| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Migration (4003)
|
| Patient Problems
Abortion (1688); Coagulation Disorder (1779); Cyst(s) (1800); Diarrhea (1811); Edema (1820); Erythema (1840); Hair Loss (1877); Headache (1880); High Blood Pressure/ Hypertension (1908); Irritation (1941); Pain (1994); Uterine Perforation (2121); Visual Disturbances (2140); Burning Sensation (2146); Discomfort (2330); Weight Changes (2607); Heavier Menses (2666); Pregnancy (3193)
|
| Event Date 02/01/2014 |
|
Event Type
Injury
|
|
Event Description
|
|
This prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), pregnancy with contraceptive device ("hcp had reported a pregnancy with essure"), pre-eclampsia ("pre-eclampsia"), device dislocation ("no coils reported on path report"), von willebrand's disease ("von willebrand's disease") and genital haemorrhage ("heavy bleeding") in a (b)(6)-year-old female patient (gravida 7, para 5) who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" and device monitoring procedure not performed "no hsg done".The patient's past medical history included atrial septal defect, atrial septal defect repair in 2010, multigravida, parity 4, spontaneous abortion and postpartum state.Concurrent conditions included overweight.Concomitant products included fentanyl, ketorolac tromethamine (toradol), mepivacaine hydrochloride (carbocaine), midazolam hydrochloride (versed) and promethazine (phenergan).On (b)(6) 2013, the patient had essure inserted.In 2015, the patient experienced haemorrhage in pregnancy ("mild spotting during pregnancy after cervical exam").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant), pre-eclampsia (seriousness criterion medically significant) with headache, face oedema, visual impairment, ocular discomfort and oedema peripheral, vulvovaginal discomfort ("vaginal burning and irritation worse with urination"), device dislocation (seriousness criterion medically significant), vulvovaginal burning sensation ("vaginal burning worse with urination"), abdominal discomfort ("upset stomach"), diarrhoea ("diarrhea"), erythema ("intermittent reddening of skin"), von willebrand's disease (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), cyst ("cysts,"), alopecia ("alopecia"), coagulopathy ("blood clotting") and headache ("headaches,").The patient's last menstrual period was on (b)(6) 2014 and estimated date of delivery was (b)(6) 2015.The patient had essure during the first, second and third trimesters of pregnancy.The patient was treated with surgery (surgical removal of the essure device).Essure was removed on (b)(6) 2017.On (b)(6) 2015, the pregnancy with contraceptive device had resolved.At the time of the report, the pelvic pain, haemorrhage in pregnancy, pre-eclampsia, vulvovaginal discomfort, device dislocation, vulvovaginal burning sensation, abdominal discomfort, diarrhoea, erythema, von willebrand's disease, genital haemorrhage, cyst, alopecia, coagulopathy and headache outcome was unknown.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2015.(b)(6) g was the reported birth weight.The reporter considered alopecia, coagulopathy, cyst, genital haemorrhage, headache and pelvic pain to be related to essure.The reporter provided no causality assessment for abdominal discomfort, device dislocation, diarrhoea, erythema, haemorrhage in pregnancy, pre-eclampsia, pregnancy with contraceptive device, von willebrand's disease, vulvovaginal burning sensation and vulvovaginal discomfort with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6) kg/sqm.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a lack of efficacy.A contraceptive failure may occur under the use of any contraceptive and is not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither a batch number nor complaint sample were provided for a technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Most recent follow-up information incorporated above includes: on (b)(6) 2017: f/u summons-events heavy bleeding, pain, cysts, alopecia, and blood clotting added and essure was removed on (b)(6) 2017, case classification updated with potential legal case.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 pelvic pain ("pain"), pregnancy with contraceptive device ("hcp had reported a pregnancy with essure"), uterine perforation ("perforation uterus / no coils reported on path report/migration of essure device location of device: uterus"), embedded device ("second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium"), pre-eclampsia ("pre-eclampsia"), von willebrand's disease ("von willebrand's disease") and genital haemorrhage ("heavy bleeding") in a 34-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" and device monitoring procedure not performed "no hsg done".The patient's medical history included atrial septal defect, atrial septal defect repair in 2010, multigravida, parity 4, spontaneous abortion (2), postpartum state, preterm labour (vision impairment), multigravida and parity 5 (b)(6)2001, (b)(6)2003, (b)(6)2007, (b)(6)2013, (b)(6)2015).Previously administered products included for birth control: mirena.Concurrent conditions included overweight, kidney stone and sinus disorder.Concomitant products included fentanyl, ibuprofen, ketorolac tromethamine (toradol), medroxyprogesterone acetate (provera), mepivacaine hydrochloride (carbocaine), midazolam hydrochloride (versed), promethazine and thyroid (armour thyroid).On (b)(6)2013, the patient had essure inserted.In (b)(6) 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea (cramping)") and dyspareunia ("dyspareunia(painful sexual intercourse)").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), thyroid disorder ("thyroid disorders"), fatigue ("fatigue") and alopecia ("hair loss").In (b)(6) 2014, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2014, the patient experienced migraine ("migraines").In 2015, the patient experienced haemorrhage in pregnancy ("mild spotting during pregnancy after cervical exam").On (b)(6) 2017, the patient experienced endometriosis ("endometriosis") and adnexa uteri cyst ("paratubal cyst"), 3 years 5 months after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), pre-eclampsia (seriousness criterion medically significant) with headache, face oedema, visual impairment, ocular discomfort and oedema peripheral, vulvovaginal discomfort ("vaginal burning and irritation worse with urination"), vulvovaginal burning sensation ("vaginal burning worse with urination"), abdominal discomfort ("upset stomach"), diarrhoea ("diarrhea"), erythema ("intermittent reddening of skin"), von willebrand's disease (seriousness criterion medically significant), coagulopathy ("blood clotting"), menorrhagia ("abnormal bleeding (menorrhagia),"), vaginal haemorrhage ("abnormal bleeding vaginal"), abdominal pain lower ("pain in lower abdomen") and arthralgia ("hip pain").The patient was treated with surgery (hysterectomy with bilateral salpingectomy and supracervical hysterectomy (uterus only), surgical removal of coils).Essure was removed on (b)(6) 2017.On (b)(6) 2015, the pregnancy with contraceptive device had resolved.At the time of the report, the pelvic pain, genital haemorrhage, menorrhagia, vaginal haemorrhage, migraine, dysmenorrhoea, dyspareunia, fatigue, alopecia, abdominal pain lower and arthralgia had resolved and the haemorrhage in pregnancy, uterine perforation, embedded device, pre-eclampsia, vulvovaginal discomfort, vulvovaginal burning sensation, abdominal discomfort, diarrhoea, erythema, von willebrand's disease, coagulopathy, thyroid disorder, endometriosis and adnexa uteri cyst outcome was unknown.Pregnancy related information: prospective report.The patient's obstetric status was gravida 7, para 5.Last menstrual period was on (b)(6) 2014 and estimated date of delivery was (b)(6) 2015.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2015.2790g was the reported birth weight.The apgar scores were 8 and 9 (at 1 and 5 minutes).The reporter provided no causality assessment for abdominal discomfort, diarrhoea, erythema, haemorrhage in pregnancy, pre-eclampsia, pregnancy with contraceptive device, von willebrand's disease, vulvovaginal burning sensation and vulvovaginal discomfort with essure.The reporter considered abdominal pain lower, adnexa uteri cyst, alopecia, arthralgia, coagulopathy, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, genital haemorrhage, menorrhagia, migraine, pelvic pain, thyroid disorder, uterine perforation and vaginal haemorrhage to be related to essure.The reporter commented: from mr: the left essure coil is seen in the uterine corpus, near the left cornu, but is deeply embedded within the myometrial region.Identification of this device is made, but not without damage to the coil itself, with it being embedded into the corpus uteri.A second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium.Current weight 140 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.1 kg/sqm.Computerised tomogram - in (b)(6) 2014: results: coils were confirmed essure placed in tube.Pregnancy test - on (b)(6) 2014: results: positive.Ultrasound scan - on (b)(6) 2014: results: 6 weeks and 4 days.On (b)(6) 2017 final diagnosis findings revealed, the presence of the left essure coil is sought out and identified.This left essure coil is seen in the uterine corpus, near the left cornu, but is deeply embedded within the myometrial region.Identification of this device is made, but not without damage to the coil itself, with it being embedded into the corpus uteri.A second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: uterine perforation, embedded device, adnexa uteri cyst, pelvic pain, menorrhagia, endometriosis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received.Event outcome updated.Concomitant & historical conditions, drugs lab data were updated.Incident: no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances 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 pelvic pain ("pain"), pregnancy with contraceptive device ("hcp had reported a pregnancy with essure/pregnancy (withcomplications) vision impairment with last child resulting in preterm birth of baby."), haemorrhage in pregnancy ("mild spotting during pregnancy after cervical exam"), uterine perforation ("perforation uterus / no coils reported on path report/migration of essure device location of device: uterus"), embedded device ("second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium"), pre-eclampsia ("pre-eclampsia"), von willebrand's disease ("von willebrand's disease") and genital haemorrhage ("heavy bleeding/abnormal bleeding (general)") in a 34-year-old female patient who had essure (batch no.B53551) 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" and device monitoring procedure not performed "no hsg done".The patient's medical history included atrial septal defect, atrial septal defect repair in 2010, multigravida, parity 4, spontaneous abortion (2), postpartum state, preterm labour (vision impairment), multigravida and parity 5 ((b)(6) 2001, (b)(6) 2003, (b)(6) 2007, (b)(6) 2013, (b)(6) 2015)).*on (b)(6) 2017 final diagnosis findings revealed, the presence of the left essure coil is sought out and identified.This left essure coil is seen in the uterine corpus, near the left cornu, but is deeply embedded within the myometrial region.Identification of this device is made, but not without damage to the coil itself, with it being embedded into the corpus uteri.A second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium.Previously administered products included for birth control: mirena; for an unreported indication: prilosec.Concurrent conditions included overweight, kidney stone, sinus disorder and thyroid disorder.Concomitant products included estradiol (estrogen) for genital bleeding and menstrual cramps as well as fentanyl, ibuprofen, ketorolac tromethamine (toradol), medroxyprogesterone acetate (provera), mepivacaine hydrochloride (carbocaine), midazolam hydrochloride (versed), promethazine and thyroid (armour thyroid).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea (cramping)") and dyspareunia ("dyspareunia(painful sexual intercourse)").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), thyroid disorder ("thyroid disorders"), fatigue ("fatigue") and alopecia ("hair loss").In (b)(6) 2014, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2014, the patient experienced migraine ("migraines").In 2015, the patient experienced haemorrhage in pregnancy (seriousness criterion medically significant).On (b)(6) 2017, the patient experienced endometriosis ("endometriosis/other injury (ies) or complication please describe: endometriosis") and adnexa uteri cyst ("paratubal cyst"), 3 years 5 months after insertion of essure.On (b)(6) 2017, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), pre-eclampsia (seriousness criterion medically significant) with headache, face oedema, visual impairment, ocular discomfort and oedema peripheral, vulvovaginal discomfort ("vaginal burning and irritation worse with urination"), vulvovaginal burning sensation ("vaginal burning worse with urination"), abdominal discomfort ("upset stomach"), diarrhoea ("diarrhea"), erythema ("intermittant reddening of skin"), von willebrand's disease (seriousness criterion medically significant), coagulopathy ("blood clotting"), menorrhagia ("abnormal bleeding (menorrhagia),"), vaginal haemorrhage ("abnormal bleeding vaginal"), abdominal pain lower ("pain in lower abdomen") and arthralgia ("hip pain").The patient was treated with surgery (hysterectomy with bilateral salpingectomy and supracervical hysterectomy (uterus only), surgical removal of coils).Essure was removed on (b)(6) 2017.On (b)(6) 2015, the pregnancy with contraceptive device had resolved.At the time of the report, the pelvic pain, genital haemorrhage, menorrhagia, vaginal haemorrhage, migraine, dysmenorrhoea, dyspareunia, fatigue, alopecia, abdominal pain lower and arthralgia had resolved and the haemorrhage in pregnancy, uterine perforation, embedded device, pre-eclampsia, vulvovaginal discomfort, vulvovaginal burning sensation, abdominal discomfort, diarrhoea, erythema, von willebrand's disease, coagulopathy, thyroid disorder, endometriosis and adnexa uteri cyst outcome was unknown.Pregnancy related information: prospective report.The patient's obstetric status was gravida 7, para 5.Last menstrual period was on (b)(6) 2014 and estimated date of delivery was (b)(6) 2015.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2015.2790g was the reported birth weight.The apgar scores were 8 and 9 (at 1 and 5 minutes).The reporter provided no causality assessment for abdominal discomfort, diarrhoea, erythema, haemorrhage in pregnancy, pre-eclampsia, pregnancy with contraceptive device, von willebrand's disease, vulvovaginal burning sensation and vulvovaginal discomfort with essure.The reporter considered abdominal pain lower, adnexa uteri cyst, alopecia, arthralgia, coagulopathy, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, genital haemorrhage, menorrhagia, migraine, pelvic pain, thyroid disorder, uterine perforation and vaginal haemorrhage to be related to essure.The reporter commented: from mr: the left essure coil is seen in the uterine corpus, near the left cornu, but is deeply embedded within the myometrial region.Identification of this device is made, but not without damage to the coil itself, with it being embedded into the corpus uteri.A second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium.Current weight 140 lbs.On (b)(6) 2014- pregnancy (with complications) vision impairment with last child resulting in preterm birth of baby.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.1 kg/sqm.Computerised tomogram - in (b)(6) 2014: results: coils were confirmed essure placed in tube.Pregnancy test - on (b)(6) 2014: results: positive.Ultrasound scan - on (b)(6) 2014: results: 6 weeks and 4 days.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: uterine perforation, embedded device, adnexa uteri cyst, pelvic pain, menorrhagia and endometriosis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-mar-2019: quality safety evaluation of ptc.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.
|
| |
|
Manufacturer Narrative
|
|
This prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), pregnancy with contraceptive device ("hcp had reported a pregnancy with essure"), uterine perforation ("perforation uterus / no coils reported on path report/migration of essure device location of device: uterus"), embedded device ("second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium"), pre-eclampsia ("pre-eclampsia"), von willebrand's disease ("von willebrand's disease") and genital haemorrhage ("heavy bleeding") in a 34-year-old female patient (gravida 7, para 5) 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" and device monitoring procedure not performed "no hsg done".The patient's past medical history included atrial septal defect, atrial septal defect repair in 2010, multigravida, parity 4, spontaneous abortion (2), postpartum state and preterm labour.Previously administered products included for birth control: mirena.Concurrent conditions included overweight, kidney stone and sinus disorder.Concomitant products included fentanyl, ibuprofen (advil), ketorolac tromethamine (toradol), medroxyprogesterone acetate (provera), mepivacaine hydrochloride (carbocaine), midazolam hydrochloride (versed), promethazine (phenergan) and thyroid (armour thyroid).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea (cramping)") and dyspareunia ("dyspareunia(painful sexual intercourse),").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), thyroid disorder ("thyroid disorders"), fatigue ("fatigue") and alopecia ("hair loss").In (b)(6) 2014, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2014, the patient experienced migraine ("migraines").In 2015, the patient experienced haemorrhage in pregnancy ("mild spotting during pregnancy after cervical exam").On (b)(6) 2017, 3 years 5 months after insertion of essure, the patient experienced endometriosis ("endometriosis") and adnexa uteri cyst ("paratubal cyst").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), pre-eclampsia (seriousness criterion medically significant) with headache, face oedema, visual impairment, ocular discomfort and oedema peripheral, vulvovaginal discomfort ("vaginal burning and irritation worse with urination"), vulvovaginal burning sensation ("vaginal burning worse with urination"), abdominal discomfort ("upset stomach"), diarrhoea ("diarrhea"), erythema ("intermittant reddening of skin"), von willebrand's disease (seriousness criterion medically significant), coagulopathy ("blood clotting"), menorrhagia ("abnormal bleeding (menorrhagia),"), vaginal haemorrhage ("abnormal bleeding vaginal"), abdominal pain lower ("pain in lower abdomen") and arthralgia ("hip pain").The patient's last menstrual period was on (b)(6) 2014 and estimated date of delivery was (b)(6) 2015.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (surgical removal of the essure device) and surgery (supracervical hysterectomy (uterus only), surgical removal of coils).Essure was removed on (b)(6) 2017.On (b)(6) 2015, the pregnancy with contraceptive device had resolved.At the time of the report, the pelvic pain, genital haemorrhage, menorrhagia, vaginal haemorrhage, migraine, dysmenorrhoea, dyspareunia, fatigue and alopecia had resolved and the haemorrhage in pregnancy, uterine perforation, embedded device, pre-eclampsia, vulvovaginal discomfort, vulvovaginal burning sensation, abdominal discomfort, diarrhoea, erythema, von willebrand's disease, coagulopathy, thyroid disorder, endometriosis, adnexa uteri cyst, abdominal pain lower and arthralgia outcome was unknown.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2015.2790g was the reported birth weight.The apgar scores were 8 and 9 (at 1 and 5 minutes).The reporter provided no causality assessment for abdominal discomfort, diarrhoea, erythema, haemorrhage in pregnancy, pre-eclampsia, pregnancy with contraceptive device, von willebrand's disease, vulvovaginal burning sensation and vulvovaginal discomfort with essure.The reporter considered abdominal pain lower, adnexa uteri cyst, alopecia, arthralgia, coagulopathy, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, genital haemorrhage, menorrhagia, migraine, pelvic pain, thyroid disorder, uterine perforation and vaginal haemorrhage to be related to essure.The reporter commented: from mr: the left essure coil is seen in the uterine corpus, near the left cornu, but is deeply embedded within the myometrial region.Identification of this device is made, but not without damage to the coil itself, with it being embedded into the corpus uteri.A second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium.Current weight 140 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.1 kg/sqm.Computerised tomogram - in (b)(6) 2014: coils were confirmed essure placed in tube pregnancy test - on (b)(6) 2014: positive.Ultrasound scan - on (b)(6) 2014: 6 weeks and 4 days.On (b)(6) 2017 final diagnosis findings revealed, the presence of the left essure coil is sought out and identified.This left essure coil is seen in the uterine corpus, near the left cornu, but is deeply embedded within the myometrial region.Identification of this device is made, but not without damage to the coil itself, with it being embedded into the corpus uteri.A second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: uterine perforation, embedded device, adnexa uteri cyst, pelvic pain, menorrhagia, endometriosis.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 11-jun-2018: pfs and mr received.Events added per pfs: abnormal bleeding (vaginal, menorrhagia), thyroid disorders, migraines, paratubal cyst (updated previous event "cyst"), endometriosis, fatigue, dyspareunia, dysmenorrhea, pain in lower abdomen, hip pain, perforation of uterus / device migration to uterus.Event added per mr: embedded device.Lab data , concomitant disease, concomitants drugs, historical conditions were added.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 pelvic pain ("pain"), pregnancy with contraceptive device ("hcp had reported a pregnancy with essure/pregnancy (with complications) vision impairment with last child resulting in preterm birth of baby."), uterine perforation ("perforation uterus / no coils reported on path report/migration of essure device location of device: uterus"), embedded device ("second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium"), pre-eclampsia ("pre-eclampsia"), von willebrand's disease ("von willebrand's disease") and genital haemorrhage ("heavy bleeding/abnormal bleeding (general)") in a 34-year-old female patient who had essure (batch no.B53551) 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" and device monitoring procedure not performed "no hsg done".The patient's medical history included atrial septal defect, atrial septal defect repair in 2010, multigravida, parity 4, spontaneous abortion (2), postpartum state, preterm labour (vision impairment), multigravida and parity 5 (b)(6)2001, (b)(6)2003, (b)(6)2007, (b)(6)2013, (b)(6)2015)).