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

Model Number ESS305

Device Problems Break (1069); Fracture (1260)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193)

Event Date 02/09/2012

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device breakage ("fracturing of the implant"), pregnancy with contraceptive device ("pregnancy") and genital haemorrhage ("severe clotting") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "pregnancy".In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("chronic pelvic pain / pain"), dyspareunia ("painful intercourse"), abdominal pain lower ("lower abdominal pain") and back pain ("lower back 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 surgery (to remove essure implant).Essure was removed in (b)(6) 2012.At the time of the report, the device breakage, pregnancy with contraceptive device, genital haemorrhage, pelvic pain, dyspareunia, abdominal pain lower and back pain outcome was unknown.The pregnancy outcome was not reported.The reporter considered abdominal pain lower, back pain, device breakage, dyspareunia, genital haemorrhage, pelvic pain 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

Rospective pregnancy case was reported by a lawyer and describes the occurrence of device breakage ("fracturing of the implant"), pregnancy with contraceptive device ("pregnancy") and genital haemorrhage ("severe clotting") in a 36-year-old female patient who had essure (batch no.740665) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "couldn't remove both coils", device monitoring procedure not performed "essure confirmation test(s) conducted, specify- no" and device ineffective "pregnancy".The patient's past medical history included multi gravida and parity 3 ((b)(6) 2001, (b)(6) 2010, (b)(6) 2012).In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("chronic pelvic pain / pain"), dyspareunia ("painful intercourse"), abdominal pain lower ("lower abdominal pain"), back pain ("lower back pain"), urinary tract disorder ("urinary problems or changes"), bladder disorder ("bladder problems or changes"), fatigue ("fatigue") and abdominal pain ("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 surgery (supracervical hysterectomy (uterus only)).Essure was removed on (b)(6) 2012.At the time of the report, the device breakage, pregnancy with contraceptive device, genital haemorrhage, pelvic pain, dyspareunia, abdominal pain lower, back pain, urinary tract disorder, bladder disorder, fatigue and abdominal pain outcome was unknown.The pregnancy outcome was reported as a live birth of a healthy child.The reporter considered abdominal pain, abdominal pain lower, back pain, bladder disorder, device breakage, dyspareunia, fatigue, genital haemorrhage, pelvic pain, pregnancy with contraceptive device and urinary tract disorder to be related to essure.The reporter commented: date(s) of removal: (b)(6) 2012, (b)(6) 2012.(healthcare provider) couldn't remove both coils.Most recent follow-up information incorporated above includes: on 13-jun-2018: plaintiff fact sheet and medical records received.Reporters added.Plaintiff demographics and relevant history added.Essure lot number added.New events bladder problems or changes, urinary problems or changes, fatigue, abdominal pain, essure confirmation test(s) not conducted and couldn't remove both coils were added and pregnancy outcome updated.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 ("fracturing of the implant"), pregnancy with contraceptive device ("pregnancy") and genital haemorrhage ("severe clotting") in a 36-year-old female patient who had essure (batch no.740665) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "couldn't remove both coils", device monitoring procedure not performed "essure confirmation test(s) conducted, specify- no" and device ineffective "pregnancy".The patient's past medical history included multi gravida and parity 3 (b)(6) 2001, (b)(6) 2010, (b)(6) 2012).In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("chronic pelvic pain / pain"), dyspareunia ("painful intercourse"), abdominal pain lower ("lower abdominal pain"), back pain ("lower back pain"), urinary tract disorder ("urinary problems or changes"), bladder disorder ("bladder problems or changes"), fatigue ("fatigue") and abdominal pain ("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 surgery (supracervical hysterectomy (uterus only)).Essure was removed on (b)(6) 2012.At the time of the report, the device breakage, pregnancy with contraceptive device, genital haemorrhage, pelvic pain, dyspareunia, abdominal pain lower, back pain, urinary tract disorder, bladder disorder, fatigue and abdominal pain outcome was unknown.The pregnancy outcome was reported as a live birth of a healthy child.The reporter considered abdominal pain, abdominal pain lower, back pain, bladder disorder, device breakage, dyspareunia, fatigue, genital haemorrhage, pelvic pain, pregnancy with contraceptive device and urinary tract disorder to be related to essure.The reporter commented: date(s) of removal: ??-feb-2012, 21mar2012.(healthcare provider) couldn't remove both coils.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-sep-2018: quality safety evaluation of ptc (product technical complaint).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 ("fracturing of the implant"), pregnancy with contraceptive device ("pregnancy") and genital haemorrhage ("severe clotting") in a 36-year-old female patient who had essure (batch no.740665) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "couldn't remove both coils", device monitoring procedure not performed "essure confirmation test(s) conducted, specify- no" and device ineffective "pregnancy".The patient's past medical history included multi gravida and parity 3 ((b)(6) 2001, (b)(6) 2010, (b)(6) 2012).In 2010, the patient experienced pelvic pain ("chronic pelvic pain / pain"), dyspareunia ("painful intercourse/ dyspareunia"), fatigue ("fatigue") and urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti").On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2012, 1 year 5 months after insertion of essure, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("lower abdominal pain"), back pain ("lower back pain"), urinary tract disorder ("urinary problems or changes"), bladder disorder ("bladder problems or changes") and abdominal pain ("abdominal pain").Last menstrual period and estimated date of delivery were not provided.The patient was treated with surgery (supracervical hysterectomy (uterus only)).Essure was removed on (b)(6) 2012.At the time of the report, the device breakage, pregnancy with contraceptive device, genital haemorrhage, pelvic pain, dyspareunia, abdominal pain lower, back pain, urinary tract disorder, bladder disorder, fatigue and abdominal pain outcome was unknown and the urinary tract infection was resolving.The pregnancy outcome was reported as a live birth of a healthy child.The reporter considered abdominal pain, abdominal pain lower, back pain, bladder disorder, device breakage, dyspareunia, fatigue, genital haemorrhage, pelvic pain, pregnancy with contraceptive device, urinary tract disorder and urinary tract infection to be related to essure.The reporter commented: date(s) of removal: (b)(6) 2012, (b)(6) 2012.(healthcare provider) couldn't remove both coils.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-oct-2018: reporters added.On (b)(6) 2010, she implanted essure (previously reported as jul-2010).Added events infection (bladder/ urinary tract/vaginal) type: uti.Updated onset date of events.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: 7056362
• MDR Text Key: 92867239
• Report Number: 2951250-2017-08334
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/23/2018

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 Expiration Date: 05/01/2013
• Device Model Number: ESS305
• Device Lot Number: 740665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 06/13/2018; 09/20/2018; 10/16/2018
• Supplement Dates FDA Received: 07/13/2018; 09/21/2018; 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR