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); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Expulsion (2933); Material Protrusion/Extrusion (2979); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Headache (1880); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

This prospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("migrated out of the tube, and is protruding inside the uterus on approximately 2 to 3 cm") and pregnancy with contraceptive device ("pregnant with essure") in a (b)(6) 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 "device ineffective".On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2017, 4 years 3 months after insertion of essure, the patient experienced abdominal pain ("severe and constant abdominal pain") and dyspareunia ("dyspareunia").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, pregnancy with contraceptive device (seriousness criterion medically significant), migraine ("migraines") and fatigue ("fatigue").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 (total laparoscopic hysterectomy and bilateral salpingectomy, with preservation of both ovaries).Essure was removed.At the time of the report, the device dislocation, abdominal pain, dyspareunia, migraine and fatigue had resolved and the pregnancy with contraceptive device outcome was unknown.The pregnancy outcome was not reported.The reporter considered abdominal pain, device dislocation, dyspareunia, fatigue, migraine and pregnancy with contraceptive device to be related to essure.The reporter commented: on (b)(6) 2013, she underwent the essure procedure under local anesthesia.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - on (b)(6) 2017: right coil in correct position,left not visualized (b)(6) 2017: total laparoscopic hysterectomy and bilateral salpingectomy, with preservation of both ovaries: operative report: the right essure implant has migrated out of the tube and is protruding inside the uterus on approximately 2 to 3 cm.Pathology report also noted that within the right cornu is a partially-stretched silver coil-shaped essure medical device (5.5cm) which has not grossly perforated the uterus.Further company follow-up with the consumer is not possible.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 spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migrated out of the tube, and is protruding inside the uterus on approximately 2 to 3 cm') in a 30-year-old 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 "device ineffective".On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2017, the patient experienced abdominal pain ("severe and constant abdominal pain") and dyspareunia ("dyspareunia"), 4 years 3 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, migraine ("migraines"), fatigue ("fatigue") and genital haemorrhage ("abnormal bleeding") and was found to have a pregnancy with contraceptive device ("pregnant with essure").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy, with preservation of both ovaries).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, abdominal pain, dyspareunia, migraine and fatigue had resolved and the pregnancy with contraceptive device and genital haemorrhage outcome was unknown.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered abdominal pain, device dislocation, dyspareunia, fatigue, genital haemorrhage, migraine and pregnancy with contraceptive device to be related to essure.The reporter commented: on (b)(6) 2013, she underwent the essure procedure under local anestesia.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - on (b)(6) 2017: results: right coil in correct position,left not visualized.Diagnostic results: (b)(6) 2017: total laparoscopic hysterectomy and bilateral salpingectomy, with preservation of both ovaries: operative report: the right essure implant has migrated out of the tube and is protruding inside the uterus on approximately 2 to 3 cm.Pathology report also noted that within the right cornu is a partially-stretched silver coil-shaped essure medical device (5.5cm) which has not grossly perforated the uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer is not possible.Most recent follow-up information incorporated above includes: on 18-sep-2020: quality-safety evaluation of product technical complaint.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 ('migrated out of the tube, and is protruding inside the uterus on approximately 2 to 3 cm') in a 30-year-old 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 "device ineffective".On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2017, the patient experienced abdominal pain ("severe and constant abdominal pain") and dyspareunia ("dyspareunia"), 4 years 3 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, migraine ("migraines"), fatigue ("fatigue") and genital haemorrhage ("abnormal bleeding") and was found to have a pregnancy with contraceptive device ("pregnant with essure").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy, with preservation of both ovaries).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, abdominal pain, dyspareunia, migraine and fatigue had resolved and the pregnancy with contraceptive device and genital haemorrhage outcome was unknown.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered abdominal pain, device dislocation, dyspareunia, fatigue, genital haemorrhage, 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) 2013, she underwent the essure procedure under local anestesia.