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| Model Number ESS305 |
| Device Problem
Material Protrusion/Extrusion (2979)
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| Patient Problems
Anemia (1706); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Perforation (2001); Sleep Dysfunction (2517)
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Event Type
Injury
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Event Description
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This case report from united states was derived from medical literature on 04-aug-2016, article entitled "combined hysteroscopy-laparoscopy approach for excision of pelvic nitinol fragment from essure contraceptive device: role of intraoperative fluoroscopy for uterine conservation" from obstet gynecol sci vol 59, pages 337-341; year 2016.The author sills es; palermo gd refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2011.A (b)(6) non-smoking (b)(6) presented for evaluation of chronic pelvic pain first noted following hs (hysteroscopic sterilization) in (b)(6) 2011.The essure procedure was completed under ketorolac intravenous sedation in an ambulatory surgery center setting.Three months later, the patient was informed that bilateral tubal occlusion was confirmed by hysterosalpingogram, but a detailed review of findings was not provided.Soon after hs, the patient reported increased, irregular vaginal bleeding and dyspareunia.Within 4 to 6 weeks of her essure procedure, the patient developed intermittent right lower quadrant pain, headaches, insomnia, lower extremity paresthesia, intolerance to cold, and fatigue.Although the patient was in excellent general health before hs and only visited the doctor for annual check-ups, following the essure procedure, she had approximately 36 clinic appointments (partial year).No specific diagnosis or treatment was offered.Her symptoms persisted during subsequent years and insurance records showed a sharp uptick in frequency of health visits following the essure procedure: 34 billed encounters in 2012 to discuss pelvic pain issues with various healthcare providers, 22 consultations in 2013, 28 visits in 2014, and 54 appointments in 2015 (partial year).In addition to consultations, these visits included multiple in-office ultrasounds, three computed tomography scans, and blood tests with no abnormal findings identified from these evaluations.The patient obtained a flat panel abdominal x-ray (anterior posterior view) in (b)(6) 2015 and this study showed the left essure implant located within the corresponding fallopian tube, although the right device was in two asymmetric parts.In (b)(6) 2015, the patient had a follow-up hysterosalpingogram which showed a normal endometrial cavity and bilateral tubal occlusion.Consistent with the confirmatory hysterosalpingogram performed after hs, the right essure device appeared disrupted with a small portion possibly corresponding to the medial terminal marker near the right cornu, but the majority of the implant was situated at the lateral pelvis.In (b)(6) 2015, the patient underwent diagnostic hysteroscopy and 5-mm triple-port laparoscopy with partial bilateral salpingectomy for removal of essure implants.The intrauterine compartment appeared grossly normal and both tubal ostia were visualized.At laparoscopy, both ovaries were normal appearing and the outer coil of the right essure device could be seen protruding from tubal serosa lateral to the right uterotubal junction.This was removed without difficulty using bipolar cautery and circumferential dissection, as previously described.However, a component of the right essure device was fluoroscopically identified laterally and cephalad to the uterine fundus, although the fragment could not be seen during laparoscopy.The left implant was entirely contained within tubal tissue and was removed using the same technique, with the left implant closely inspected during laparoscopy to verify presence of all terminal markers.It was noted that the inner rod's terminal (medial) marker was absent.Intraoperative fluoroscopy was performed and this permitted retrieval of the device remnant.Postoperative computed tomography was performed which showed the left cornual region was free of any foreign body, but the right essure fragment was lodged near intestinal serosa at the proximal colon.Because the procedure ended in the late afternoon, the patient stayed overnight and was discharged home from the outpatient surgery floor the following morning.Her postoperative course has been uncomplicated and she continues to do well.Company causality comment: this medically confirmed, case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and within 4 to 6 weeks after essure insertion she experienced intermittent right lower quadrant pain/ chronic pelvic pain.About 4 years and 2 months after insertion, a follow-up hysterosalpingogram was performed which result showed right essure device appeared disrupted/ right device was in two asymmetric parts (interpreted as device breakage).About 4 years and 4 months after insertion, a diagnostic hysteroscopy and 5-mm triple-port laparoscopy with partial bilateral salpingectomy for removal of essure implants were performed.At laparoscopy, it was reported that right essure device could be seen protruding from tubal serosa lateral to the right uterotubal junction (seen as fallopian tube perforation).These events are listed in the reference safety information for essure.Pelvic pain, device breakage and fallopian tube perforation may occur with essure therapy.In this case, the events occurred after essure insertion.However the exact date and mechanism for device breakage and fallopian tube perforation were not known.Based on the nature of the events and considering a compatible temporal relationship, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident since surgical intervention was performed.Additionally, non-serious events were reported.Follow-up information and product technical analysis are being sought.