*on (b)(6)2017 final diagnosis findings revealed, the presence of the left essure coil is sought out and identified.This left essure coil is seen in the uterine corpus, near the left cornu, but is deeply embedded within the myometrial region.Identification of this device is made, but not without damage to the coil itself, with it being embedded into the corpus uteri.A second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium.Previously administered products included for birth control: mirena; for an unreported indication: prilosec.Concurrent conditions included overweight, kidney stone, sinus disorder and thyroid disorder.Concomitant products included estradiol (estrogen) for genital bleeding and menstrual cramps as well as fentanyl, ibuprofen, ketorolac tromethamine (toradol), medroxyprogesterone acetate (provera), mepivacaine hydrochloride (carbocaine), midazolam hydrochloride (versed), promethazine and thyroid (armour thyroid).On (b)(6)2013, the patient had essure inserted.In (b)(6)2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea (cramping)") and dyspareunia ("dyspareunia(painful sexual intercourse)").In (b)(6)2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), thyroid disorder ("thyroid disorders"), fatigue ("fatigue") and alopecia ("hair loss").In (b)(6)2014, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6)2014, the patient experienced migraine ("migraines").In 2015, the patient experienced haemorrhage in pregnancy ("mild spotting during pregnancy after cervical exam").On (b)(6)2017, the patient experienced endometriosis ("endometriosis/other injury (ies) or complication please describe: endometriosis") and adnexa uteri cyst ("paratubal cyst"), 3 years 5 months after insertion of essure.On (b)(6)2017, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), pre-eclampsia (seriousness criterion medically significant) with headache, face oedema, visual impairment, ocular discomfort and oedema peripheral, vulvovaginal discomfort ("vaginal burning and irritation worse with urination"), vulvovaginal burning sensation ("vaginal burning worse with urination"), abdominal discomfort ("upset stomach"), diarrhoea ("diarrhea"), erythema ("intermittent reddening of skin"), von willebrand's disease (seriousness criterion medically significant), coagulopathy ("blood clotting"), menorrhagia ("abnormal bleeding (menorrhagia),"), vaginal haemorrhage ("abnormal bleeding vaginal"), abdominal pain lower ("pain in lower abdomen") and arthralgia ("hip pain").The patient was treated with surgery (hysterectomy with bilateral salpingectomy and supracervical hysterectomy (uterus only), surgical removal of coils).Essure was removed on (b)(6)2017.On (b)(6)2015, the pregnancy with contraceptive device had resolved.At the time of the report, the pelvic pain, genital haemorrhage, menorrhagia, vaginal haemorrhage, migraine, dysmenorrhoea, dyspareunia, fatigue, alopecia, abdominal pain lower and arthralgia had resolved and the haemorrhage in pregnancy, uterine perforation, embedded device, pre-eclampsia, vulvovaginal discomfort, vulvovaginal burning sensation, abdominal discomfort, diarrhoea, erythema, von willebrand's disease, coagulopathy, thyroid disorder, endometriosis and adnexa uteri cyst outcome was unknown.Pregnancy related information: prospective report.The patient's obstetric status was gravida 7, para 5.Last menstrual period was on (b)(6)2014 and estimated date of delivery was (b)(6)2015.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6)2015.2790g was the reported birth weight.The apgar scores were 8 and 9 (at 1 and 5 minutes).The reporter provided no causality assessment for abdominal discomfort, diarrhoea, erythema, haemorrhage in pregnancy, pre-eclampsia, pregnancy with contraceptive device, von willebrand's disease, vulvovaginal burning sensation and vulvovaginal discomfort with essure.The reporter considered abdominal pain lower, adnexa uteri cyst, alopecia, arthralgia, coagulopathy, dysmenorrhoea, dyspareunia, embedded device, endometriosis, fatigue, genital haemorrhage, menorrhagia, migraine, pelvic pain, thyroid disorder, uterine perforation and vaginal haemorrhage to be related to essure.The reporter commented: from mr: the left essure coil is seen in the uterine corpus, near the left cornu, but is deeply embedded within the myometrial region.Identification of this device is made, but not without damage to the coil itself, with it being embedded into the corpus uteri.A second essure coil is also identified in the area of the right cornu.This coil is also seen extending into the myometrium.Current weight 140 lbs.On (b)(6)2014- pregnancy (with complications) vision impairment with last child resulting in preterm birth of baby.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.1 kg/sqm.Computerised tomogram - in (b)(6)2014: results: coils were confirmed essure placed in tube.Pregnancy test - on (b)(6)2014: results: positive.Ultrasound scan - on (b)(6)2014: results: 6 weeks and 4 days.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: uterine perforation, embedded device, adnexa uteri cyst, pelvic pain, menorrhagia and endometriosis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-mar-2019: pfs received- lot number was added.Severity of pelvic pain was added.Onset date of uterine perforation was added.Concomitant medication and medical history was added.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.
|
| |
|
Search Alerts/Recalls
|
|
