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

Model Number ESS305

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Pain (1994); Perforation (2001); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193)

Event Type  Injury  

Event Description

This prospective pregnancy case was reported by a lawyer and describes the occurrence of perforation ("perforation"), device dislocation ("migration"), device breakage ("fracturing") and pregnancy with contraceptive device ("pregnancy") in a female patient who had essure inserted.Other product or product use issues identified: device ineffective "device ineffective".In (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required) and pregnancy with contraceptive device (seriousness criterion medically significant).Last menstrual period was not provided.The patient was treated with surgery (removal of essure).Essure was removed on (b)(6) 2013.At the time of the report, the perforation, device dislocation, device breakage and pregnancy with contraceptive device outcome was unknown.The pregnancy outcome was not reported.The reporter considered device breakage, device dislocation, perforation and pregnancy with contraceptive device to be related to essure.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

Spective pregnancy case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation"), device dislocation ("migration"), device breakage ("fracturing/the essure device was removed from the uterine fundus in 2 pieces") and pregnancy with contraceptive device ("pregnancy/pregnancy (no complications)") in an adult female patient who had essure (batch no.84152b-inv) 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".The patient's past medical history included multigravida, parity 3 and miscarriage.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant) and abdominal pain lower ("lower abdominal pain").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 naproxen, surgery (removal of essure/(bilateral salpingectomy)), surgery (removal of essure/(bilateral salpingectomy)) and surgery (removal of essure/(bilateral salpingectomy).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation, device dislocation, device breakage, pregnancy with contraceptive device and abdominal pain lower outcome was unknown.The pregnancy outcome was not reported.The reporter considered abdominal pain lower, device breakage, device dislocation, fallopian tube perforation and pregnancy with contraceptive device to be related to essure.The reporter commented: there is a discrepancy in product stop date earlier it was given (b)(6) 2013 and in fu it was given.(b)(6) 2016 diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2012: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 29-aug-2018: update of information (batch not valid).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

Spective pregnancy case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation"), device dislocation ("migration"), device breakage ("fracturing/the essure device was removed from the uterine fundus in 2 pieces") and pregnancy with contraceptive device ("pregnancy/pregnancy (no complications)") in an adult female patient who had essure (batch no.84152b) 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".The patient's past medical history included multigravida, parity 3 and miscarriage.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant) and abdominal pain lower ("lower abdominal pain").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first trimester of pregnancy.The patient was treated with naproxen, surgery (removal of essure/(bilateral salpingectomy)),.Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation, device dislocation, device breakage, pregnancy with contraceptive device and abdominal pain lower outcome was unknown.The pregnancy outcome was not reported.The reporter considered abdominal pain lower, device breakage, device dislocation, fallopian tube perforation and pregnancy with contraceptive device to be related to essure.The reporter commented: there is a discrepancy in product stop date earlier it was given (b)(6) 2013 and in fu it was given (b)(6) 2016.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2012: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 20-jun-2018: plaintiff fact sheet was received - reporter and patient demographic added.The following events were provided: lower abdominal pain.Lot number 84152b 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

Spective pregnancy case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation"), device dislocation ("migration"), device breakage ("fracturing/the essure device was removed from the uterine fundus in 2 pieces") and pregnancy with contraceptive device ("pregnancy/pregnancy (no complications)") in an adult female patient (gravida 5, para 3) who had essure (batch no.84152b-inv) 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".The patient's past medical history included multigravida, parity 3, miscarriage and miscarriage.Previously administered products included for an unreported indication: oral contraceptive nos and iud nos.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant) and abdominal pain lower ("lower abdominal pain").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 naproxen, surgery (removal of essure/(bilateral salpingectomy)), surgery (removal of essure/(bilateral salpingectomy)) and surgery (removal of essure/(bilateral salpingectomy).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 and abdominal pain lower outcome was unknown.The pregnancy outcome was reported as a live birth of multiple neonates with no information on the childrens' health.The reporter considered abdominal pain lower, device breakage, device dislocation, fallopian tube perforation and pregnancy with contraceptive device to be related to essure.The reporter commented: there is a discrepancy in product stop date earlier it was given (b)(6) 2013 and in fu it was given (b)(6) 2016.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2012: total bilateral occlusion most recent follow-up information incorporated above includes: on 5-oct-2018: plaintiff fact sheet received.Pregnancy outcome updated to live birth.Historical & concomitant conditions drugs were added.Product , patient & reporter information updated.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: 7056222
• MDR Text Key: 92867387
• Report Number: 2951250-2017-08005
• 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,Followup
• Report Date: 10/18/2018

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
• Device Lot Number: 84152B-INV
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 06/20/2018; 08/29/2018; 10/05/2018
• Supplement Dates FDA Received: 07/18/2018; 08/30/2018; 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention