| Model Number ESS305 |
| Device Problems
Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265); Migration (4003)
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| Patient Problem
Foreign Body In Patient (2687)
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| Event Date 01/08/2010 |
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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 device dislocation ('migration of essure device location of device: moved distally in the hydrosalpinx') and pregnancy with contraceptive device ('pregnancy (with complications) / pregnancy complicated by ivf pregnancy') in a (b)(6) year old female patient who had essure (batch no.632032,20222097) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida i, parity 1, hirschsprung's disease, hypertension, irritable bowel syndrome, leg pain, unilateral leg swelling, abdominal pain, ovarian cyst and migraine.Concomitant products included amlodipine besilate (amlodipine besylate), diphenhydramine, docusate sodium, ferrous sulfate (ferrous sulphate), lisinopril, paracetamol (acetaminophen), phenazopyridine, rivaroxaban (xarelto), spironolactone, valaciclovir hydrochloride (valtrex), warfarin, warfarin sodium (coumadin), zolpidem and zolpidem tartrate (ambien).On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced pelvic pain ("physical pain"), 9 days after insertion of essure.On (b)(6) 2010, the patient experienced device dislocation (seriousness criterion medically significant).On an unknown date, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition: anxiety and mental anguish").At the time of the report, the device dislocation, pregnancy with contraceptive device, pelvic pain, vaginal haemorrhage, menorrhagia, depression and anxiety outcome was unknown.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.The reporter considered anxiety, depression, device dislocation, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: essure insertion (b)(6) 2009 : the right tube was identified.The left tube identified and the essure device placed.The device did not release.A second device was then attempted.It was threaded successfully into the tubal ostia and placed.The distal tube could not be identified, but upon inspection, the device had been released from the inserter and was not in the uterus.The ball tip was not present as the device was removed from the tubal ostia, confirming intratubal placement.Essure insertion (b)(6) 2010: the ostia were visualized and the essure device was placed into the left tube without difficulty.A second device was attempted in that left tube and the tip was noted to bend.This was removed and attention was turned to the right tube.The essure device was placed in the right tube without difficulty.A final device was opened and placement was again attempted in the left tube.The device again met resistance and the decision was made to end the procedure at this point.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-jul-2019: pfs and mr received : new events, "pregnancy (with complications), abnormal bleeding (vaginal,menorrhagia), psychological or psychiatric problems condition: depression, anxiety and mental anguish, migration of essure device location of device: moved distally in the hydrosalpinx" were added.New reporter contact information was added.Patient's information was added.Patient's demographics were added.Product information was added.Medical history was added.Concomitant medications were added.Lab data was updated.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device: moved distally in the hydrosalpinx') and pregnancy with contraceptive device ('pregnancy (with complications) / pregnancy complicated by ivf pregnancy') in a 30-year-old female patient who had essure (batch no.632032,20222097) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida i, parity 1, hirschsprung's disease, hypertension, irritable bowel syndrome, leg pain, unilateral leg swelling, abdominal pain, ovarian cyst and migraine.Concomitant products included amlodipine besilate (amlodipine besylate), diphenhydramine, docusate sodium, ferrous sulfate (ferrous sulphate), lisinopril, paracetamol (acetaminophen), phenazopyridine, rivaroxaban (xarelto), spironolactone, valaciclovir hydrochloride (valtrex), warfarin, warfarin sodium (coumadin), zolpidem and zolpidem tartrate (ambien).On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced pelvic pain ("physical pain"), 9 days after insertion of essure.On (b)(6) 2010, the patient experienced device dislocation (seriousness criterion medically significant).On an unknown date, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition: anxiety and mental anguish").At the time of the report, the device dislocation, pregnancy with contraceptive device, pelvic pain, vaginal haemorrhage, menorrhagia, depression and anxiety outcome was unknown.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.The reporter considered anxiety, depression, device dislocation, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: essure insertion (b)(6) 2009 : the right tube was identified.The left tube identified and the essure device placed.The device did not release.A second device was then attempted.It was threaded successfully into the tubal ostia and placed.The distal tube could not be identified, but upon inspection, the device had been released from the inserter and was not in the uterus.The ball tip was not present as the device was removed from the tubal ostia, confirming intratubal placement.Essure insertion (b)(6) 2010 : the ostia were visualized and the essure device was placed into the left tube without difficulty.A second device was attempted in that left tube and the tip was noted to bend.This was removed and attention was turned to the right tube.The essure device was placed in the right tube without difficulty.A final device was opened and placement was again attempted in the left tube.The device again met resistance and the decision was made to end the procedure at this point.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion.Lot number: 20222097 manufacture date: 2009-10 expiration date: 2012-10.Lot number: 632032 manufacture date: 2009-09 expiration date: 2012-09.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 19-jul-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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device: moved distally in the hydrosalpinx') and pregnancy with contraceptive device ('pregnancy (with complications) / pregnancy complicated by ivf pregnancy') in a 30-year-old female patient who had essure (batch no.632032,20222097) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida i, parity 1, hirschsprung's disease, hypertension, irritable bowel syndrome, leg pain, unilateral leg swelling, abdominal pain, ovarian cyst and migraine.Concomitant products included amlodipine besilate (amlodipine besylate), diphenhydramine, docusate sodium, ferrous sulfate (ferrous sulphate), lisinopril, paracetamol (acetaminophen), phenazopyridine, rivaroxaban (xarelto), spironolactone, valaciclovir hydrochloride (valtrex), warfarin, warfarin sodium (coumadin), zolpidem and zolpidem tartrate (ambien).On (b)(6)2009, the patient had essure inserted.On (b)(6)2009, the patient experienced pelvic pain ("physical pain/pelvic pain"), 9 days after insertion of essure.In (b)(6)2009, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: anxiety and mental anguish") and abdominal pain ("abdominal pain").On (b)(6)2010, the patient experienced device dislocation (seriousness criterion medically significant).On an unknown date, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and underwent caesarean section ("c-section").The patient was treated with lorazepam and nsaids.At the time of the report, the device dislocation, pregnancy with contraceptive device, pelvic pain, vaginal haemorrhage, menorrhagia, depression, anxiety, abdominal pain and caesarean section outcome was unknown.Pregnancy related information: prospective report.The patient's obstetric status was gravida 1, para 1.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, anxiety, caesarean section, depression, device dislocation, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: essure insertion (b)(6)2009 : the right tube was identified.The left tube identified and the essure device placed.The device did not release.A second device was then attempted.It was threaded successfully into the tubal ostia and placed.The distal tube could not be identified, but upon inspection, the device had been released from the inserter and was not in the uterus.The ball tip was not present as the device was removed from the tubal ostia, confirming intratubal placement.Essure insertion (b)(6)2010 : the ostia were visualized and the essure device was placed into the left tube without difficulty.A second device was attempted in that left tube and the tip was noted to bend.This was removed and attention was turned to the right tube.The essure device was placed in the right tube without difficulty.A final device was opened and placement was again attempted in the left tube.The device again met resistance and the decision was made to end the procedure at this point.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6)2009: total bilateral occlusion; on (b)(6)2009: unilateral occlusion cleft tube occluded; on (b)(6)2010: unilateral occlusion (right tube occluded),; on (b)(6)2012: total bilateral occlusion.Lot number: 20222097 manufacture date: 2009-10 expiration date: 2012-10.Lot number: 632032 manufacture date: 2009-09 expiration date: 2012-09.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-nov-2019: pfs received- pregnancy outcome updated to live birth; outcome unknown.New events abdominal pain, c-section were added.New reporter, treatment drug were 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.
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