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - on (b)(6) 2017: results: right coil in correct position,left not visualized.Diagnostic results: (b)(6) 2017: total laparoscopic hysterectomy and bilateral salpingectomy, with preservation of both ovaries: operative report: the right essure implant has migrated out of the tube and is protruding inside the uterus on approximately 2 to 3 cm.Pathology report also noted that within the right cornu is a partially-stretched silver coil-shaped essure medical device (5.5cm) which has not grossly perforated the uterus.Quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the consumer is not possible.Most recent follow-up information incorporated above includes: on 28-aug-2020: pif received.Event abnormal bleeding added.Event pregnancy with contraceptive device seriousness criteria updated as non-serious.Based on the available information, a review of our complaint records and other relevant data will be 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 breakage ('small metal piece in the left cornua is still not visible / very tiny small piece of metal'), embedded device ('embedded into the cornua and likely into the myometrium') and device dislocation ('migrated out of the tube, and is protruding inside the uterus on approximately 2 to 3 cm') in a 30-year-old female patient who had essure (batch no.12570405) 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".On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2017, the patient experienced abdominal pain ("severe and constant abdominal pain") and dyspareunia ("dyspareunia"), 4 years 3 months after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, device expulsion ("device expulsion"), migraine ("migraines"), fatigue ("fatigue") and genital haemorrhage ("abnormal bleeding") and was found to have a pregnancy with contraceptive device ("pregnant with essure").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy, with preservation of both ovaries).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, embedded device, pregnancy with contraceptive device and genital haemorrhage outcome was unknown and the device dislocation, abdominal pain, dyspareunia, migraine and fatigue had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered abdominal pain, device breakage, device dislocation, device expulsion, dyspareunia, embedded device, fatigue, genital haemorrhage, migraine and pregnancy with contraceptive device to be related to essure.The reporter commented: on (b)(6) 2013, she underwent the essure procedure under local anestesia.4-5 coils visible on the right and implant is right at the tubal entrance on the left.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - on (b)(6) 2017: results: right coil in correct position,left not visualized.Diagnostic results: (b)(6) 2017: total laparoscopic hysterectomy and bilateral salpingectomy, with preservation of both ovaries: operative report: the right essure implant has migrated out of the tube and is protruding inside the uterus on approximately 2 to 3 cm.Pathology report also noted that within the right cornu is a partially-stretched silver coil-shaped essure medical device (5.5cm) which has not grossly perforated the uterus.Further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 16-jul-2021: mr received: lot number added.Event added: very tiny small piece of metal, embedded into the cornua and device expulsion.Reporter information, patient demographics, product indication and rcc note were added.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('small metal piece in the left cornua is still not visible / very tiny small piece of metal'), embedded device ('embedded into the cornua and likely into the myometrium') and device dislocation ('migrated out of the tube, and is protruding inside the uterus on approximately 2 to 3 cm') in a 30-year-old female patient who had essure (batch no.12570405) 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".On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2017, the patient experienced abdominal pain ("severe and constant abdominal pain") and dyspareunia ("dyspareunia"), 4 years 3 months after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, device expulsion ("device expulsion"), migraine ("migraines"), fatigue ("fatigue") and genital haemorrhage ("abnormal bleeding") and was found to have a pregnancy with contraceptive device ("pregnant with essure").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy, with preservation of both ovaries).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, embedded device, pregnancy with contraceptive device and genital haemorrhage outcome was unknown and the device dislocation, abdominal pain, dyspareunia, migraine and fatigue had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered abdominal pain, device breakage, device dislocation, device expulsion, dyspareunia, embedded device, fatigue, genital haemorrhage, migraine and pregnancy with contraceptive device to be related to essure.The reporter commented: on (b)(6) 2013, she underwent the essure procedure under local anestesia.4-5 coils visible on the right and implant is right at the tubal entrance on the left.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - on (b)(6) 2017: results: right coil in correct position, left not visualized.Diagnostic results: (b)(6) 2017: total laparoscopic hysterectomy and bilateral salpingectomy, with preservation of both ovaries: operative report: the right essure implant has migrated out of the tube and is protruding inside the uterus on approximately 2 to 3 cm.Pathology report also noted that within the right cornu is a partially-stretched silver coil-shaped essure medical device (5.5cm) which has not grossly perforated the uterus.Lot number:12570405 manufacturing date:2013-01 expiration date:2016-01.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 4-aug-2021: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this 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: 7381064
• MDR Text Key: 103806358
• Report Number: 2951250-2018-01348
• 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,Followup
• Report Date: 08/04/2021

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 Expiration Date: 01/01/2016
• Device Model Number: ESS305
• Device Lot Number: 12570405
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 08/28/2020; 09/18/2020; 07/16/2021; 08/04/2021
• Supplement Dates FDA Received: 09/11/2020; 09/25/2020; 07/28/2021; 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR