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

Model Number ESS305

Device Problems Break (1069); Malposition of Device (2616); Material Protrusion/Extrusion (2979); Migration (4003)

Patient Problems Abdominal Pain (1685); Arthritis (1723); Cyst(s) (1800); Emotional Changes (1831); Headache (1880); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Miscarriage (1962); Swelling (2091); Hot Flashes/Flushes (2153); Anxiety (2328); Heavier Menses (2666); Foreign Body In Patient (2687); Pregnancy (3193); Cancer (3262); Constipation (3274)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("malposition of essure device/expulsion of essure device"), genital haemorrhage ("heavy bleeding"), abortion spontaneous ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy"), benign hydatidiform mole ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy") and pregnancy with contraceptive device ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy") in a (b)(6) female patient who had essure (batch no.699884) 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/failure to occlude (close) fallopian tube(s)/ left tube was found to be open" in 2014.The patient's past medical history included pregnancy termination in 2013, headache, vaginal discharge and ovarian cyst.Concurrent conditions included lumbago, abdominal pain, vaginal odor, bacterial vaginosis, eye swelling, sinusitis, tooth pain, migraine, headache, hypertension, menorrhagia, arthritis, paratubal cyst, multiparous, anxiety, ovarian cancer and constipation.On (b)(6) 2010, the patient had essure inserted.In 2010, the patient experienced female sexual dysfunction ("apareunia").In 2012, the patient experienced hot flush ("hot sweats") and mood swings ("mood swings").On (b)(6) 2014, 4 years after insertion of essure, the patient experienced benign hydatidiform mole (seriousness criterion medically significant) and pregnancy with contraceptive device (seriousness criterion medically significant).In 2014, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required).In 2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced vaginal infection ("vaginal infection").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), back pain ("back pain"), abdominal pain ("abdominal pain") and headache ("headaches").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 (essure removal), surgery (hydrothermal ablation was done on (b)(6) 2014), surgery (dilation and curetage) and surgery (dilation and curetage).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, abortion spontaneous, benign hydatidiform mole, pregnancy with contraceptive device, female sexual dysfunction, hot flush, mood swings, vaginal infection, pelvic pain and back pain outcome was unknown and the genital haemorrhage, abdominal pain and headache had resolved.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal pain, abortion spontaneous, back pain, benign hydatidiform mole, device dislocation, female sexual dysfunction, genital haemorrhage, headache, hot flush, mood swings, pelvic pain, pregnancy with contraceptive device and vaginal infection to be related to essure.The reporter commented: the plaintiff experienced one previous pregnancy episodes in 2013 captured under the cases (b)(4).Essure was removed on (b)(6) 2014 by bilateral salpingectomy.After placement, there were 5 coils protruding from the ostium on the right and 9 coils protruding on the left.Essure was removed from the abdominal cavity.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 35.8 kg/sqm.Pregnancy test urine - on (b)(6) 2010: positive on (b)(6) 2014, patient learned that she was pregnant.(b)(6) 2014, us pelvis transabdominal and transvaginal: the endometrial cavity is distended with heterogeneous, mixed hypo-and hyperechoic material present.Differential considerations include retained products of conception and/or endometrial blood.Had leep 2000 states her pap always abnormal.Assessment and plan: pap smear with low grade squamous intraepithelial lesion.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs and mr received.New reporter added.New events added- apareunia, hot sweats, mood swings, malposition of essure device, vaginal infection, pain, heavy bleeding, back pain and abdominal pain.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 retrospective pregnancy case was reported by a lawyer and describes the occurrence of device expulsion ("malposition of essure device/expulsion of essure device"), genital haemorrhage ("heavy bleeding"), abortion spontaneous ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy"), benign hydatidiform mole ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy") and pregnancy with contraceptive device ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy") in a 36-year-old female patient who had essure (batch no.699884) 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/failure to occlude (close) fallopian tube(s)/ left tube was found to be open" in 2014.The patient's past medical history included pregnancy termination in 2013, headache, vaginal discharge and ovarian cyst.Concurrent conditions included lumbago, abdominal pain, vaginal odor, bacterial vaginosis, eye swelling, sinusitis, tooth pain, migraine, headache, hypertension, menorrhagia, arthritis, paratubal cyst, multiparous, anxiety, ovarian cancer and constipation.On (b)(6) 2010, the patient had essure inserted.In 2010, the patient experienced female sexual dysfunction ("apareunia").In 2012, the patient experienced hot flush ("hot sweats"), hyperhidrosis ("hot sweats") and mood swings ("mood swings").On (b)(6) 2014, 4 years after insertion of essure, the patient experienced benign hydatidiform mole (seriousness criterion medically significant) and pregnancy with contraceptive device (seriousness criterion medically significant).In 2014, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required).In 2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced vaginal infection ("vaginal infection").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), back pain ("back pain"), abdominal pain ("abdominal pain") and headache ("headaches").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 (essure removal), surgery (hydrothermal ablation was done on (b)(6) 2014) and surgery (dilation and curetage).Essure was removed on (b)(6) 2014.At the time of the report, the device expulsion, abortion spontaneous, benign hydatidiform mole, pregnancy with contraceptive device, female sexual dysfunction, hot flush, hyperhidrosis, mood swings, vaginal infection, pelvic pain and back pain outcome was unknown and the genital haemorrhage, abdominal pain and headache had resolved.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal pain, abortion spontaneous, back pain, benign hydatidiform mole, device expulsion, female sexual dysfunction, genital haemorrhage, headache, hot flush, hyperhidrosis, mood swings, pelvic pain, pregnancy with contraceptive device and vaginal infection to be related to essure.The reporter commented: the plaintiff experienced one previous pregnancy episodes in 2013 captured under the cases (b)(4).Essure was removed on (b)(6) 2014 by bilateral salpingectomy.After placement, there were 5 coils protruding from the ostium on the right and 9 coils protruding on the left.Essure was removed from the abdominal cavity.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 35.8 kg/sqm.Pregnancy test urine - on (b)(6) 2010: positive.On (b)(6) 2014, patient learned that she was pregnant.On (b)(6) 2014, us pelvis transabdominal and transvaginal: the endometrial cavity is distended with heterogeneous, mixed hypo-and hyperechoic material present.Differential considerations include retained products of conception and/or endometrial blood.Had leep 2000 states her pap always abnormal.Assessment and plan: pap smear with low grade squamous intraepithelial lesion.Most recent follow-up information incorporated above includes: on 21-jun-2018: coding correction: after query, event "hot sweats" was identified as multiple concepts.Therefore, event was separated in two different events "hot flushes" and "sweats".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 device expulsion ("malposition of essure device/expulsion of essure device"), genital haemorrhage ("heavy bleeding"), abortion spontaneous ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy"), benign hydatidiform mole ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy") and pregnancy with contraceptive device ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy") in a 36-year-old female patient who had essure (batch no.699884) 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/failure to occlude (close) fallopian tube(s)/ left tube was found to be open" in 2014.The patient's past medical history included pregnancy termination in 2013, headache, vaginal discharge and ovarian cyst.Concurrent conditions included lumbago, abdominal pain, vaginal odor, bacterial vaginosis, eye swelling, sinusitis, tooth pain, migraine, headache, hypertension, menorrhagia, arthritis, paratubal cyst, multiparous, anxiety, ovarian cancer and constipation.On (b)(6) 2010, the patient had essure inserted.In 2010, the patient experienced female sexual dysfunction ("apareunia").In 2012, the patient experienced hot flush ("hot sweats"), hyperhidrosis ("hot sweats") and mood swings ("mood swings").On (b)(6) 2014, 4 years after insertion of essure, the patient experienced benign hydatidiform mole (seriousness criterion medically significant) and pregnancy with contraceptive device (seriousness criterion medically significant).In 2014, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required).In 2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced vaginal infection ("vaginal infection").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), back pain ("back pain"), abdominal pain ("abdominal pain") and headache ("headaches").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 (essure removal), surgery (hydrothermal ablation was done on (b)(6) 2014), surgery (dilation and curetage) and surgery (dilation and curetage).Essure was removed on (b)(6) 2014.At the time of the report, the device expulsion, abortion spontaneous, benign hydatidiform mole, pregnancy with contraceptive device, female sexual dysfunction, hot flush, hyperhidrosis, mood swings, vaginal infection, pelvic pain and back pain outcome was unknown and the genital haemorrhage, abdominal pain and headache had resolved.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal pain, abortion spontaneous, back pain, benign hydatidiform mole, device expulsion, female sexual dysfunction, genital haemorrhage, headache, hot flush, hyperhidrosis, mood swings, pelvic pain, pregnancy with contraceptive device and vaginal infection to be related to essure.The reporter commented: the plaintiff experienced one previous pregnancy episodes in 2013 captured under the cases (b)(4).Essure was removed on (b)(6) 2014 by bilateral salpingectomy.After placement, there were 5 coils protruding from the ostium on the right and 9 coils protruding on the left.Essure was removed from the abdominal cavity.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 35.8 kg/sqm.Pregnancy test urine - on (b)(6) 2010: positive on (b)(6) 2014, patient learned that she was pregnant.On (b)(6) 2014, us pelvis transabdominal and transvaginal: the endometrial cavity is distended with heterogeneous, mixed hypo-and hyperechoic material present.Differential considerations include retained products of conception and/or endometrial blood.Had leep 2000 states her pap always abnormal.Assessment and plan: pap smear with low grade squamous intraepithelial lesion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-jul-2018: quality-safety evaluation of 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 expulsion ("malposition of essure device/expulsion of essure device"), genital haemorrhage ("heavy bleeding"), abortion spontaneous ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy"), benign hydatidiform mole ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy") and pregnancy with contraceptive device ("pregnancy (termination)/ pregnancy (stillbirth or miscarriage) blighted ovum and nonviable pregnancy/ molar pregnancy") in a 36-year-old female patient who had essure (batch no.699884) 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/failure to occlude (close) fallopian tube(s)/ left tube was found to be open" in 2014.The patient's past medical history included pregnancy termination in 2013, headache, vaginal discharge, ovarian cyst and pregnancy with contraceptive device in 2013.Concurrent conditions included lumbago, abdominal pain, vaginal odor, bacterial vaginosis, eye swelling, sinusitis, tooth pain, migraine, headache, hypertension, menorrhagia, arthritis, paratubal cyst, multiparous, anxiety, ovarian cancer and constipation.On (b)(6)2010, the patient had essure inserted.In 2010, the patient experienced female sexual dysfunction ("apareunia").In 2012, the patient experienced hot flush ("hot sweats"), hyperhidrosis ("hot sweats") and mood swings ("mood swings").On (b)(6)2014, 4 years after insertion of essure, the patient experienced benign hydatidiform mole (seriousness criterion medically significant) and pregnancy with contraceptive device (seriousness criterion medically significant).In 2014, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required).In 2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).On (b)(6)2015, the patient experienced vaginal infection ("vaginal infection").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), back pain ("back pain"), abdominal pain ("abdominal pain") and headache ("headaches").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 (essure removal), surgery (hydrothermal ablation was done on(b)(6)2014), surgery (dilation and curetage) and surgery (dilation and curetage).Essure was removed on (b)(6)-2014.At the time of the report, the device expulsion, abortion spontaneous, benign hydatidiform mole, pregnancy with contraceptive device, female sexual dysfunction, hot flush, hyperhidrosis, mood swings, vaginal infection, pelvic pain and back pain outcome was unknown and the genital haemorrhage, abdominal pain and headache had resolved.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal pain, abortion spontaneous, back pain, benign hydatidiform mole, device expulsion, female sexual dysfunction, genital haemorrhage, headache, hot flush, hyperhidrosis, mood swings, pelvic pain, pregnancy with contraceptive device and vaginal infection to be related to essure.The reporter commented: the plaintiff experienced one previous pregnancy episode in 2013 captured under the case 2016-215217 and an ectopic pregnancy with essure under the case 2018-117962.Essure was removed on (b)(6)2014 by bilateral salpingectomy.After placement, there were 5 coils protruding from the ostium on the right and 9 coils protruding on the left.Essure was removed from the abdominal cavity.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 35.8 kg/sqm.Pregnancy test urine - on (b)(6)2010: positive on (b)(6)2014, patient learned that she was pregnant.(b)(6)2014, us pelvis transabdominal and transvaginal: the endometrial cavity is distended with heterogeneous, mixed hypo-and hyperechoic material present.Differential considerations include retained products of conception and/or endometrial blood.Had leep 2000 states her pap always abnormal.Assessment and plan: pap smear with low grade squamous intraepithelial lesion.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6)2018: quality-safety evaluation of 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.

• 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: 7623954
• MDR Text Key: 111835565
• Report Number: 2951250-2018-02713
• 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: health professional,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2012
• Device Model Number: ESS305
• Device Lot Number: 699884
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 101