| Model Number ESS305 |
| Device Problems
Break (1069); Biocompatibility (2886); Material Integrity Problem (2978); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Abdominal Pain (1685); Uterine Perforation (2121); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 01/01/2016 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain lower ('chronic pain in the left iliac fossa'), device breakage ('device fragmented') and uterine perforation ('one of them poorly located / incorrect location / one of myometrial location with exit to the peroneum ') in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use issue "two inserts placed in one tube".The patient's medical history included pre-eclampsia in 2009, stillbirth nos in 2009, parity 2, kidney failure and female sterilisation.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), uterine perforation (seriousness criterion medically significant), discomfort ("persistent discomfort") and allergy to metals ("allergic to nickel").The patient was treated with surgery (left salpingectomy).At the time of the report, the abdominal pain lower, device breakage, uterine perforation, discomfort and allergy to metals outcome was unknown.The reporter considered abdominal pain lower, allergy to metals, device breakage, discomfort and uterine perforation to be related to essure.The reporter commented: during the pregnancy tests carried out in 2009, she was detected to have high blood pressure.On (b)(6) 2009, she went to the emergency room for severe abdominal pain and metrorrhagia, and after an ultrasound scan it was detected that the fetus was dead.Being pregnant again in 2010, in early (b)(6), and in view of the suspicion of iugr (intrauterine growth restriction) and peg (small baby for age) as well as oligohydramnios (decrease in amniotic fluid below the normal level for gestational age), it was decided to induce labor.After miscarriage in (b)(6) 2014, she become pregnant again in (b)(6) 2014.During the pregnancy controls carried out, she was diagnosed with kell antigen, so a caesarean section was scheduled for (b)(6) (week 37 of gestation).It was also decided to perform tubal ligation, the e right tube was tied, but the left tube cannot be tied because it had an important adhesion syndrome.On (b)(6) 2015, two essure devices were inserted into her left tube.Finally, on (b)(6) 2019, one of the essures was removed without fragmenting, however, for the removal of the other they have to perform a left salpingectomy (left fallopian tube removal); extracting the device fragmented.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - in (b)(6) 2015: implantation of two essure devices and the dubious location of at least one of them was noted; on (b)(6) 2019: confirms the existence of two left essures, one of myometrial location with exit to the peroneum (that is, in the uterus) and another partially located in the left tube, confirming the incorrect location already suspected in previous reports.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain lower ('chronic pain in the left iliac fossa'), device breakage ('device fragmented') and uterine perforation ('one of them poorly located / incorrect location / one of myometrial location with exit to the peroneum') in a 32-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use issue "two inserts placed in one tube".The patient's medical history included pre-eclampsia in 2009, stillbirth nos in 2009, parity 2, kidney failure and female sterilisation.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), uterine perforation (seriousness criterion medically significant), discomfort ("persistent discomfort") and allergy to metals ("allergic to nickel").The patient was treated with surgery (essure removal and left salpingectomy for extraction of the fragmented device).Essure was removed on (b)(6) 2019.At the time of the report, the abdominal pain lower, device breakage, uterine perforation, discomfort and allergy to metals outcome was unknown.The reporter considered abdominal pain lower, allergy to metals, device breakage, discomfort and uterine perforation to be related to essure.The reporter commented: during the pregnancy tests carried out in 2009, she was detected to have high blood pressure.On (b)(6) 2009, she went to the emergency room for severe abdominal pain and metrorrhagia, and after an ultrasound scan it was detected that the fetus was dead.Being pregnant again in 2010, in early (b)(6), and in view of the suspicion of iugr (intrauterine growth restriction) and peg (small baby for age) as well as oligohydramnios (decrease in amniotic fluid below the normal level for gestational age), it was decided to induce labor.After miscarriage in (b)(6) 2014, she become pregnant again in (b)(6) 2014.During the pregnancy controls carried out, she was diagnosed with kell antigen, so a caesarean section was scheduled for (b)(6) 2015 (week 37 of gestation).It was also decided to perform tubal ligation, the e right tube was tied, but the left tube cannot be tied because it had an important adhesion syndrome.On (b)(6) 2015, two essure devices were inserted into her left tube.Finally, on (b)(6) 2019, one of the essures was removed without fragmenting, however, for the removal of the other they have to perform a left salpingectomy (left fallopian tube removal); extracting the device fragmented.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - in (b)(6) 2015: implantation of two essure devices and the dubious location of at least one of them was noted; on (b)(6) 2019: confirms the existence of two left essures, one of myometrial location with exit to the peroneum (that is, in the uterus) and another partially located in the left tube, confirming the incorrect location already suspected in previous reports.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-mar-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain lower ('chronic pain in the left iliac fossa'), device breakage ('device fragmented') and uterine perforation ('one of them poorly located / incorrect location / one of myometrial location with exit to the peroneum') in a 32-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use issue "two inserts placed in one tube".The patient's medical history included pre-eclampsia in 2009, stillbirth nos in 2009, parity 2, kidney failure and female sterilisation.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), uterine perforation (seriousness criterion medically significant), discomfort ("persistent discomfort") and allergy to metals ("allergic to nickel").The patient was treated with surgery (essure removal and left salpingectomy for extraction of the fragmented device).Essure was removed on (b)(6) 2019.At the time of the report, the abdominal pain lower, device breakage, uterine perforation, discomfort and allergy to metals outcome was unknown.The reporter considered abdominal pain lower, allergy to metals, device breakage, discomfort and uterine perforation to be related to essure.The reporter commented: during the pregnancy tests carried out in 2009, she was detected to have high blood pressure.On (b)(6), 2009, she went to the emergency room for severe abdominal pain and metrorrhagia, and after an ultrasound scan it was detected that the fetus was dead.Being pregnant again in 2010, in early (b)(6), and in view of the suspicion of iugr (intrauterine growth restriction) and peg (small baby for age) as well as oligohydramnios (decrease in amniotic fluid below the normal level for gestational age), it was decided to induce labor.After miscarriage in (b)(6) 2014, she become pregnant again in (b)(6) 2014.During the pregnancy controls carried out, she was diagnosed with kell antigen, so a caesarean section was scheduled for (b)(6), 2015 (week 37 of gestation).It was also decided to perform tubal ligation, the e right tube was tied, but the left tube cannot be tied because it had an important adhesion syndrome.On (b)(6)2015, two essure devices were inserted into her left tube.Finally, on (b)(6) 2019, one of the essures was removed without fragmenting, however, for the removal of the other they have to perform a left salpingectomy (left fallopian tube removal); extracting the device fragmented.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - in (b)(6) 2015: implantation of two essure devices and the dubious location of at least one of them was noted; on (b)(6) 2019: confirms the existence of two left essures, one of myometrial location with exit to the peroneum (that is, in the uterus) and another partially located in the left tube, confirming the incorrect location already suspected in previous reports.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-mar-2020: quality safety evaluation of ptc based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ('chronic pain in the left iliac fossa / recurrent hypogastrium pain'), device breakage ('device fragmented') and uterine perforation ('one of them poorly located / incorrect location / one of myometrial location with exit to the 10mm peritoneum') in a 32-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: medical device monitoring error "it was decided to implant the essure device only in the left tube." on (b)(6) 2015 and device use issue "two inserts placed in one tube/two essure are seen in left tube".The patient's medical history included female sterilisation (it is not possible to tie the left tube, the patient has a significant adherence syndrome that prevents access to left tube.) on (b)(6) 2015, abruptio placentae (3rd pregnancy) in 2014, miscarriage in (b)(6) 2014, intrauterine growth retardation (2nd pregnancy) in 2010, oligohydramnios (2nd pregnancy) in 2010, pre-eclampsia in 2009, stillbirth nos (on (b)(6) 2009, she went to the emergency room for severe abdominal pain and metrorrhagia, and after an ultrasound scan it was detected that the fetus was dead.) in 2009, parity 3 and kidney failure.No known allergies.Previously administered products included for an unreported indication: blood transfusion.Concomitant products included oral contraceptive nos.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2016, the patient experienced dysuria ("dysuria / voiding syndrome").In 2016, the patient experienced abdominal pain lower (seriousness criteria hospitalization, medically significant and intervention required) and amenorrhoea ("the amount of bleeding with menstruation has decreased agravated to amenorrhea of more than a month").On (b)(6) 2017, the patient experienced medical device discomfort ("discomfort with essure / discomfort").On (b)(6) 2017, the patient experienced pelvic pain ("chronic pain").On (b)(6) 2019, the patient experienced ovulation pain ("abdominal pain in relation to ovulation") and dysmenorrhoea ("dysmenorrhea").On (b)(6) 2019, the patient experienced uterine perforation (seriousness criterion medically significant).On 14-mar-2019, the patient experienced dizziness ("dizziness"), vomiting ("vomiting") and nausea ("nausea").On (b)(6) 2019, the patient experienced post procedural discharge ("seropurulent discharge per laparoscopic point after essure removal via laparoscopic salpinguectomy on (b)(6) 2019") and procedural pain ("pain in the central abdominal after essure removal via laparoscopic salpinguectomy on (b)(6) 2019").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), allergy to metals ("allergic to nickel") and headache ("headache").The patient was hospitalized from (b)(6) 2019 to (b)(6) 2019.The patient was treated with dexketoprofen, metamizole, metamizole magnesium (nolotil), omeprazole, paracetamol and surgery (essure removal via laparoscopic salpinguectomy for removal of 2 essure on (b)(6) 2019 and left salpingectomy for extraction of the fragmented device).Essure was removed on (b)(6) 2019.At the time of the report, the abdominal pain lower was resolving, the device breakage, uterine perforation, pelvic pain, allergy to metals, ovulation pain, dysmenorrhoea, dizziness, vomiting, nausea, post procedural discharge, procedural pain and medical device discomfort outcome was unknown, the amenorrhoea had resolved and the dysuria had not resolved.The reporter considered abdominal pain lower, allergy to metals, amenorrhoea, device breakage, dizziness, dysmenorrhoea, dysuria, headache, medical device discomfort, nausea, ovulation pain, pelvic pain, post procedural discharge, procedural pain, uterine perforation and vomiting to be related to essure.The reporter commented: on (b)(6) 2015, two essure devices were inserted into her left tube,4 rings are visualized.It is indicated to continue with contraceptives for three months.Finally, on (b)(6) 2019, one of the essures was removed without fragmenting, however, for the removal of the other they have to perform a left salpingectomy (left fallopian tube removal); extracting the device fragmented.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on (b)(6) 2019: positive for nickel sulfate (+++), manganese chloride (++) and weak for ferrous chloride.C-reactive protein - on (b)(6) 2019: 3.8.Computerised tomogram - on (b)(6) 2019: two left essures are observed; on (b)(6) 2019: two essures on the left, one in myometrial location with a 10 m peritoneum outlet and the other partially located in the left tube.Pregnancy test - on (b)(6) 2016: negative.Specialist consultation - on (b)(6) 2017: gynecology consultation.The patient has reported discomfort and chronic pain in fossa iliac for a year that she attributes to the device.There is no relevant gynecological history to justify the pain.She does not report allergies; on (b)(6) 2019: gynecology consultation.The patient has reported discomfort and chronic pain in fossa iliac that she attributes to the device; on (b)(6) 2019: soft and depressible abdome, she refers to pain on examination, radiating to the gluteus.Discomfort not attributable to device intrafallopian; on (b)(6) 2019: painful abdomen in the hypogastrium, voluntary defense and no signs of clear peritonism at this time; on (b)(6) 2019: examination soft and depressible abdomen, scars in good condition.,ge and vagina normal, normal touch, she is very well, she refers that the chronic pelvic pain she had has subsided.However, she maintains a clinic for morning sickness and headache.Ultrasound scan vagina - on (b)(6) 2017: unremarkable; on (b)(6) 2017: it is noted that the ultrasound is normal.Essure well placed and visualized; on (b)(6) 2019: two left essures are observed; on (b)(6) 2019: uterus in indifferent position, normal right ovary, non-visualized left ovary, no free fluid; on (b)(6) 2019: no free liquid is observed.Analytics within normality; on (b)(6) 2019: uterus in a vf with both adnexa normal.No free liquid.Urine analysis - on (b)(6) 2016: urine strip: nitrites +, normal leukocytes, negative ppr.White blood cell count - on (b)(6) 2019 leukocytes without deviation to the left.X-ray - on (b)(6) 2015: implantation of two essure devices and the dubious location of at least one of them was noted; on (b)(6) 2015: two essure are seen in the left tube, apparently in adequate location; on (b)(6) 2019: confirms the existence of two left essures, one of myometrial location with exit to the peroneum (that is, in the uterus) and another partially located in the left tube, confirming the incorrect location already suspected in previous reports.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-jun-2021: the follow information were updated: lawyer's and hcp's reporter.Medical history, historical drug, lab results, product indication, other concomitant and treatment products were provided.New events were reported: amenorrhea, dysuria, dysmenorrhea, ovulation pain, nausea, dizziness, allergy to metals, postoperative pain, postoperative discharge, headache, discomfort with essure was added to discomfort nos and updated to medical device pain, onset date added to uterine perforation.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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