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

Model Number ESS305

Device Problems Break (1069); Migration or Expulsion of Device (1395); Device Inoperable (1663); Patient-Device Incompatibility (2682); Biocompatibility (2886); Migration (4003)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Reaction (2414); Abdominal Cramps (2543); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193)

Event Date 02/01/2014

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device breakage ("device breakage"), uterine perforation ("coils had migrated from her fallopian tubes and perforated other organs/migration of essure device location of device: uterus/ perforation (uterus)"), pregnancy with contraceptive device ("pregnant despite having the essure coils in her body for many years/pregnancy (with complications),") and haemorrhage in pregnancy ("device could have injured her unborn baby and may have caused internal bleeding") in a (b)(6) female patient who had essure (batch no.808912) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo essure confirmation" in (b)(6) 2011 and device ineffective "device ineffective".The patient's past medical history included multi gravida, parity 3 (dates of live births: (b)(6) 2010, (b)(6) 2011, (b)(6) 2015 (discrepancy noted, also listed in section ii-6 as (b)(6) 2016).), miscarriage (ga 8 weeks) in 1997 and stillbirth nos (ga 6-7 months) in 2001.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain ("pelvic pain"), abdominal pain ("severe abdominal pain"), menorrhagia ("persistent menstrual flow/abnormal bleeding (vaginal, menorrhagia),"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia),"), allergy to metals ("allergic or hypersensitivity reaction type: nickel/nickel allergy"), fatigue ("fatigue") and vulvovaginal pain ("pain").On in (b)(6) 2014, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2016, 4 years 5 months after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced haemorrhage in pregnancy (seriousness criterion medically significant), dysmenorrhoea ("cramping"), vaginal discharge ("discharge"), dyspareunia ("dyspareunia (painful sexual intercourse),"), headache ("migraines / headaches") and migraine ("migraines / headaches").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first, second and third trimesters of pregnancy.The patient was treated with surgery (laparoscopic bilateral removal of essure inserts, bilateral salpingectomy.).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, uterine perforation, pregnancy with contraceptive device, haemorrhage in pregnancy, pelvic pain, abdominal pain, menorrhagia, dysmenorrhoea, vaginal discharge, vaginal haemorrhage, allergy to metals, dyspareunia, headache, migraine, fatigue and vulvovaginal pain outcome was unknown.The pregnancy outcome was reported as a live birth of a child with health problems.3560g was the reported birth weight.The apgar scores were 9 and 9 (at 1 and 5 minutes).The reporter considered abdominal pain, allergy to metals, device breakage, dysmenorrhoea, dyspareunia, fatigue, haemorrhage in pregnancy, headache, menorrhagia, migraine, pelvic pain, pregnancy with contraceptive device, uterine perforation, vaginal discharge, vaginal haemorrhage and vulvovaginal pain to be related to essure.The reporter commented: this was then deployed and 2 loops of coil were visible after deployment.We then identified the left fallopian tube and an essure device was then inserted into the left fallopian tube, subsequently deployed and 3 loops of coil were then visible.On (b)(6) 2015:method of delivery ¿ vaginal.Ga at delivery: 39 2 wks, term.Condition: stable.Assessment: infant complications: none.Physical findings: within normal limits; respirations: appear normal.On (b)(6) 2015: baby is doing very well over all.Baby did lose some weight, so i did go over with mom to keep baby awake during feedings and waking up baby during night to eat.Discharge weight: (b)(6) and today¿s weight: (b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): gynaecological examination - in (b)(6) 2015: pregnant.Pregnancy test - on (b)(6) 2015: essure with positive pregnancy test.Ultrasound scan - on (b)(6) 2015: 8 week 3 day living intrauterine gestation after (b)(6) 2015: gynecological examination: coils had migrated from her fallopian tubes and perforated other organs.On (b)(6) 2015 , hysterosalpingogram - tube occlusion with appropriately positioned essure device on the right.Abnormally coiled essure device not conclusively within the tube with filling of the tube visualized beyond the cornual region with probable faint free spill in the left adnexa.Essure coil could not be located by sonogram.Elevated hgb a1c 1st trimester.Normal gtt.Group beta strep: positive.On (b)(6) 2015, pelvis x-ray: findings: devices appreciated.One seen in right pelvic potentially in pelvic gutter.Second essure device seen over left sacrum at approximately s1 level.Impression: 1.Two essure devices identified.The exact location (tubal versus peritoneal) cannot be determined on a plain x-ray study.On (b)(6) 2015, hysterosalpingogram : correct placement with tubal occlusions on the right side.It also shows probable essure perforation with incomplete occlusion on the left side.On (b)(6) 2016, pathology report: part 1.Additionally labeled "left and right fallopian tubes" are 2 (7 and 8.5 cm in length and averaging 0.4 cm in diameter) fimbriated fallopian tubes with purple-tan, predominantly smooth, serosa.One of the tubes is focally disrupted within the midportion of the tube.The cut surfaces reveal pinpoint-stellate lumina lined by tan, soft mucosa.Part 2.Additionally labeled "essure device" is a 2.5 x 2 x 0.3 cm aggregate of multiple synthetic metallic components which are focally coiled and focally surfaced by tan-pink, soft to rubbery and diffusely cauterized tissue.Microscopic diagnosis: left and right fallopian tubes, laparoscopic essure removal: fallopian tubes, 2, without significant pathologic abnormality.Full cross sections identified.Essure device, laparoscopic essure removal: specimen grossly consistent with essure device.Quality-safety evaluation of ptc: sample not available.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, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.Based on the available information a product quality defect could not be confirmed but is considered plausible.Based on the provided information the defect type corresponds to the following med dra llt: device ineffective.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events and the reported lack of efficacy cannot be totally excluded.However, a lack of efficacy and the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet and medical records received: reporters details added.Event added as abnormal bleeding (vaginal, menorrhagia), allergic or hypersensitivity reaction type: nickel/nickel allergy, device breakage, dyspareunia (painful sexual intercourse), migraines / headaches, vaginal pain, pregnancy (with complications)/ plaintiff that device could have injured her unborn baby and may have caused internal bleeding, did not undergo essure confirmation testing.Historical, concomitant condition and relevant lab data were 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

