| Model Number ESS305 |
| Device Problems
Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Autoimmune Disorder (1732); Hair Loss (1877); Memory Loss/Impairment (1958); Pain (1994); Anxiety (2328); Cognitive Changes (2551); Heavier Menses (2666)
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("extreme, constant, and unbearable pain") and coeliac disease ("celiac disease") in a female patient who received essure for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient started essure.In (b)(6) 2016, the patient experienced procedural pain ("following the explant procedure, plaintiff suffered a painful post-operative recovery").On an unknown date, the patient experienced pelvic pain (serious criteria medically significant and clinically significant/intervention required), coeliac disease (serious criterion medically significant) with gastric disorder, vitamin d deficiency and alopecia, menorrhagia ("her menstrual cycle became increasingly very heavy"), amnesia ("memory loss"), disturbance in attention ("was unable to concentrate") and anxiety ("emotional anguish").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016 - both essure removed from the fallopian tubes isthmus region).Essure was withdrawn.At the time of the report, the pelvic pain, procedural pain and anxiety outcome was unknown and the coeliac disease, menorrhagia, amnesia and disturbance in attention outcome was unknown.The reporter considered pelvic pain, coeliac disease, menorrhagia, amnesia, disturbance in attention, procedural pain and anxiety to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): on (b)(6) 2014: hysterosalpingogram result was satisfactory placement of both essure coils (cont).On (b)(6) 2014: ultrasound scan result was devices in a similar position as the previous hsg.On (b)(6) 2014: ultrasound scan result was echogenic line of essure seen distal to left cornu.On (b)(6) 2014: hysterosalpingogram (cont.) - and full occlusion of both tubes.On (b)(6) 2014: computerised tomogram - lateral tip of the left essure implant did not appear to be in uterine or tubal tissue.On (b)(6) 2014: ultrasound scan (cont.) - and the right essure device appeared more lateral.Company causality comment: this spontaneous case report refers to a female plaintiff who had essure inserted and experienced extreme, constant, and unbearable pain (seen as pelvic pain) and celiac disease (coeliac disease).Plaintiff underwent bilateral salpingectomy, almost two and a half years after essure insertion.Pelvic pain is anticipated whereas coeliac disease is unanticipated in the reference safety information for essure.During essure therapy, pelvic pain may occur.Considering that event started after essure implant and the lack of alternative explanations, causality with essure cannot be excluded.Considering the pathophysiology of autoimmune disorders and local action of essure at the fallopian tubes, a causal relationship between coeliac disease and essure is assessed as unrelated.This case was regarded as incident, as a surgical intervention was required.A product technical analysis is being sought.Further information will be obtained through the litigation process.
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Manufacturer Narrative
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Quality-safety evaluation of ptc: sample not available.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.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are 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.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 24-jan-2017: quality safety evaluation of ptc.Company causality comment: this spontaneous case report refers to a female plaintiff who had essure inserted and experienced extreme, constant, and unbearable pain (seen as pelvic pain) and celiac disease (coeliac disease).Plaintiff underwent bilateral salpingectomy, almost two and a half years after essure insertion.Pelvic pain is anticipated whereas coeliac disease is unanticipated in the reference safety information for essure.During essure therapy, pelvic pain may occur.Considering that event started after essure implant and the lack of alternative explanations, causality with essure cannot be excluded.Considering the pathophysiology of autoimmune disorders and local action of essure at the fallopian tubes, a causal relationship between coeliac disease and essure is assessed as unrelated.This case was regarded as incident, as a surgical intervention was required.A product quality defect could not be confirmed but is considered plausible.However, the reported medical events are not indicative of a quality deficit per se.Further information will be obtained through the litigation process.
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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 ("extreme, constant, and unbearable pain"), coeliac disease ("celiac disease / autoimmune disorder- celiac disease / gastrointestinal or digestive system condition celiac") and genital haemorrhage ("abnormal bleeding / abnormal bleeding (vaginal, menorrhagia)") in a (b)(6) year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida and parity 3 (date of births: (b)(6) 2007; (b)(6) 2011; (b)(6) 2012).Previously administered products included for an unreported indication: mirena iud.Concurrent conditions included obesity, gerd, intestinal intraepithelial lymphocytes increased, left lower quadrant pain, spotting between menses and gastropathy.Concomitant products included colecalciferol (vitamin d), esomeprazole magnesium (nexium), ibuprofen, ibuprofen (advil), ibuprofen (motrin), medroxyprogesterone (depo provera) and ranitidine hydrochloride (zantac).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced coeliac disease (seriousness criterion medically significant) with gastric disorder, vitamin d deficiency and alopecia, dysmenorrhoea ("dysmenorrhea") and abdominal pain lower ("pain/ lower abdominal pain and often on the right side").In (b)(6) 2013, the patient experienced migraine ("migraines"), headache ("headaches") and nausea ("nausea").In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding / abnormal bleeding (vaginal, menorrhagia)"), amnesia ("memory loss / psychiatric problems- memory loss") and allergy to metals ("nickel allergy").In (b)(6) 2016, the patient experienced procedural pain ("following the explant procedure, plaintiff suffered a painful post-operative recovery").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("her menstrual cycle became increasingly very heavy"), disturbance in attention ("was unable to concentrate"), anxiety ("emotional anguish") and fatigue ("fatigue").The patient was treated with surgery (laparoscopic bilateral salpingectomy with removal of essure device).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, coeliac disease, genital haemorrhage, vaginal haemorrhage, menorrhagia, amnesia, disturbance in attention, procedural pain, anxiety, migraine, headache, nausea, allergy to metals, dysmenorrhoea, fatigue and abdominal pain lower had resolved.The reporter considered abdominal pain lower, allergy to metals, amnesia, anxiety, coeliac disease, disturbance in attention, dysmenorrhoea, fatigue, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, procedural pain and vaginal haemorrhage to be related to essure.The reporter commented: first, the left ostium was visualized and the essure device was deployed, leaving 6-7 coils outside the ostium.The right ostium was then visualized and the essure device was inserted and deployed, leaving about 3 coils outside the ostium.At this point, the hysteroscope was removed.In doing some research, patient has noted that there is a potential association between the iud essure and the inflammation that it causes potentially precipitating inflammatory conditions like celiac and other autoimmune illness diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 37.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: satisfactory placement of both essure coils (cont); on (b)(6) 2016: complete bilateral occlusion of fallopian tubes ultrasound scan - on (b)(6) 2014: devices in a similar position as the previous hsg; on (b)(6) 2014: echogenic line of essure seen distal to left cornu; on (b)(6) 2016: essure device in the bilateral uterine cornu (b)(6) 2014: hysterosalpingogram (cont.) - and full occlusion of both tubes/ total bilateral occlusion and normal positioning (b)(6) 2014: computerised tomogram - lateral tip of the left essure implant did not appear to be in uterine or tubal tissue.(b)(6) 2014: ultrasound scan (cont.) - and the right essure device appeared more lateral.(b)(6) 2013:pathology report: iud: - contraceptive device.Polyp polypoid uterine tissue with organizing fibrin, chronic inflammation, fibrosis, calcifications and hemosiderin; rare microscopic hyalinized focusing the possibility of hyalinized villi; no diagnostic trophoblast is identified.(b)(6) 2014:pathology report:gastrointestinal mucosal biopsies : gastroesophageal junction: - squamous mucosa, with normal limits.- no glandular tissue present.Antrum: within normal limits.Antrum ulcer: - chemical - type gastropathy; immunohistochemical stain for helicobacter is negative with adequate controls.Duodenal bulb : - small intestinal mucosa with normal villous architecture and focal mild increase in intraepithelial lymphocytes , see note.End part of duodenum: - small intestinal mucosa with normal villous architecture and focal mild increase in intraepithelial lymphocytes , see note.Note : the findings are non - specific but raise the possibility of celiac disease.(b)(6) 2014:anti dgp-77.(b)(6) 2014-transabdominal sonography:although neither ovary is visualized, no adnexal mass is identified.No free fluid seen in the pelvis.Thin endometrium.The echogenic line of the essure device is seen appropriately distal to the left cornua, however, the right essure device appears more lateral and is not well visualized transvaginally.Correlation with any confirmation hsg performed after essure.Insertion is recommended to ensure proper positioning of the devices.(b)(6) 2014:pathology report:duodenal mucosal biopsies , two :.Bulb : two fragments of duodenal mucosa with predominantly intact villi and no increase in intraepithelial lymphocytes.Second portion: eight fragments of duodenal mucosa with variable , subtotal villous shortening and crypt hyperplasia , and a mild increase in intraepithelial lymphocytes consistent with celiac disease in the appropriate clinical and serologic settings.(b)(6) 2016:transabdominal and transvaginal imaging:normal measuring 9.3 x 3.655 cm.The endometrium is normal measuring 0.5 cm.In the region the bilateral cornu, there is a in the short device seen.Ovaries : the right and left ovary have normal echotexture vascularity measuring 3 x 2.8 x 2.5 cm and 2.4 x 1.2 x 2.2 cm respectively impression : essure device in the bilateral uterine cornu.Adequate placement can be confirmed with pelvic plain film.(b)(6) 2016: abdomen rad:tubal occlusion devices which appear in a generally similar position to that on the hysterosalpingogram from (b)(6) 2014.Quality-safety evaluation of ptc: sample not available.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.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are 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.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 29-jan-2018: plantiff fact sheet & medical record received.Events abnormal bleeding , migraines/headaches, nausea,nickel allergy, dysmenorrhea,fatigue,hair loss,pain/ lower abdominal pain and often on the right side are added.Concomitant condition & drug are added.Historical condition & drug are added.Patient , product & reporter information added.¿essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only¿ 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.
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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 ('extreme, constant, and unbearable pain') in a 24-year-old female patient who had essure (batch no.M418ess3051-inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, parity 3 (date of births: (b)(6) 2007; (b)(6) 2011; (b)(6) 2012), low back pain and libido decreased.Previously administered products included for an unreported indication: mirena iud.Concurrent conditions included obesity, gerd, intestinal intraepithelial lymphocytes increased, left lower quadrant pain, spotting between menses, chemical gastropathy, epigastric pain, breast pain, earache, dysuria, vaginal burning sensation and irregular periods.Concomitant products included esomeprazole, ibuprofen, ibuprofen, ibuprofen (motrin), medroxyprogesterone acetate (depo provera), ranitidine hydrochloride (zantac) and vitamin d nos (vitamin d).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced coeliac disease ("celiac disease / autoimmune disorder- celiac disease / gastrointestinal or digestive system condition celiac") with gastric disorder, vitamin d deficiency and alopecia, dysmenorrhoea ("dysmenorrhea (cramping)") and abdominal pain lower ("pain/ lower abdominal pain and often on the right side").In (b)(6) 2013, the patient experienced migraine ("migraines"), headache ("headaches"), nausea ("nausea") and fatigue ("fatigue").In 2014, the patient experienced genital haemorrhage ("abnormal bleeding / abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding / abnormal bleeding (vaginal, menorrhagia)") and amnesia ("memory loss / psychiatric problems- memory loss").In (b)(6) 2014, the patient experienced allergy to metals ("nickel allergy").In (b)(6) 2016, the patient experienced procedural pain ("following the explant procedure, plaintiff suffered a painful post-operative recovery").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("her menstrual cycle became increasingly very heavy"), disturbance in attention ("was unable to concentrate") and anxiety ("emotional anguish").The patient was treated with surgery (laparoscopic bilateral salpingectomy with removal of essure device).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, coeliac disease, genital haemorrhage, vaginal haemorrhage, menorrhagia, amnesia, disturbance in attention, procedural pain, anxiety, migraine, headache, nausea, allergy to metals, dysmenorrhoea, fatigue and abdominal pain lower had resolved.The reporter considered abdominal pain lower, allergy to metals, amnesia, anxiety, coeliac disease, disturbance in attention, dysmenorrhoea, fatigue, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, procedural pain and vaginal haemorrhage to be related to essure.The reporter commented: first, the left ostium was visualized and the essure device was deployed, leaving 6-7 coils outside the ostium.The right ostium was then visualized and the essure device was inserted and deployed, leaving about 3 coils outside the ostium.At this point, the hysteroscope was removed.In doing some research, patient has noted that there is a potential association between the iud essure and the inflammation that it causes potentially precipitating inflammatory conditions like celiac and other autoimmune illness.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 37.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: results: satisfactory placement of both essure coils (cont); on (b)(6) 2016: results: complete bilateral occlusion of fallopian tubes.Ultrasound scan - on (b)(6) 2014: results: devices in a similar position as the previous hsg; on (b)(6) 2014: results: echogenic line of essure seen distal to left cornu; on (b)(6) 2016: results: essure device in the bilateral uterine cornu.(b)(6) 2014: hysterosalpingogram (cont.) - and full occlusion of both tubes/ total bilateral occlusion and normal positioning (b)(6) 2014: computerised tomogram - lateral tip of the left essure implant did not appear to be in uterine or tubal tissue.(b)(6) 2014: ultrasound scan (cont.) - and the right essure device appeared more lateral.(b)(6) 2013:pathology report:1.Iud: - contraceptive device 2.Polyp polypoid uterine tissue with organizing fibrin, chronic inflammation, fibrosis, calcifications and hemosiderin; rare microscopic hyalinized focusing the possibility of hyalinized villi; no diagnostic trophoblast is identified.(b)(6) 2014:pathology report:gastrointestinal mucosal biopsies : 1 ) gastroesophageal junction: - squamous mucosa, with normal limits.- no glandular tissue present.2 ) antrum: within normal limits.3) antrum ulcer: - chemical - type gastropathy; immunohistochemical stain for helicobacter is negative with adequate controls.4) duodenal bulb : - small intestinal mucosa with normal villous architecture and focal mild increase in intraepithelial lymphocytes , see note.5 ) end part of duodenum: - small intestinal mucosa with normal villous architecture and focal mild increase in intraepithelial lymphocytes , see note.Note : the findings are non - specific but raise the possibility of celiac disease.(b)(6) 2014:anti dgp-77 (b)(6) 2014-transabdominal sonography:although neither ovary is visualized, no adnexal mass is identified.No free fluid seen in the pelvis.Thin endometrium.The echogenic line of the essure device is seen appropriately distal to the left cornua, however, the right essure device appears more lateral and is not well visualized transvaginally.Correlation with any confirmation hsg performed after essure.Insertion is recommended to ensure proper positioning of the devices.(b)(6) 2014:pathology report:duodenal mucosal biopsies , two : 1.Bulb : two fragments of duodenal mucosa with predominantly intact villi and no increase in intraepithelial lymphocytes.2.Second portion: eight fragments of duodenal mucosa with variable , subtotal villous shortening and crypt hyperplasia , and a mild increase in intraepithelial lymphocytes consistent with celiac disease in the appropriate clinical and serologic settings (b)(6) 2016:transabdominal and transvaginal imaging:normal measuring 9.3 x 3.655 cm.The endometrium is normal measuring 0.5 cm.In the region the bilateral cornu, there is a in the short device seen.Ovaries : the right and left ovary have normal echotexture vascularity measuring 3 x 2.8 x 2.5 cm and 2.4 x 1.2 x 2.2 cm respectively impression : essure device in the bilateral uterine cornu.Adequate placement can be confirmed with pelvic plain film.(b)(6) 2016: abdomen rad:tubal occlusion devices which appear in a generally similar position to that on the hysterosalpingogram from (b)(6) 2014 lot # m418ess3051- invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 12-may-2020: quality-safety evaluation of product technical complaint.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 lawyer and describes the occurrence of pelvic pain ('extreme, constant, and unbearable pain') in a 24-year-old female patient who had essure (batch no.M418ess3051) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, parity 3 (date of births: (b)(6) 2007; (b)(6) 2011; (b)(6) 2012, low back pain and libido decreased.Previously administered products included for an unreported indication: mirena iud.Concurrent conditions included obesity, gerd, intestinal intraepithelial lymphocytes increased, left lower quadrant pain, spotting between menses, chemical gastropathy, epigastric pain, breast pain, earache, dysuria, vaginal burning sensation and irregular periods.Concomitant products included esomeprazole, ibuprofen, ibuprofen, ibuprofen (motrin), medroxyprogesterone acetate (depo provera), ranitidine hydrochloride (zantac) and vitamin d nos (vitamin d).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced coeliac disease ("celiac disease / autoimmune disorder- celiac disease / gastrointestinal or digestive system condition celiac") with gastric disorder, vitamin d deficiency and alopecia, dysmenorrhoea ("dysmenorrhea cramping") and abdominal pain lower ("pain/ lower abdominal pain and often on the right side").In (b)(6) 2013, the patient experienced migraine ("migraines"), headache ("headaches"), nausea ("nausea") and fatigue ("fatigue").In 2014, the patient experienced genital haemorrhage ("abnormal bleeding / abnormal bleeding vaginal, menorrhagia"), vaginal haemorrhage ("abnormal bleeding / abnormal bleeding vaginal, menorrhagia") and amnesia ("memory loss / psychiatric problems- memory loss").In (b)(6) 2014, the patient experienced allergy to metals ("nickel allergy").In (b)(6) 2016, the patient experienced procedural pain ("following the explant procedure, plaintiff suffered a painful post-operative recovery").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("her menstrual cycle became increasingly very heavy"), disturbance in attention ("was unable to concentrate") and anxiety ("emotional anguish").The patient was treated with surgery (laparoscopic bilateral salpingectomy with removal of essure device).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, coeliac disease, genital haemorrhage, vaginal haemorrhage, menorrhagia, amnesia, disturbance in attention, procedural pain, anxiety, migraine, headache, nausea, allergy to metals, dysmenorrhoea, fatigue and abdominal pain lower had resolved.The reporter considered abdominal pain lower, allergy to metals, amnesia, anxiety, coeliac disease, disturbance in attention, dysmenorrhoea, fatigue, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, procedural pain and vaginal haemorrhage to be related to essure.The reporter commented: first, the left ostium was visualized and the essure device was deployed, leaving 6-7 coils outside the ostium.The right ostium was then visualized and the essure device was inserted and deployed, leaving about 3 coils outside the ostium.At this point, the hysteroscope was removed.In doing some research, patient has noted that there is a potential association between the iud essure and the inflammation that it causes potentially precipitating inflammatory conditions like celiac and other autoimmune illness.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 37.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: results: satisfactory placement of both essure coils (cont); on (b)(6) 2016: results: complete bilateral occlusion of fallopian tubes.Ultrasound scan - on (b)(6) 2014: results: devices in a similar position as the previous hsg; on (b)(6) 2014: results: echogenic line of essure seen distal to left cornu; on (b)(6) 2016: results: essure device in the bilateral uterine cornu.(b)(6) 2014: hysterosalpingogram (cont.) - and full occlusion of both tubes/ total bilateral occlusion and normal positioning (b)(6) 2014: computerised tomogram - lateral tip of the left essure implant did not appear to be in uterine or tubal tissue.(b)(6) 2014: ultrasound scan (cont.) - and the right essure device appeared more lateral.(b)(6) 2013:pathology report:1.Iud: - contraceptive device.2.Polyp polypoid uterine tissue with organizing fibrin, chronic inflammation, fibrosis, calcifications and hemosiderin; rare microscopic hyalinized focusing the possibility of hyalinized villi; no diagnostic trophoblast is identified.(b)(6) 2014:pathology report:gastrointestinal mucosal biopsies : 1 ) gastroesophageal junction: squamous mucosa, with normal limits.No glandular tissue present.2 ) antrum: within normal limits.3) antrum ulcer: chemical - type gastropathy; immunohistochemical stain for helicobacter is negative with adequate controls.4) duodenal bulb : small intestinal mucosa with normal villous architecture and focal mild increase in intraepithelial lymphocytes , see note.5 ) end part of duodenum: - small intestinal mucosa with normal villous architecture and focal mild increase in intraepithelial lymphocytes , see note.Note : the findings are non - specific but raise the possibility of celiac disease.(b)(6) 2014:anti dgp-77.(b)(6) 2014-transabdominal sonography:although neither ovary is visualized, no adnexal mass is identified.No free fluid seen in the pelvis.Thin endometrium.The echogenic line of the essure device is seen appropriately distal to the left cornua, however, the right essure device appears more lateral and is not well visualized transvaginally.Correlation with any confirmation hsg performed after essure.Insertion is recommended to ensure proper positioning of the devices.(b)(6) 2014:pathology report:duodenal mucosal biopsies , two : 1.Bulb : two fragments of duodenal mucosa with predominantly intact villi and no increase in intraepithelial lymphocytes.2.Second portion: eight fragments of duodenal mucosa with variable , subtotal villous shortening and crypt hyperplasia , and a mild increase in intraepithelial lymphocytes consistent with celiac disease in the appropriate clinical and serologic settings.(b)(6) 2016:transabdominal and transvaginal imaging:normal measuring 9.3 x 3.655 cm.The endometrium is normal measuring 0.5 cm.In the region the bilateral cornu, there is a in the short device seen.Ovaries : the right and left ovary have normal echotexture vascularity measuring 3 x 2.8 x 2.5 cm and 2.4 x 1.2 x 2.2 cm respectively impression : essure device in the bilateral uterine cornu.Adequate placement can be confirmed with pelvic plain film.(b)(6) 2016: abdomen rad:tubal occlusion devices which appear in a generally similar position to that on the hysterosalpingogram from (b)(6) 2014.Quality-safety evaluation of ptc: sample not available.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.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are 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.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 13-apr-2020: pfs+mr received.Lot number added.New reporters, medical history and concomitant conditions added.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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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