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

Model Number ESS305

Device Problems Biocompatibility (2886); Device Dislodged or Dislocated (2923)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pain (1994); Foreign Body In Patient (2687); Menorrhagia (4508); Pregnancy with a Contraceptive Device (4517); Insufficient Information (4580)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('left side coil was situated with pelvis and left fallopian tube was widely patent') in a female patient 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 "pregnancy with essure device".On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) with pelvic pain, abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia ("menorrhagia"), migraine ("migraine headache"), fatigue ("fatigue"), genital haemorrhage ("abnormal bleeding"), autoimmune disorder ("autoimmune") and hypersensitivity ("hypersensitivity") and was found to have a pregnancy with contraceptive device ("pregnancy with essure device").At the time of the report, the device dislocation, abdominal pain, genital haemorrhage, autoimmune disorder and hypersensitivity outcome was unknown and the back pain, menorrhagia, migraine and fatigue had not resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was not reported.The reporter considered abdominal pain, autoimmune disorder, back pain, device dislocation, fatigue, genital haemorrhage, hypersensitivity, menorrhagia, migraine and pregnancy with contraceptive device to be related to essure.The reporter commented: on (b)(6) 2011, plaintiff presented to the medical center for a laparoscopic tubal ligation.During this procedure, it was discovered that the essure coil was in the cul-de-sac and possibly attached to the colon.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - in (b)(6) 2010: results: positive.Pregnancy test urine - on (b)(6) 2010: results: positive.Diagnostic results: hysterosalpingogram on (b)(6) 2011: right fallopian tube was occluded while the essure coil from the left side was situated within the pelvis and the left fallopian tube was widely patent.Patent.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 28-aug-2020: pif received reporter information was added.New event genital bleeding, autoimmune disorder, hypersensitivity was added.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('left side coil was situated with pelvis and left fallopian tube was widely patent') in a female patient 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 "pregnancy with essure device".On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) with pelvic pain, abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia ("menorrhagia"), migraine ("migraine headache"), fatigue ("fatigue"), genital haemorrhage ("abnormal bleeding"), autoimmune disorder ("autoimmune") and hypersensitivity ("hypersensitivity") and was found to have a pregnancy with contraceptive device ("pregnancy with essure device").At the time of the report, the device dislocation, abdominal pain, genital haemorrhage, autoimmune disorder and hypersensitivity outcome was unknown and the back pain, menorrhagia, migraine and fatigue had not resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was not reported.The reporter considered abdominal pain, autoimmune disorder, back pain, device dislocation, fatigue, genital haemorrhage, hypersensitivity, menorrhagia, migraine and pregnancy with contraceptive device to be related to essure.No further causality assessment were provided for the product.The reporter commented: on (b)(6) 2011, plaintiff presented to the medical center for a laparoscopic tubal ligation.During this procedure, it was discovered that the essure coil was in the cul-de-sac and possibly attached to the colon.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - in (b)(6) 2010: results: positive.Pregnancy test urine - on (b)(6) 2010: results: positive.Diagnostic results: hysterosalpingogram on (b)(6) 2011: right fallopian tube was occluded while the essure coil from the left side was situated within the pelvis and the left fallopian tube was widely patent.Patent.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer, and describes the occurrence of device dislocation ('left side coil was situated with pelvis and left fallopian tube was widely patent').In an adult female patient 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 "pregnancy with essure device".On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) with pelvic pain, abdominal pain ("abdominal pain"), back pain ("back pain"), heavy menstrual bleeding ("menorrhagia"), migraine ("migraine headache"), fatigue ("fatigue"), genital haemorrhage ("abnormal bleeding"), autoimmune disorder ("autoimmune") and hypersensitivity ("hypersensitivity").And was found to have a pregnancy with contraceptive device ("pregnancy with essure device").At the time of the report, the device dislocation, abdominal pain, genital haemorrhage, autoimmune disorder and hypersensitivity outcome was unknown.And the back pain, heavy menstrual bleeding, migraine and fatigue had not resolved.Pregnancy related information: retrospective report, last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred, during the first, second and third trimesters.The pregnancy outcome was not reported.The reporter considered abdominal pain, autoimmune disorder, back pain, device dislocation, fatigue, genital haemorrhage, heavy menstrual bleeding, hypersensitivity, migraine and pregnancy with contraceptive device to be related to essure.The reporter commented: on (b)(6) 2011, plaintiff presented to the medical center for a laparoscopic tubal ligation.During this procedure, it was discovered, that the essure coil was in the cul-de-sac.And possibly attached to the colon.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test: on (b)(6) 2010, results: positive; pregnancy test urine: on (b)(6) 2010, results: positive.Diagnostic results: hysterosalpingogram on (b)(6)2011, right fallopian tube was occluded, while the essure coil from the left side was situated within the pelvis and the left fallopian tube was widely patent.Quality safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021, mr received: reporter added.Based on the available information.A review of our complaint records and other relevant data was conducted.Any new and reportable information that becomes available from our investigation, will be provided in a supplementary 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: 10519460
• MDR Text Key: 227640247
• Report Number: 2951250-2020-14126
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 06/15/2021

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 Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/16/2020; 06/09/2021
• Supplement Dates FDA Received: 09/16/2020; 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other