| Model Number ESS305 |
| Device Problems
Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Stroke/CVA (1770); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Thyroid Problems (2102); Uterine Perforation (2121); Abdominal Distention (2601); Heavier Menses (2666); Foreign Body In Patient (2687); No Code Available (3191); Constipation (3274)
|
| Event Date 01/01/2015 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("the left tubal ostia slightly protruding into the endometrial space/device was noted to be imbedded into the myometrial tissue"), device expulsion ("the left tubal ostia slightly protruding into the endometrial space/device was noted to be imbedded into the myometrial tissue"), cerebrovascular accident ("cerebral stroke"), pulmonary mass ("pulmonary nodule") and thyroid mass ("thyroid nodule") in a (b)(6) female patient who had essure (batch no.638495, 20210350) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included obesity.Concomitant products included acetylsalicylic acid (aspirin).On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, device expulsion (seriousness criteria medically significant and intervention required), cerebrovascular accident (seriousness criterion hospitalization), pulmonary mass (seriousness criterion hospitalization), thyroid mass (seriousness criterion hospitalization), menorrhagia ("menorrhagia"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), fatigue ("fatigue"), abdominal distension ("bloating"), constipation ("constipation"), alopecia ("hair loss"), migraine ("migraines"), headache ("headaches"), weight increased ("weight gain") and musculoskeletal pain ("sharp shoulder pains on my left side").The patient was treated with surgery (laparoscopic bilateral salpingectomies and laparoscopic excision of foreign body times there).Essure was removed on (b)(6) 2016.At the time of the report, the embedded device, device expulsion, cerebrovascular accident, pulmonary mass, thyroid mass and constipation outcome was unknown, the menorrhagia, vaginal haemorrhage, fatigue, abdominal distension, migraine, headache, weight increased and musculoskeletal pain was resolving and the alopecia had not resolved.The reporter considered abdominal distension, alopecia, cerebrovascular accident, constipation, device expulsion, embedded device, fatigue, headache, menorrhagia, migraine, musculoskeletal pain, pulmonary mass, thyroid mass, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: date(s) of insertion: (b)(6) 2009 and (b)(6) 2009.Specimens: left fallopian tubes with essure devices times two.Right fallopian tube with essure device times one.To confirm complete removal of all three essure devices, intraoperative fluoroscopy was performed and validated full excision of all the devices and no metallic fragments were seen at the conclusion of the resection.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.5 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: unsuccessful blockage on the right side normal; on (b)(6)2010: left and right side are both blocked successfully.On (b)(6) 2009, the patient underwent fl hysterosalpingography and conclusion: unsuccessful blockage of the right fallopian tube.Normal blockage of the left by the essure devices, both of which appear to be to the left of the midline.The left tubal ostia slightly protruding into the endometrial space/device was noted to be imbedded into the myometrial tissue.Most recent follow-up information incorporated above includes: on 27-feb-2018: pfs and medical record received: reporter information , patient details, other relevant history, lab data, product information, concomitant drug, events- device dislocation, cerebral stroke, pulmonary nodule, thyroid nodule, menorrhagia, abnormal bleeding (vaginal), fatigue, bloating, constipation, hair loss, migraines, headaches, weight gain, sharp shoulder pains on my left side 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.
|
| |
|
Manufacturer Narrative
|
|
Ntaneous case was reported by a lawyer and describes the occurrence of embedded device ("the left tubal ostia slightly protruding into the endometrial space/device was noted to be imbedded into the myometrial tissue"), device expulsion ("the left tubal ostia slightly protruding into the endometrial space/device was noted to be imbedded into the myometrial tissue"), cerebrovascular accident ("cerebral stroke"), pulmonary mass ("pulmonary nodule") and thyroid mass ("thyroid nodule") in a 43-year-old female patient who had essure (batch no.638495, 20210350) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included obesity.Concomitant products included acetylsalicylic acid (aspirin).On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, device expulsion (seriousness criteria medically significant and intervention required), cerebrovascular accident (seriousness criterion hospitalization), pulmonary mass (seriousness criterion hospitalization), thyroid mass (seriousness criterion hospitalization), menorrhagia ("menorrhagia"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), fatigue ("fatigue"), abdominal distension ("bloating"), constipation ("constipation"), alopecia ("hair loss"), migraine ("migraines"), headache ("headaches"), weight increased ("weight gain") and musculoskeletal pain ("sharp shoulder pains on my left side").The patient was treated with surgery (laparoscopic bilateral salpingectomies and laparoscopic excision of foreign body times there) and surgery (laparoscopic bilateral salpingectomies and laparoscopic excision of foreign body times there).Essure was removed on (b)(6) 2016.At the time of the report, the embedded device, device expulsion, cerebrovascular accident, pulmonary mass, thyroid mass and constipation outcome was unknown, the menorrhagia, vaginal haemorrhage, fatigue, abdominal distension, migraine, headache, weight increased and musculoskeletal pain was resolving and the alopecia had not resolved.The reporter considered abdominal distension, alopecia, cerebrovascular accident, constipation, device expulsion, embedded device, fatigue, headache, menorrhagia, migraine, musculoskeletal pain, pulmonary mass, thyroid mass, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: date(s) of insertion: (b)(6) 2009 and (b)(6) 2009.Specimens: left fallopian tubes with essure devices times two.Right fallopian tube with essure device times one.To confirm complete removal of all three essure devices, intraoperative fluoroscopy was performed and validated full excision of all the devices and no metallic fragments were seen at the conclusion of the resection.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.5 kg/sqm.Hysterosalpingogram on (b)(6) 2009: unsuccessful blockage on the right side normal; on (b)(6) 2010: left and right side are both blocked successfully on (b)(6) 2009, the patient underwent fl hysterosalpinography and conclusion: unsuccessful blockage of the right fallopian tube.Normal blockage of the left by the essure devices, both of which appear to be to the left of the midline.The left tubal ostia slightly protruding into the endometrial space/device was noted to be imbedded into the myometrial tissue lot number: 20210350 manufacture date: 2009/09 expiration date: 2012/09, lot number: 638495 manufacture date: 2009/05 expiration date: 2012/05.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of product technical complaint incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("the left tubal ostia slightly protruding into the endometrial space/device was noted to be imbedded into the myometrial tissue"), device expulsion ("the left tubal ostia slightly protruding into the endometrial space/device was noted to be imbedded into the myometrial tissue/ migration of essure device location of device."), cerebrovascular accident ("cerebral stroke"), pulmonary mass ("pulmonary nodule") and thyroid mass ("thyroid nodule") in a 43-year-old female patient who had essure (batch no.638495, 20210350) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included obesity.Concomitant products included acetylsalicylic acid (aspirin).In 2009, the patient experienced menorrhagia ("menorrhagia") and vaginal haemorrhage ("abnormal bleeding (vaginal)") and was found to have weight increased ("weight gain/loss (specify which one) weight gain").On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced fatigue ("fatigue").In 2011, the patient experienced abdominal distension ("gastrointestinal or digestive system: bloating") and constipation ("constipation").In 2013, the patient experienced alopecia ("hair loss").In (b)(6) 2015, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), cerebrovascular accident (seriousness criterion hospitalization), pulmonary mass (seriousness criterion hospitalization) and thyroid mass (seriousness criterion hospitalization).On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, migraine ("migraines"), headache ("headaches"), musculoskeletal pain ("sharp shoulder pains on my left side") and abdominal pain ("abdominal pain").The patient was treated with magnesium, simvastatin (zocor), topiramate (topamax) and surgery (laparoscopic bilateral salpingectomies and laparoscopic excision of foreign body times there).Essure was removed on (b)(6) 2016.At the time of the report, the embedded device, device expulsion, cerebrovascular accident, pulmonary mass, thyroid mass and constipation outcome was unknown, the menorrhagia, vaginal haemorrhage, fatigue, abdominal distension, weight increased, musculoskeletal pain and abdominal pain had resolved, the alopecia had not resolved and the migraine and headache was resolving.The reporter considered abdominal distension, abdominal pain, alopecia, cerebrovascular accident, constipation, device expulsion, embedded device, fatigue, headache, menorrhagia, migraine, musculoskeletal pain, pulmonary mass, thyroid mass, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: date(s) of insertion: (b)(6) 2009 and (b)(6) 2009.Specimens: left fallopian tubes with essure devices times two.Right fallopian tube with essure device times one.To confirm complete removal of all three essure devices, intraoperative fluoroscopy was performed and validated full excision of all the devices and no metallic fragments were seen at the conclusion of the resection.(b)(6) (discrepancy in address) diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.5 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: results: unsuccessful blockage on the right side normal; on (b)(6) 2010: results: left and right side are both blocked successfully; on (b)(6) 2009: results: total bilateral occlusion and unilateral occlusion (left tube occluded).On (b)(6) 2009, the patient underwent fl hysterosalpinography and conclusion: unsuccessful blockage of the right fallopian tube.Normal blockage of the left by the essure devices, both of which appear to be to the left of the midline.The left tubal ostia slightly protruding into the endometrial space/device was noted to be imbedded into the myometrial tissue lot number: 20210350 manufacture date: 2009/09 expiration date: 2012/09.Lot number: 638495 manufacture date: 2009/05 expiration date: 2012/05.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-apr-2019: pfs received.Lab data added.Event abdominal pain added events shoulder pain, abdominal pain, gastrointestinal or digestive system: bloating, fatigue, abnormal bleeding outcomes updated.Incident we received a lot number/returned sample 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
|
|