Rospective pregnancy case was reported by a lawyer and describes the occurrence of device breakage ("device breakage"), uterine perforation ("coils had migrated from her fallopian tubes and perforated other organs/migration of essure device location of device: uterus/ perforation (uterus)"), pregnancy with contraceptive device ("pregnant despite having the essure coils in her body for many years/pregnancy (with complications),") and haemorrhage in pregnancy ("device could have injured her unborn baby and may have caused internal bleeding") in a 33-year-old female patient who had essure (batch no.808912) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo essure confirmation" in september 2011 and device ineffective "device ineffective".The patient's past medical history included multigravida, multigravida (dates of live births: (b)(6) 2010, (b)(6) 2011, (b)(6) 2015 (discrepancy noted, also listed in section ii-6 as (b)(6) 2016, miscarriage (ga 8 weeks) in 1997 and stillbirth nos (ga 6-7 months) in 2001.In september 2011, the patient experienced pelvic pain ("pelvic pain"), abdominal pain ("severe abdominal pain"), menorrhagia ("persistent menstrual flow/abnormal bleeding (vaginal, menorrhagia),"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia),"), allergy to metals ("allergic or hypersensitivity reaction type: nickel/nickel allergy"), fatigue ("fatigue") and vulvovaginal pain ("pain").On (b)(6) 2011, the patient had essure inserted.In february 2014, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2016, 4 years 5 months after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced haemorrhage in pregnancy (seriousness criterion medically significant), dysmenorrhoea ("cramping"), vaginal discharge ("discharge"), dyspareunia ("dyspareunia (painful sexual intercourse),"), headache ("migraines / headaches") and migraine ("migraines / headaches").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (laparoscopic bilateral removal of essure inserts, bilateral salpingectomy.) and surgery (laparoscopic bilateral removal of essure inserts, bilateral salpingectomy.).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, uterine perforation, pregnancy with contraceptive device, haemorrhage in pregnancy, pelvic pain, abdominal pain, menorrhagia, dysmenorrhoea, vaginal discharge, vaginal haemorrhage, allergy to metals, dyspareunia, headache, migraine, fatigue and vulvovaginal pain outcome was unknown.The pregnancy outcome was reported as a live birth of a child with health problems.3560g was the reported birth weight.The apgar scores were 9 and 9 (at 1 and 5 minutes).The reporter considered abdominal pain, allergy to metals, device breakage, dysmenorrhoea, dyspareunia, fatigue, haemorrhage in pregnancy, headache, menorrhagia, migraine, pelvic pain, pregnancy with contraceptive device, uterine perforation, vaginal discharge, vaginal haemorrhage and vulvovaginal pain to be related to essure.The reporter commented: this was then deployed and 2 loops of coil were visible after deployment.We then identified the left fallopian tube and an essure device was then inserted into the left fallopian tube, subsequently deployed and 3 loops of coil were then visible.13sep2015:method of delivery ¿ vaginal.Ga at delivery: 39 2 wks, term condition: stable.Assessment: infant complications: none.Physical findings: within normal limits; respirations: appear normal.17sep2015: baby is doing very well over all.Baby did lose some weight, so i did go over with mom to keep baby awake during feedings and waking up baby during night to eat.Discharge weight: 7lbs 6oz and today¿s weight: 7lbs 5oz diagnostic results (normal ranges are provided in parenthesis if available): gynaecological examination - in february 2015: pregnant pregnancy test - on 9-feb-2015: essure with positive pregnancy test ultrasound scan - on 9-feb-2015: 8 week 3 day living intrauterine gestation after feb-2015: gynecological examination: coils had migrated from her fallopian tubes and perforated other organs.04-dec-2015 , hysterosalpingogram - tube occlusion with appropriately positioned essure device on the right.Abnormally coiled essure device not conclusively within the tube with filling of the tube visualized beyond the cornual region with probable faint free spill in the left adnexa.Essure coil could not be located by sonogram.Elevated hgb a1c 1st trimester.Normal gtt.Group beta strep: positive.15sep2015, pelvis x-ray: findings: devices appreciated.One seen in right pelvic potentially in pelvic gutter.Second essure device seen over left sacrum at approximately s1 level.Impression: 1.Two essure devices identified.The exact location (tubal versus peritoneal) cannot be determined on a plain x-ray study.17-dec-2015, hysterosalpingogram : correct placement with tubal occlusions on the right side.It also shows probable essure perforation with incomplete occlusion on the left side.21-mar-2016, pathology report: part 1.Additionally labeled "left and right fallopian tubes" are 2 (7 and 8.5 cm in length and averaging 0.4 cm in diameter) fimbriated fallopian tubes with purple-tan, predominantly smooth, serosa.One of the tubes is focally disrupted within the midportion of the tube.The cut surfaces reveal pinpoint-stellate lumina lined by tan, soft mucosa.Part 2.Additionally labeled "essure device" is a 2.5 x 2 x 0.3 cm aggregate of multiple synthetic metallic components which are focally coiled and focally surfaced by tan-pink, soft to rubbery and diffusely cauterized tissue.Microscopic diagnosis: 1.Left and right fallopian tubes, laparoscopic essure removal: fallopian tubes, 2, without significant pathologic abnormality.Full cross sections identified.2.Essure device, laparoscopic essure removal: specimen grossly consistent with essure device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-aug-2018: quality-safety evaluation of ptc (product technical problem ).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.

• 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: 7558242
• MDR Text Key: 109741816
• Report Number: 2951250-2018-02429
• 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: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2013
• Device Model Number: ESS305
• Device Lot Number: 808912
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR