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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Ectopic Pregnancy (1819); Pain (1994); Abdominal Distention (2601); Weight Changes (2607)

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") and ectopic pregnancy with contraceptive device ("ectopic pregnancy") 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 "device ineffective".In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), abdominal distension ("bloating") and weight increased ("weight gain").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 (to remove the essure implant).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, ectopic pregnancy with contraceptive device, abdominal distension and weight increased outcome was unknown.The reporter considered abdominal distension, ectopic pregnancy with contraceptive device, pelvic pain and weight increased to be related to essure.The reporter commented: need for additional surgery.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

Prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") and ectopic pregnancy with contraceptive device ("ectopic pregnancy") in an adult female patient who had essure (batch no.754207) 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 and parity 4 ((b)(6) 2014, (b)(6) 2010, (b)(6) 2000 and (b)(6) 1995).Concurrent conditions included irritable bowel syndrome and.Concomitant products included cabergoline since 2010 for pituitary tumour benign as well as alprazolam (xanax) and ibuprofen (motrin) since 2014.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), abdominal distension ("bloating"), weight increased ("weight gain"), anxiety ("psychological or psychiatric :problems condition: anxiety") and depression ("psychological or psychiatric :problems condition: depression").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 (to remove the essure implant).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain had resolved and the ectopic pregnancy with contraceptive device, abdominal distension, weight increased, anxiety and depression outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, anxiety, depression, ectopic pregnancy with contraceptive device, pelvic pain and weight increased to be related to essure.The reporter commented: need for additional surgery.The essure device was placed bilaterally.Four rings were visible inside the uterine cavity.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on (b)(6) 2010: total bilateral occlusion.Obstetric ultrasound exam: history ¿ positive pregnancy test, with continues bleeding and pain.Findings: ectopic pregnancy cannot be totally excluded here even though there is no flow and this may be original ectopic pregnancy that has lost its flow but the finding is nonspecific.Impression: empty uterus.Most recent follow-up information incorporated above includes: on 7-sep-2018: pfs received : new event: anxiety, depression and reporter, patient demographic information, product lot number, historical condition, concomitant medication and lab data 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

Prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), ectopic pregnancy with contraceptive device ("ectopic pregnancy") and abortion of ectopic pregnancy ("pregnancy (stillbirth or (miscarriage)") in an adult female patient who had essure (batch no.754207) 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 and parity 4 ((b)(6) 2014, (b)(6) 2010, (b)(6) 2000 and (b)(6) 1995).Concurrent conditions included irritable bowel syndrome.Concomitant products included cabergoline since 2010 for pituitary tumour benign as well as alprazolam (xanax) and ibuprofen (motrin) since 2014.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), abortion of ectopic pregnancy (seriousness criterion medically significant), abdominal distension ("bloating"), weight increased ("weight gain"), anxiety ("psychological or psychiatric :problems condition: anxiety") and depression ("psychological or psychiatric :problems condition: depression").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 the essure implant).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain had resolved and the ectopic pregnancy with contraceptive device, abortion of ectopic pregnancy, abdominal distension, weight increased, anxiety and depression outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, abortion of ectopic pregnancy, anxiety, depression, ectopic pregnancy with contraceptive device, pelvic pain and weight increased to be related to essure.The reporter commented: need for additional surgery.The essure device was placed bilaterally.Four rings were visible inside the uterine cavity diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: total bilateral occlusion obstetric ultrasound exam: history ¿ positive pregnancy test, with continues bleeding and pain.Findings: ectopic pregnancy cannot be totally excluded here even though there is no flow and this may be original ectopic pregnancy that has lost its flow but the finding is nonspecific.Impression: empty uterus.Most recent follow-up information incorporated above includes: on 7-sep-2018: correction mail received: new event abortion of ectopic pregnancy added.Second pregnancy case linked to this case.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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), ectopic pregnancy with contraceptive device ("ectopic pregnancy") and abortion of ectopic pregnancy ("pregnancy (stillbirth or (miscarriage)") in an adult female patient who had essure (batch no.754207) 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 medical history included multigravida and parity 4 ((b)(6) 2014, (b)(6) 2010, (b)(6) 2000 and (b)(6) 1995).Concurrent conditions included irritable bowel syndrome.Concomitant products included cabergoline since 2010 for pituitary tumour benign as well as alprazolam (xanax) and ibuprofen (motrin) since 2014.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abortion of ectopic pregnancy (seriousness criterion medically significant), abdominal distension ("bloating"), anxiety ("psychological or psychiatric :problems condition: anxiety") and depression ("psychological or psychiatric :problems condition: depression"), was found to have an ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required) and was found to have weight increased ("weight gain").The patient was treated with surgery (to remove the essure implant).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain had resolved and the ectopic pregnancy with contraceptive device, abortion of ectopic pregnancy, abdominal distension, weight increased, anxiety and depression outcome was unknown.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 trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, abortion of ectopic pregnancy, anxiety, depression, ectopic pregnancy with contraceptive device, pelvic pain and weight increased to be related to essure.The reporter commented: need for additional surgery.The essure device was placed bilaterally.Four.Rings were visible inside the uterine cavity.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: results: total bilateral occlusion.Diagnostic results: obstetric ultrasound exam: history ¿ positive pregnancy test, with continues bleeding and pain.Findings: ectopic pregnancy cannot be totally excluded here even though there is no flow and this may be original ectopic pregnancy that has lost its flow but the finding is nonspecific.Impression: empty uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-nov-2018: quality-safety evaluation of ptc.Incident: we received a lot number/returned sample in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, 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: 7295464
• MDR Text Key: 100892448
• Report Number: 2951250-2018-00849
• 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,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2013
• Device Model Number: ESS305
• Device Lot Number: 754207
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CABERGOLINE; CABERGOLINE; CABERGOLINE; CABERGOLINE; MOTRIN; MOTRIN; MOTRIN; OTHER THERAPEUTIC PRODUCTS; XANAX; XANAX; XANAX; XANAX
• Patient Outcome(s): Other; Required Intervention