exam, normal size and shaped uterus.No adnexal fullness appreciated.Hysteroscope bilateral tubal ostia noted.Thin endometrium was noted.No evidence of uterine perforation from prior procedure noted.On (b)(6) 2014, hysterosalpingogram revealed unilateral occlusion (left tube occluded), migration of essure device.Other finding: normal appearing endometrium, both ostia abducting difficulty.On (b)(6) 2014, hysterosalpingogram revealed the left fallopian tube did not fill.There was successful closure of the left fallopian tube with the essure closure device.There are small linear defects located along the right and left sides of the endometrial cana.They were compatible with small areas of endometrial scarring or adhesions.Impression: 1.Patent right fallopian tube i the essure closure device was external to the tube and is free within the pelvis 2.Occluded left fallopian tube by the essure closure device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-aug-2018: quality safety evaluation of ptc.Incident : no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7220984
• MDR Text Key: 98282179
• Report Number: 2951250-2018-00474
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: B04850-INVALID
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 70