| Model Number ESS305 |
| Device Problems
Break (1069); Material Fragmentation (1261); Difficult to Remove (1528); Biocompatibility (2886)
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| Patient Problems
Pain (1994); Rash (2033); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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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 pelvic pain ("sharp, stabbing pain on her right side") in a female patient who received essure.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient started essure.On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization and clinically significant/intervention required).The patient was treated with surgery (essure removed through a hysterectomy).During removal procedure, she experienced device breakage and complication of device removal ("during her removal procedure, a power morcellator left metal fragments behind").At the time of the report, the pelvic pain, device breakage, complication of device removal and rash had not resolved.The reporter provided no causality assessment for pelvic pain, device breakage, complication of device removal and rash with essure.Company causality comment: this spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced a sharp, stabbing pain on her right side.Consumer underwent a hysterectomy to have essure removed; however, during her removal procedure, a power morcellator left metal fragments behind (seen as device breakage).At time of report, consumer had not recovered.Both these events are anticipated in the reference safety information for essure.Pelvic pain may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between this event and suspect insert cannot be excluded.In this present case, essure coils broke during removal procedure and thus, causality cannot be excluded.This case was regarded as incident since intervention was required (device removal by hysterectomy).A product technical analysis is being sought.No further information is expected as consumer contact is not available.
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Manufacturer Narrative
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Quality-safety evaluation of ptc: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The inserts outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.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, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 20-mar-2017: ptc investigation result was provided.The ptc global number is (b)(4).Company causality comment: this spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced a sharp, stabbing pain on her right side.Consumer underwent a hysterectomy to have essure removed; however, during her removal procedure, a power morcellator left metal fragments behind (seen as device breakage).At time of report, consumer had not recovered.These both events are anticipated in the reference safety information for essure.Pelvic pain may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between this event and suspect insert cannot be excluded.In this present case, essure coils broke during removal procedure and thus, causality cannot be excluded.This case was regarded as incident since intervention was required (device removal by hysterectomy).The product quality analysis concluded that as a defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.No further information is expected as consumer contact is not available.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("sharp, stabbing pain on her right side") and ovarian cyst ("cysts/ ovarian cyst") in an adult female patient who had essure (batch no.761434) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included dysmenorrhea on (b)(6) 2011, vaginal discharge on (b)(6) 2011, post coital bleeding on (b)(6) 2011, incontinence on (b)(6) 2011, acute pharyngitis on (b)(6) 2012 and acute sinusitis on (b)(6) 2012.Smoking status ¿ never smoked.Previously administered products included for an unreported indication: cytotec on (b)(6) 2011 and loestrin on (b)(6) 2011.Concurrent conditions included dizzy, nauseated, fatigue, diarrhea, vomiting, cramp in lower abdomen, heavy periods, menorrhagia, bleeding menstrual heavy, paraesthesia upper limb, numbness of upper extremities, itchy rash since (b)(6) 2012, allergy since (b)(6) 2012, bronchitis since (b)(6) 2012 and asthma since (b)(6) 2012.Concomitant products included prednisone for rash as well as ibuprofen, ibuprofen (motrin) and ketorolac tromethamine (toradol).On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage ("during her removal procedure, a power morcellator left metal fragments behind"), ovarian cyst (seriousness criterion medically significant), complication of device removal ("during her removal procedure, a power morcellator left metal fragments behind"), back pain ("back pain"), fatigue ("fatigue"), dyspareunia ("painful sex"), nausea ("nausea"), pain in extremity ("arm pain/ leg pain"), headache ("headache"), premenstrual syndrome ("premenstrual syndrome"), dysmenorrhoea ("dysmenorrhea/menstrual cramps"), abdominal pain lower ("lower abdominal pain"), allergy to metals ("allergic to gold/ nickel allergy") with rash, urticaria, eczema and pruritus and benign neoplasm ("benign cyst on my breast").The patient was treated with surgery (essure removed through a hysterectomy (uterus morcellated)) and surgery (laparoscopically).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, device breakage and complication of device removal had not resolved and the ovarian cyst, back pain, fatigue, dyspareunia, nausea, pain in extremity, headache, premenstrual syndrome, dysmenorrhoea, abdominal pain lower, allergy to metals and benign neoplasm outcome was unknown.The reporter considered pelvic pain to be related to essure.The reporter provided no causality assessment for abdominal pain lower, allergy to metals, back pain, benign neoplasm, complication of device removal, device breakage, dysmenorrhoea, dyspareunia, fatigue, headache, nausea, ovarian cyst, pain in extremity and premenstrual syndrome with essure.Diagnostic results: she had a mammogram, ultrasound and mri.All test confirmed that the lump was fibrocystic and benign.On (b)(6) 2012, she had two abdominal ultrasounds, they revealed she had a complex cyst on left ovary, about the size of a tennis ball, which had caused torsion of ovary and tube.She went back in for another ultrasound (b)(6) 2013, with no findings.On (b)(6) 2012, her pap (papanicolaou test) smear test was found to be free from cancerous or precancerous abnorm.On (b)(6) 2011, mri (magnetic resonance imaging) of breast - impression: no suspicious or abnormal areas of enhancement and bilateral retropectoral saline prostheses which appear intact.On (b)(6) 2011, mammography - impression: indeterminate finding in the area of palpable nodularity location in the right breast which may represent a sebaceous cyst.On (b)(6) 2011, hcg (human chorionic gonadotropin test) test was negative and hysterosalpingography impression: non-filling of the distal fallopian tubes secondary to essure devices.On (b)(6) 2012, surgical pathology report - final diagnosis: mature cystic teratoma gross description: the specimen received in formalin and consists of 4.5x4.0x4.0 ovary.There is no identifiable fallopian tube.On (b)(6) 2012, gyn ultrasound-indication: pelvic pain.Comments on uterus: bilateral essure was identified.On (b)(6) 2013, surgical pathology report - gross description: the specimen received in formalin and consists of morcellated uterus which was 110gramsamd measures 8.4x 8.0x 2.8 cm.The endometrium ranges from 0.2 to 0.4 cm in thickness.On (b)(6) 2014, surgical pathology report - gross description: consists of a 4.2 cm portion of white ¿ tan irregular soft tissue.The specimen is sectioned to reveal a cyst space filled with tangrumous material and hair.Reps in two cassettes.Most recent follow-up information incorporated above includes: on 15-nov-2017: medical record received - all relevant medical history, concurrent condition, concomitant medication, lab test were added, case became medically significant.Events: back pain, fatigue, cysts/ovarian cyst, painful sex, nausea, arm pain/ leg pain, headache, dysmenorrhea/menstrual cramps, premenstrual syndrome, lower abdominal pain, benign cyst on my breast, whole body systemic hives, rash/ rash on lower abdomen/ skin rash/whole body rash for over year, eczema, itching with the symptoms of allergic to gold/ nickel allergy were 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.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("sharp, stabbing pain on her right side") and ovarian cyst ("cysts/ ovarian cyst") in an adult female patient who had essure (batch no.761434) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included dysmenorrhea on (b)(6) 2011, vaginal discharge on (b)(6) 2011, post coital bleeding on (b)(6) 2011, incontinence on (b)(6) 2011, acute pharyngitis on (b)(6) 2012 and acute sinusitis on (b)(6) 2012.*smoking status ¿ never smoked.Previously administered products included for an unreported indication: cytotec on (b)(6) 2011 and loestrin on (b)(6) 2011.Concurrent conditions included dizzy, nauseated, fatigue, diarrhea, vomiting, cramp in lower abdomen, heavy periods, menorrhagia, bleeding menstrual heavy, paraesthesia upper limb, numbness of upper extremities, itchy rash since september 2012, allergic cough since (b)(6) 2012, bronchitis since (b)(6) 2012 and asthma since (b)(6) 2012.Concomitant products included prednisone for rash as well as ibuprofen, ibuprofen (motrin) and ketorolac tromethamine (toradol).On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage ("during her removal procedure, a power morcellator left metal fragments behind"), ovarian cyst (seriousness criterion medically significant), complication of device removal ("during her removal procedure, a power morcellator left metal fragments behind"), back pain ("back pain"), fatigue ("fatigue"), dyspareunia ("painful sex"), nausea ("nausea"), pain in extremity ("arm pain/ leg pain"), headache ("headache"), premenstrual syndrome ("premenstrual syndrome"), dysmenorrhoea ("dysmenorrhea/menstrual cramps"), abdominal pain lower ("lower abdominal pain"), allergy to metals ("allergic to gold/ nickel allergy") with rash generalised, urticaria, eczema and pruritus and benign breast neoplasm ("benign cyst on my breast").The patient was treated with surgery (essure removed through a hysterectomy (uterus morcellated)) and surgery (laparoscopically).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, device breakage and complication of device removal had not resolved and the ovarian cyst, back pain, fatigue, dyspareunia, nausea, pain in extremity, headache, premenstrual syndrome, dysmenorrhoea, abdominal pain lower, allergy to metals and benign breast neoplasm outcome was unknown.The reporter provided no causality assessment for abdominal pain lower, allergy to metals, back pain, benign breast neoplasm, complication of device removal, device breakage, dysmenorrhoea, dyspareunia, fatigue, headache, nausea, ovarian cyst, pain in extremity and premenstrual syndrome with essure.The reporter considered pelvic pain to be related to essure.The reporter commented: after hysterectomy, the plaintiff was 99 % symptom free.Diagnostic results: she had a mammogram, ultrasound and mri.All test confirmed that the lump was fibrocystic and benign.On (b)(6) 2012, she had two abdominal ultrasounds, they revealed she had a complex cyst on left ovary, about the size of a tennis ball, which had caused torsion of ovary and tube.She went back in for another ultrasound (b)(6) 2013, with no findings.On (b)(6) 2016, her pap (papanicolaou test) smear test was found to be free from cancerous or precancerous abnorm.On (b)(6) 2011, mri (magnetic resonance imaging) of breast - impression: no suspicious or abnormal areas of enhancement and bilateral retropectoral saline prostheses which appear intact.On 12-sep-2011, mammography - impression: indeterminate finding in the area of palpable nodularity location in the right breast which may represent a sebaceous cyst.On 01-dec-2011, hcg (human chorionic gonadotropin test) test was negative and hysterosalpingography impression: non-filling of the distal fallopian tubes secondary to essure devices.On (b)(6) 2012, surgical pathology report - final diagnosis: mature cystic teratoma gross description: the specimen received in formalin and consists of 4.5x4.0x4.0 ovary.There is no identifiable fallopian tube.On 17-dec-2012, gyn ultrasound-indication: pelvic pain.Comments on uterus: bilateral essure was identified.On (b)(6) 2013, surgical pathology report - gross description: the specimen received in formalin and consists of morcellated uterus which was 110gramsamd measures 8.4x 8.0x 2.8 cm.The endometrium ranges from 0.2 to 0.4 cm in thickness.On (b)(6) 2014, surgical pathology report - gross description: consists of a 4.2 cm portion of white ¿ tan irregular soft tissue.The specimen is sectioned to reveal a cyst space filled with tangrumous material and hair.Reps in two cassettes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-aug-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.
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Search Alerts/Recalls
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