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); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Perforation (2001); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193)

Event Date 10/01/2009

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("ct scan showed the right essure coil free floating/ coil had migrated from the right fallopian tube to the left abdomen"), device breakage ("the inner coil of the right essure was not seen (at removal)"), pregnancy with contraceptive device ("she was pregnant") and genital haemorrhage ("bleeding") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".In (b)(6) 2009, the patient had essure inserted.In (b)(6) 2010, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("severe pelvic pain"), back pain ("back pain") and complication of device removal ("the inner coil of the right essure was not seen (at removal)").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (laparoscopic bilateral tubal ligation partial salpingectomy with extraction of essure device) and surgery (underwent laparoscopic cholecystectomy and retrieval of retained essure coil on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, pregnancy with contraceptive device, genital haemorrhage, pelvic pain, back pain and complication of device removal outcome was unknown.The pregnancy outcome was reported as elective abortion.The reporter considered back pain, complication of device removal, device breakage, device dislocation, genital haemorrhage, pelvic pain and pregnancy with contraceptive device to be related to essure.The reporter commented: a ct scan was ordered and showed the right essure coil free floating.On (b)(6) 2011, patient underwent a laparoscopic bilateral tubal ligation and partial salpingectomy with extraction of essure device.The outer coil of the right essure was removed from under the serosa of right comua.The inner coil of the right essure was not seen.A hysteroscopy was then performed in hopes to find the inner coil of the right essure device, however, no coils were seen inside the uterus.Then, on (b)(6) 2016, she underwent laparoscopic cholecystectomy and retrieval of retained essure coil.The coil had migrated from the right fallopian tube to the left abdomen and was removed from the abdomen.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: right essure coil free floating on (b)(6) 2010, she discovered that she was pregnant.On (b)(6) 2010, underwent a dilation and curettage.The outer coil of the right essure was removed from under the serosa of right comu.A hysteroscopy was then performed in hopes to find the inner coil of the right essure device.However, coils were seen inside the uterus.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.

Manufacturer Narrative

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("ct scan showed the right essure coil free floating/ coil had migrated from the right fallopian tube to the left abdomen"), device breakage ("the inner coil of the right essure was not seen (at removal)"), pregnancy with contraceptive device ("she was pregnant") and genital haemorrhage ("bleeding") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".In (b)(6) 2009, the patient had essure inserted.In (b)(6) 2010, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("severe pelvic pain"), back pain ("back pain") and complication of device removal ("the inner coil of the right essure was not seen (at removal)").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (laparoscopic bilateral tubal ligation partial salpingectomy with extraction of essure device) and surgery (underwent laparoscopic cholecystectomy and retrieval of retained essure coil on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, pregnancy with contraceptive device, genital haemorrhage, pelvic pain, back pain and complication of device removal outcome was unknown.The pregnancy outcome was reported as elective abortion.The reporter considered back pain, complication of device removal, device breakage, device dislocation, genital haemorrhage, pelvic pain and pregnancy with contraceptive device to be related to essure.The reporter commented: a ct scan was ordered and showed the right essure coil free floating.On (b)(6) 2011, patient underwent a laparoscopic bilateral tubal ligation and partial salpingectomy with extraction of essure device.The outer coil of the right essure was removed from under the serosa of right comua.The inner coil of the right essure was not seen.A hysteroscopy was then performed in hopes to find the inner coil of the right essure device, however, no coils were seen inside the uterus.Then, on (b)(6) 2016, she underwent laparoscopic cholecystectomy and retrieval of retained essure coil.The coil had migrated from the right fallopian tube to the left abdomen and was removed from the abdomen.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: right essure coil free floating on oct-2010, she discovered that she was pregnant.On (b)(6) 2010, underwent a dilation and curettage.The outer coil of the right essure was removed from under the serosa of right comu.A hysteroscopy was then performed in hopes to find the inner coil of the right essure device.However, coils were seen inside the uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-sep-2017: quality-safety evaluation of product technical complaint.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.

Manufacturer Narrative

Rospective pregnancy case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation (fallopian tube(s))"), device dislocation ("ct scan showed the right essure coil free floating/ coil had migrated from the right fallopian tube to the left abdomen/ migration of essure device location of device: abdomen/ failure to occlude (close) fallopian tube"), device breakage ("the inner coil of the right essure was not seen (at removal)"), pregnancy with contraceptive device ("she was pregnant/ pregnancy (with complications), pregnancy (termination)") and genital haemorrhage ("bleeding") in a 36-year-old female patient (gravida 5, para 2) who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" and device monitoring procedure not performed "essure confirmation test: not performed".The patient's past medical history included abdominoplasty.Previously administered products included for an unreported indication: birth control pill.Concurrent conditions included excessive skin.Concomitant products included bupropion (wellbutrin) from 2012 to 2016 and lamotrigine (lamictal) from 2012 to 2016.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and abdominal pain lower ("chronic aching pain in right lower quadrant of abdomen").In (b)(6) 2010, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2011, 1 year 3 months after insertion and 4 years 11 months after removal of essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("severe pelvic pain"), back pain ("back pain") and complication of device removal ("the inner coil of the right essure was not seen (at removal)").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (laparoscopic removal of essure), surgery (laparoscopic bilateral tubal ligation partial salpingectomy with extraction of essure device) and surgery (underwent laparoscopic cholecystectomy and retrieval of retained essure coil on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, device dislocation, device breakage, pregnancy with contraceptive device, genital haemorrhage, pelvic pain, back pain and complication of device removal outcome was unknown and the abdominal pain lower had resolved.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal pain lower, back pain, complication of device removal, device breakage, device dislocation, fallopian tube perforation, genital haemorrhage, pelvic pain and pregnancy with contraceptive device to be related to essure.The reporter commented: a ct scan was ordered and showed the right essure coil free floating.On (b)(6) 2011, patient underwent a laparoscopic bilateral tubal ligation and partial salpingectomy with extraction of essure device.The outer coil of the right essure was removed from under the serosa of right comua.The inner coil of the right essure was not seen.A hysteroscopy was then performed in hopes to find the inner coil of the right essure device, however, no coils were seen inside the uterus.Then, on (b)(6) 2016, she underwent laparoscopic cholecystectomy and retrieval of retained essure coil.The coil had migrated from the right fallopian tube to the left abdomen and was removed from the abdomen.She did not had any complications or problems that occurred at the time of essure placement procedure and essure removal procedure.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on an unknown date: right essure coil free floating on (b)(6) 2010, she discovered that she was pregnant.On (b)(6) 2010, underwent a dilation and curettage.The outer coil of the right essure was removed from under the serosa of right comu.A hysteroscopy was then performed in hopes to find the inner coil of the right essure device.However, coils were seen inside the uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-jun-2018: plaintiff fact sheet received.Reporter information, patient¿s demographic information, relevant history updated.Essure start date updated from (b)(6) 2009 to (b)(6) 2009.Events pregnancy (with complications), pregnancy (termination), migration of essure device location of device: abdomen, failure to occlude (close) fallopian tube were clubbed with previously reported events.Events fallopian tube perforation, abdominal pain lower, device monitoring procedure not performed were newly added.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: 6816269
• MDR Text Key: 83473607
• Report Number: 2951250-2017-03104
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2018

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 09/04/2017; 06/18/2018
• Supplement Dates FDA Received: 09/27/2017; 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LAMICTAL; WELLBUTRIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR