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

BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Device Inoperable (1663); Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hair Loss (1877); Unspecified Infection (1930); Menstrual Irregularities (1959); Miscarriage (1962); Nausea (1970); Pain (1994); Pelvic Inflammatory Disease (2000); Rash (2033); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Anxiety (2328); Depression (2361); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193)

Event Date 06/01/2016

Event Type Injury

Event Description

Manufacturer Narrative

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of uterine perforation ("perforation (uterus)/ migration of essure device/ malposition of essure device location of device: right side and in uterus/migration of essure device location of device: uterus and fallopian tube/failure to occlude (close) fallopian tube(s),"), fallopian tube perforation ("perforation (fallopian tube(s))"), device breakage ("device breakage"), pregnancy with contraceptive device ("pregnancy (stillbirth or miscarriage)") and stillbirth ("stillbirth") in a 31-year-old female patient (gravida 4, para 3) who had essure (batch no.863576) 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 abdominal pain on (b)(6) 2011, gravida and parity 3 (((b)(6) 2004, (b)(6) 2008, (b)(6) 2011)).Concurrent conditions included body mass index normal, diabetes mellitus gestational, herpes nos, chlamydial infection since (b)(6) 2016, herpes nos since (b)(6) 2016, sexually transmitted disease since (b)(6) 2015, alcohol use and bacterial vaginosis.Concomitant products included cilest (sprintec) for birth control.On (b)(6) 2011, the patient had essure inserted.In 2013, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/cramps felt like labour pain") and alopecia ("hair loss").In 2014, the patient experienced vaginal infection ("infection (bladder/ urinary tract/vaginal) type: vaginal infections") with vaginal discharge and fungal infection ("infection(bladder/urinary tract/vaginal)-type: yeast infection").On (b)(6) 2015, 3 years 8 months after insertion of essure, the patient experienced device expulsion ("expulsion of essure device.").In 2015, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal pain lower ("abdominal pain below").In 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)/excessive bleeding, long lasting and with clots") and stillbirth (seriousness criterion medically significant).In (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain.In (b)(6) 2016, the patient experienced weight increased ("weight gain/15-20 lbs").On (b)(6) 2016, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), anxiety ("anxiety"), depression ("depression"), rash ("rashes or skin conditions type: rash/rash and hives in face sporadically/ rashes on face"), fatigue ("fatigue/weak and tired, drained for no reason."), coital bleeding ("bleeding after intercourse"), nausea ("nausea/after intercourse i would get nauseated"), back pain ("lower back pain/excessive back pain"), mood swings ("mood swings/ hormal changes-describe: mood swings"), hot flush ("hot flashes"), night sweats ("night sweats"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), vision blurred ("blurry visions"), urinary tract infection ("urinary tract infection") and asthenia ("weak").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first, second and third trimesters of pregnancy.The patient was treated with bactrim (mortin), tramadol, roxithromycin (riboxin), aciclovir (acyclovir [aciclovir]), surgery (surgical removal of coil(s))/hysteroscopy, d and c, removal of right essure and diagnostic laparosc).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, fallopian tube perforation, pregnancy with contraceptive device, mood swings, hot flush, night sweats, female sexual dysfunction, vision blurred, fungal infection, abdominal pain lower, urinary tract infection, stillbirth and asthenia had resolved, the device breakage, vaginal haemorrhage, menorrhagia, vaginal infection, anxiety, depression, rash, dysmenorrhoea, dyspareunia, fatigue, weight increased, coital bleeding, alopecia, nausea and back pain had not resolved and the device expulsion outcome was unknown.The pregnancy outcome was reported as stillbirth.The reporter considered abdominal pain lower, alopecia, anxiety, asthenia, back pain, coital bleeding, depression, device breakage, device expulsion, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, female sexual dysfunction, fungal infection, hot flush, menorrhagia, mood swings, nausea, night sweats, pregnancy with contraceptive device, rash, stillbirth, urinary tract infection, uterine perforation, vaginal haemorrhage, vaginal infection, vision blurred and weight increased to be related to essure.The reporter commented: coils: right tube: 3 left tube: 5.The patient tolerated the procedure well.On (b)(6) 2016: 1.One essure micro·insert is present within the endometrial cavity.It moved from the uterine fundus to the lower uterine segment during the exam.2.There is a solitary metallic band in close proximity to the cornu of the right uterus.This is suspected to originated from the micro-insert that is now within the endometrial cavity.3.The left fallopian tube essure micro-insert is absent.It is suspected to have been evacuated.It is not present within the abdomen or pelvis.Essure confirmation test :it showed a broken piece of essure from right floating in the endometrial cavity and a missing left essure.Right: essure seen in the lower uterine segment.The left essure was not visualized.Seen in her abdomen or pelvis elsewhere.She is also contemplating to get pregnant in the future perhaps.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2016: abnormally placed right essure.Current weight was 160 lbs.On an unknown date she had hysterosalpingogram which reveled that one of my coils had exited my body and the other coil had broken in half, the other piece of my coil was in my uterus.(b)(6) 2016 , (b)(6) 2016 :hysterosalpingogram (hsg) essure confirmation tests date : result: failure to occlude (close) fallopian tubes, malposition of essure device, migration of essure device, expulsion of essure device perforation (fallopian tube) and perforation (uterus) hysteroscopy, dilatation and curettage and removal of abdominally placed right essure, diagnostic laparoscopy, and chromopertubation.(b)(6) 2015 : sonogram : the sonogram was abnormal.The report reveals the presence of essure on right side appears malposltloned.(b)(6) 2016 : essure micro-insert placements check: one essure micro insert is present within the endometrial cavity.It moved from the uterine fundus to the lower uterine segment during the exam.There is a solitary metallic band in close proximity to the cornu of the right uterus.This is suspected to originate from the micro-insert that is now within the endometrial cavity and the left fallopian tube essure micro-insert is absent.It is suspected to have been evacuated.It is not present within the abdomen or pelvis.Laparoscopy : essure protruding through the fallopian tubes bilaterally.Both ovaries appeared to be normal on (b)(6) 2015: she states the isolated incident where she may have been exposed occurred 2 weeks ago.She also reports vaginal discharge that began 2 weeks ago.The discharge is described as thin and white colored.The patient admits to a history of condom broke with intercourse.Pt also reports painful cycles for years, getting worse.Treatment in the past has been muscle relaxers and narcotics.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical record: confirming - dysmenorrhea, menorrhagia, pelvic pain, bacterial vaginosis, back pain.And describing- vaginal discharge" most recent follow-up information incorporated above includes: on 1-jun-2018: plaintiff fact sheet and medical record received.Reporter information, patient¿s demographic information, other relevant history and lab data updated.Essure indication and removal date was added.Events: mood swings, hot flush, night sweats, female sexual dysfunction, vision blurred, fungal infection, abdominal pain lower, urinary tract infection, still birth were newly added.Pregnancy outcome updated to stillbirth from not reported.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 uterine perforation ("perforation (uterus)/ migration of essure device/ malposition of essure device location of device: right side and in uterus/migration of essure device location of device: uterus and fallopian tube/failure to occlude (close) fallopian tube(s),"), fallopian tube perforation ("perforation (fallopian tube(s))"), device breakage ("device breakage"), pregnancy with contraceptive device ("pregnancy (stillbirth or miscarriage)") and stillbirth ("stillbirth") in a 31-year-old female patient (gravida 4, para 3) who had essure (batch no.863576) 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 abdominal pain on (b)(6) 2011, multigravida and parity 3 (((b)(6) 2004, (b)(6) 2008, (b)(6) 2011)).Concurrent conditions included body mass index normal, diabetes mellitus gestational, herpes nos, chlamydial infection since (b)(6) 2016, herpes nos since (b)(6) 2016, sexually transmitted disease since (b)(6) 2015, alcohol use and bacterial vaginosis.Concomitant products included cilest (sprintec) for birth control.On (b)(6) 2011, the patient had essure inserted.In 2013, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/cramps felt like labour pain") and alopecia ("hair loss").In 2014, the patient experienced vaginal infection ("infection (bladder/ urinary tract/vaginal) type: vaginal infections") with vaginal discharge, urogenital infection fungal ("infection(bladder/urinary tract/vaginal)-type: yeast infection") and vulvovaginal mycotic infection ("yeast infection").On (b)(6) 2015, 3 years 8 months after insertion of essure, the patient experienced device expulsion ("expulsion of essure device.").In 2015, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal pain lower ("abdominal pain below").In 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)/excessive bleeding, long lasting and with clots") and stillbirth (seriousness criterion medically significant).In (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain.In (b)(6) 2016, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and weight increased ("weight gain/15-20 lbs").On (b)(6) 2016, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced anxiety ("anxiety"), depression ("depression"), rash ("rashes or skin conditions type: rash/rash and hives in face sporadically/ rashes on face"), fatigue ("fatigue/weak and tired, drained for no reason."), coital bleeding ("bleeding after intercourse"), nausea ("nausea/after intercourse i would get nauseated"), back pain ("lower back pain/excessive back pain"), mood swings ("mood swings/ normal changes-describe: mood swings"), hot flush ("hot flashes"), night sweats ("night sweats"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), vision blurred ("blurry visions"), urinary tract infection ("urinary tract infection") and asthenia ("weak").Last menstrual period and estimated date of delivery were not provided.The patient was treated with bactrim (mortin), tramadol, roxithromycin (riboxin), aciclovir (acyclovir [aciclovir]), surgery (hysteroscopy, d and c, removal of right essure and diagnostic laparoscopy and chromopertubation), surgery (hysteroscopy, d and c, removal of right essure and diagnostic laparoscopy and chromopertubation) and surgery (hysteroscopy, d and c, removal of right essure and diagnostic laparoscopy and chromopertubation).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, fallopian tube perforation, pregnancy with contraceptive device, mood swings, hot flush, night sweats, female sexual dysfunction, vision blurred, urogenital infection fungal, abdominal pain lower, urinary tract infection, stillbirth, asthenia and vulvovaginal mycotic infection had resolved, the device breakage, vaginal haemorrhage, menorrhagia, vaginal infection, anxiety, depression, rash, dysmenorrhoea, dyspareunia, fatigue, weight increased, coital bleeding, alopecia, nausea and back pain had not resolved and the device expulsion outcome was unknown.The pregnancy outcome was reported as stillbirth.The reporter considered abdominal pain lower, alopecia, anxiety, asthenia, back pain, coital bleeding, depression, device breakage, device expulsion, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, female sexual dysfunction, hot flush, menorrhagia, mood swings, nausea, night sweats, pregnancy with contraceptive device, rash, stillbirth, urinary tract infection, urogenital infection fungal, uterine perforation, vaginal haemorrhage, vaginal infection, vision blurred, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: coils: right tube: 3 left tube: 5.The patient tolerated the procedure well.On (b)(6) 2016: 1.One essure micro·insert is present within the endometrial cavity.It moved from the uterine fundus to the lower uterine segment during the exam.2.There is a solitary metallic band in close proximity to the cornu of the right uterus.This is suspected to originated from the micro-insert that is now within the endometrial cavity.3.The left fallopian tube essure micro-insert is absent.It is suspected to have been evacuated.It is not present within the abdomen or pelvis.Essure confirmation test :it showed a broken piece of essure from right floating in the endometrial cavity and a missing left essure.Right:l essure seen in the lower uterine segment.The left essure was not visualized.Seen in her abdomen or pelvis elsewhere.She is also contemplating to get pregnant in the future perhaps.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2016: abnormally placed right essure.Current weight was 160 lbs.On an unknown date she had hysterosalpingogram which reveled that one of my coils had exited my body and the other coil had broken in half, the other piece of my coil was in my uterus.(b)(6) 2016 :hysterosalpingogram (hsg) essure confirmation tests date : result: failure to occlude (close) fallopian tubes, malposition of essure device, migration of essure device, expulsion of essure device perforation (fallopian tube) and perforation (uterus) hysteroscopy, dilatation and curettage and removal of abdominally placed right essure, diagnostic laparoscopy, and chromopertubation.(b)(6) 2015 : sonogram : the sonogram was abnormal.The report reveals the presence of essure on right side appears malposltloned.(b)(6) 2016 : essure micro-insert placements check: one essure micro insert is present within the endometrial cavity.It moved from the uterine fundus to the lower uterine segment during the exam.There is a solitary metallic band in close proximity to the cornu of the right uterus.This is suspected to originate from the micro-insert that is now within the endometrial cavity and the left fallopian tube essure micro-insert is absent.It is suspected to have been evacuated.It is not present within the abdomen or pelvis.Laparoscopy : essure protruding through the fallopian tubes bilaterally.Both ovaries appeared to be normal on (b)(6) 2015: she states the isolated incident where she may have been exposed occurred 2 weeks ago.She also reports vaginal discharge that began 2 weeks ago.The discharge is described as thin and white colored.The patient admits to a history of condom broke with intercourse.Pt also reports painful cycles for years, getting worse.Treatment in the past has been muscle relaxers and narcotics.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical record: confirming - dysmenorrhea, menorrhagia, pelvic pain, bacterial vaginosis, back pain.And describing- vaginal discharge" quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-sep-2018: pfs received.Event yeast infection 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

Rospective pregnancy case was reported by a lawyer and describes the occurrence of uterine perforation ("perforation (uterus)/ migration of essure device/ malposition of essure device location of device: right side and in uterus/migration of essure device location of device: uterus and fallopian tube/failure to occlude (close) fallopian tube(s),"), fallopian tube perforation ("perforation (fallopian tube(s))"), device breakage ("device breakage"), pregnancy with contraceptive device ("pregnancy (stillbirth or miscarriage)") and stillbirth ("stillbirth") in a 31-year-old female patient (gravida 4, para 3) who had essure (batch no.863576) 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 abdominal pain on 10-jan-2011, multigravida and parity 3 ((21jun2004, 10aug2008, 14jul2011)).Concurrent conditions included body mass index normal, diabetes mellitus gestational, herpes nos, chlamydial infection since (b)(6).2016, herpes nos since 20-jul-2016, sexually transmitted disease since (b)(6).2015, alcohol use and bacterial vaginosis.Concomitant products included cilest (sprintec) for birth control.On (b)(6).2011, the patient had essure inserted.In 2013, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/cramps felt like labour pain") and alopecia ("hair loss").In 2014, the patient experienced vaginal infection ("infection (bladder/ urinary tract/vaginal) type: vaginal infections") with vaginal discharge and urogenital infection fungal ("infection(bladder/urinary tract/vaginal)-type: yeast infection").On 24-apr-2015, 3 years 8 months after insertion of essure, the patient experienced device expulsion ("expulsion of essure device.").In 2015, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal pain lower ("abdominal pain below").In 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)/excessive bleeding, long lasting and with clots") and stillbirth (seriousness criterion medically significant).In june 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On 20-jul-2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain.In november 2016, the patient experienced weight increased ("weight gain/15-20 lbs").On (b)(6).2016, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), anxiety ("anxiety"), depression ("depression"), rash ("rashes or skin conditions type: rash/rash and hives in face sporadically/ rashes on face"), fatigue ("fatigue/weak and tired, drained for no reason."), coital bleeding ("bleeding after intercourse"), nausea ("nausea/after intercourse i would get nauseated"), back pain ("lower back pain/excessive back pain"), mood swings ("mood swings/ hormal changes-describe: mood swings"), hot flush ("hot flashes"), night sweats ("night sweats"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), vision blurred ("blurry visions"), urinary tract infection ("urinary tract infection") and asthenia ("weak").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 bactrim (mortin), tramadol, roxithromycin (riboxin), aciclovir (acyclovir [aciclovir]), surgery (surgical removal of coil(s))/hysteroscopy, d and c, removal of right essure and diagnostic laparosc), surgery (surgical removal of coils.)essure was removed on 20-jul-2016.At the time of the report, the uterine perforation, fallopian tube perforation, pregnancy with contraceptive device, mood swings, hot flush, night sweats, female sexual dysfunction, vision blurred, urogenital infection fungal, abdominal pain lower, urinary tract infection, stillbirth and asthenia had resolved, the device breakage, vaginal haemorrhage, menorrhagia, vaginal infection, anxiety, depression, rash, dysmenorrhoea, dyspareunia, fatigue, weight increased, coital bleeding, alopecia, nausea and back pain had not resolved and the device expulsion outcome was unknown.The pregnancy outcome was reported as stillbirth.The reporter considered abdominal pain lower, alopecia, anxiety, asthenia, back pain, coital bleeding, depression, device breakage, device expulsion, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, female sexual dysfunction, hot flush, menorrhagia, mood swings, nausea, night sweats, pregnancy with contraceptive device, rash, stillbirth, urinary tract infection, urogenital infection fungal, uterine perforation, vaginal haemorrhage, vaginal infection, vision blurred and weight increased to be related to essure.The reporter commented: coils: right tube: 3 left tube: 5 the patient tolerated the procedure well.On (b)(6).2016: 1.One essure micro·insert is present within the endometrial cavity.It moved from the uterine fundus to the lower uterine segment during the exam.2.There is a solitary metallic band in close proximity to the cornu of the right uterus.This is suspected to originated from the micro-insert that is now within the endometrial cavity.3.The left fallopian tube essure micro-insert is absent.It is suspected to have been evacuated.It is not present within the abdomen or pelvis.Essure confirmation test :it showed a broken piece of essure from right floating in the endometrial cavity and a missing left essure.Right essure seen in the lower uterine segment.The left essure was not visualized.Seen in her abdomen or pelvis elsewhere.She is also contemplating to get pregnant in the future perhaps.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.7 kg/sqm.Hysterosalpingogram - on 14-jul-2016: abnormally placed right essure current weight was 160 lbs.On an unknown date she had hysterosalpingogram which reveled that one of my coils had exited my body and the other coil had broken in half, the other piece of my coil was in my uterus.14jun2016 , 20jul2016 :hysterosalpingogram (hsg) essure confirmation tests date : result: failure to occlude (close) fallopian tubes, malposition of essure device, migration of essure device, expulsion of essure device perforation (fallopian tube) and perforation (uterus) hysteroscopy, dilatation and curettage and removal of abdominally placed right essure, diagnostic laparoscopy, and chromopertubation.4-may-2015 : sonogram : the sonogram was abnormal.The report reveals the presence of essure on right side appears malposltloned.14-jun-2016 : essure micro-insert placements check: one essure micro insert is present within the endometrial cavity.It moved from the uterine fundus to the lower uterine segment during the exam.There is a solitary metallic band in close proximity to the cornu of the right uterus.This is suspected to originate from the micro-insert that is now within the endometrial cavity and the left fallopian tube essure micro-insert is absent.It is suspected to have been evacuated.It is not present within the abdomen or pelvis.Laparoscopy : essure protruding through the fallopian tubes bilaterally.Both ovaries appeared to be normal on (b)(6).2015: she states the isolated incident where she may have been exposed occurred 2 weeks ago.She also reports vaginal discharge that began 2 weeks ago.The discharge is described as thin and whitecolored.The patient admits to a history of condom broke with intercourse.Pt also reports painful cycles for years, getting worse.Treatment in the past has been muscle relaxers and narcotics.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical record: confirming - dysmenorrhea, menorrhagia, pelvic pain, bacterial vaginosis, back pain.And describing- vaginal discharge" 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 ptc 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 uterine perforation ('perforation (uterus)/ migration of essure device/ malposition of essure device location of device: right side and in uterus/migration of essure device location of device: uterus and fallopian tube/failure to occlude (close) fallopian tube(s)'), fallopian tube perforation ('perforation (fallopian tube(s))'), device breakage ('device breakage/broken coil'), uterine infection ('coil puncture my uterus and cause infection'), stillbirth ('stillbirth') and pregnancy with contraceptive device ('pregnancy (stillbirth or miscarriage)') in a 31-year-old female patient who had essure (batch no.863576) 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 abdominal pain on(b)(6) 2011, multigravida and parity 3 (((b)(6) 2004, (b)(6) 2008, (b)(6) 2011)).Current weight was 160 lbs.On an unknown date she had hysterosalpingogram which reveled that one of my coils had exited my body and the other coil had broken in half, the other piece of my coil was in my uterus.(b)(6) 2016 , (b)(6) 2016 :hysterosalpingogram (hsg) essure confirmation tests date : result: failure to occlude (close) fallopian tubes, malposition of essure device, migration of essure device, expulsion of essure device perforation (fallopian tube) and perforation (uterus) hysteroscopy, dilatation and curettage and removal of abdominally placed right essure, diagnostic laparoscopy, and chromopertubation.On (b)(6) 2015 : sonogram : the sonogram was abnormal.The report reveals the presence of essure on right side appears malposltloned.On (b)(6) 2016 : essure micro-insert placements check: one essure micro insert is present within the endometrial cavity.It moved from the uterine fundus to the lower uterine segment during the exam.There is a solitary metallic band in close proximity to the cornu of the right uterus.This is suspected to originate from the micro-insert that is now within the endometrial cavity and the left fallopian tube essure micro-insert is absent.It is suspected to have been evacuated.It is not present within the abdomen or pelvis.Laparoscopy : essure protruding through the fallopian tubes bilaterally.Both ovaries appeared to be normal on (b)(6) 2015: she states the isolated incident where she may have been exposed occurred 2 weeks ago.She also reports vaginal discharge that began 2 weeks ago.The discharge is described as thin and white colored.The patient admits to a history of condom broke with intercourse.Pt also reports painful cycles for years, getting worse.Treatment in the past has been muscle relaxers and narcotics.Concurrent conditions included chlamydial infection since (b)(6) 2016, herpes nos since (b)(6) 2016, sexually transmitted disease since (b)(6) 2015, body mass index normal, diabetes mellitus gestational, herpes nos, alcohol use and bacterial vaginosis.Concomitant products included ethinylestradiol;norgestimate (sprintec) for birth control.On (b)(6) 2011, the patient had essure inserted.In 2013, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/cramps felt like labour pain") and alopecia ("hair loss").In 2014, the patient experienced vaginal infection ("infection (bladder/ urinary tract/vaginal) type: vaginal infections") with vaginal discharge, vulvovaginal mycotic infection ("infection(bladder/urinary tract/vaginal)-type: yeast infection") and fungal infection ("yeast infection").On (b)(6) 2015, the patient experienced device expulsion ("expulsion of essure device."), 3 years 8 months after insertion of essure.In 2015, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal pain lower ("abdominal pain below").In (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required).In 2016, the patient experienced stillbirth (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)/excessive bleeding, long lasting and with clots").On (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain.In (b)(6) 2016, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and was found to have weight increased ("weight gain/15-20 lbs").On (b)(6) 2016, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced uterine infection (seriousness criteria medically significant and intervention required), anxiety ("anxiety"), depression ("depression"), rash ("rashes or skin conditions type: rash/rash and hives in face sporadically/ rashes on face"), fatigue ("fatigue/weak and tired, drained for no reason."), coital bleeding ("bleeding after intercourse"), nausea ("nausea/after intercourse i would get nauseated"), back pain ("lower back pain/excessive back pain/chronic back pain"), mood swings ("mood swings/ hormonal changes-describe: mood swings"), hot flush ("hot flashes"), night sweats ("night sweats"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), vision blurred ("blurry visions"), urinary tract infection ("urinary tract infection"), asthenia ("weak") and abdominal pain upper ("stomach hurting every time she have to get up and go to the bathroom").The patient was treated with aciclovir (acyclovir), roxithromycin (riboxin), sulfamethoxazole;trimethoprim (mortin), tramadol and surgery (hysteroscopy, d and c, removal of right essure and diagnostic laparoscopy and chromopertubation).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, fallopian tube perforation, stillbirth, pregnancy with contraceptive device, mood swings, hot flush, night sweats, female sexual dysfunction, vision blurred, vulvovaginal mycotic infection, abdominal pain lower, urinary tract infection, asthenia and fungal infection had resolved, the device breakage, vaginal haemorrhage, menorrhagia, vaginal infection, anxiety, depression, rash, dysmenorrhoea, dyspareunia, fatigue, weight increased, coital bleeding, alopecia, nausea and back pain had not resolved and the uterine infection, device expulsion and abdominal pain upper outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 4, para 3.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 reported as stillbirth.The reporter considered abdominal pain lower, abdominal pain upper, alopecia, anxiety, asthenia, back pain, coital bleeding, depression, device breakage, device expulsion, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, female sexual dysfunction, fungal infection, hot flush, menorrhagia, mood swings, nausea, night sweats, pregnancy with contraceptive device, rash, stillbirth, urinary tract infection, uterine infection, uterine perforation, vaginal haemorrhage, vaginal infection, vision blurred, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: coils: right tube: 3 left tube: 5 the patient tolerated the procedure well.On (b)(6) 2016: 1.One essure micro·insert is present within the endometrial cavity.It moved from the uterine fundus to the lower uterine segment during the exam.2.There is a solitary metallic band in close proximity to the cornu of the right uterus.This is suspected to originated from the micro-insert that is now within the endometrial cavity.3.The left fallopian tube essure micro-insert is absent.It is suspected to have been evacuated.It is not present within the abdomen or pelvis.Essure confirmation test :it showed a broken piece of essure from right floating in the endometrial cavity and a missing left essure.Right essure seen in the lower uterine segment.The left essure was not visualized.Seen in her abdomen or pelvis elsewhere.She is also contemplating to get pregnant in the future perhaps.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2016: results: abnormally placed right essure.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical record: confirming - dysmenorrhea, menorrhagia, pelvic pain, bacterial vaginosis, back pain.And describing- vaginal discharge" concerning the injuries reported in this case, the following ones were reported via social medial: stomach hurting every time she have to get up and go to the bathroom.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2019: social media received.Reporter information added.Events: stomach hurting, uterine infection added.Event coding changed from urogenital infection to vulvovaginal mycotic infection.Incident: 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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

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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

7432067

MDR Text Key

105517607

Report Number

2951250-2018-01820

Device Sequence Number

Product Code

HHS

Combination Product (y/n)

PMA/PMN Number

P020014

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,health professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

04/16/2018

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Health Professional

Device Expiration Date

05/01/2014

Device Model Number

ESS305

Device Lot Number

863576

Was Device Available for Evaluation?

Was the Report Sent to FDA?

Date Manufacturer Received

12/02/2019

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Treatment

SPRINTEC; SPRINTEC; SPRINTEC; SPRINTEC; SPRINTEC; SPRINTEC

Patient Outcome(s)

Other; Required Intervention;

Patient Age

31 YR

Patient Weight

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

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