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Manufacturer Narrative
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Perforation and device breakage questionnaire received on 31-aug-2016 the consumer's initial was updated.Her weight was (b)(6) and height (b)(6).Her medical history included gravida 4, 2 parities, 2 ectopic pregnancies and one c-section.Previous gynecological intervention was denied.Essure was inserted in (b)(6) 2011 not after a c-section.She was not breastfeeding at time of procedure.During insertion, analgesia (i.V.Ketorolac) was used.Immediately after insertion, she complained of sharp pelvic pain (worse in right side).Based on this result, she was advised to rely on essure.Three months after insertion, hsg (hysterosalpingogram) was done and confirmed tubal occlusion.In (b)(6) 2015, x-ray and hsg were done and left essure was in correct position.Device on right side had fragmented (implant broke); device appeared to have fragmented at the junction of medial/proximal terminal marker after remaining in situ for years.It had migrated to omentum and bowel.She presented with abdominal pain, dyspareunia, dysmenorrhea, headache, fatigue and lower extremity paresthesia.On (b)(6) 2015, essure was removed by hysteroscopic/laparoscopic because it was medically necessary and because patient requested.Broken pieces were retrieved from fallopian tubes and abdomen/pelvis.Pathology result showed diffuse salpingitis.Two surgeries were required to remove of laterally migrated right coil which was not in tube (procedural also included adhesiolysis).Outcome was reported as recovering and recovered with sequelae.Company causality comment: this medically confirmed, case report derived from medical literature, article entitled "combined hysteroscopy-laparoscopy approach for excision of pelvic nitinol fragment from essure contraceptive device: role of intraoperative fluoroscopy for uterine conservation", refers to a female patient who had essure (fallopian tube occlusion insert) inserted and within 4 to 6 weeks after essure insertion she experienced intermittent right lower quadrant pain/ chronic pelvic pain.About 3 years and 10 months after insertion, a follow-up hysterosalpingogram was performed which result showed right essure device appeared disrupted/ right device was in two asymmetric parts, device appeared to have fragmented at the junction of medial/proximal terminal marker after remaining in situ for years (interpreted as device breakage) and it had migrated to omentum and bowel.A diagnostic hysteroscopy and 5-mm triple-port laparoscopy with partial bilateral salpingectomy for removal of essure implants were performed.At laparoscopy, it was reported that right essure device could be seen protuding from tubal serosa lateral to the right uterutubal junction (seen as fallopian tube perforation).These events are listed in the reference safety information for essure.Pelvic pain, device breakage and fallopian tube perforation may occur with essure therapy.In this case, the events occurred after essure insertion.However the exact date and mechanism for device breakage and fallopian tube perforation were not known.Based on the nature of the events and considering a compatible temporal relationship, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident since surgical intervention was performed.Additionally, non-serious events were reported.A product technical analysis is being sought.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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Quality-safety evaluation of ptc: (b)(4).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.The possibility micro-insert is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.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 event cannot be totally excluded.However, the medical event is a known, possible, undesirable event 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 26-jan-2017: quality-safety evaluation of ptc received.Company causality comment: this medically confirmed, case report derived from medical literature, article entitled "combined hysteroscopy-laparoscopy approach for excision of pelvic nitinol fragment from essure contraceptive device: role of intraoperative fluoroscopy for uterine conservation", refers to a female patient who had essure (fallopian tube occlusion insert) inserted and within 4 to 6 weeks after essure insertion she experienced intermittent right lower quadrant pain/ chronic pelvic pain.About 3 years and 10 months after insertion, a follow-up hysterosalpingogram was performed which result showed right essure device appeared disrupted/ right device was in two asymmetric parts, device appeared to have fragmented at the junction of medial/proximal terminal marker after remaining in situ for years (interpreted as device breakage) and it had migrated to omentum and bowel.A diagnostic hysteroscopy and 5-mm triple-port laparoscopy with partial bilateral salpingectomy for removal of essure implants were performed.At laparoscopy, it was reported that right essure device could be seen protruding from tubal serosa lateral to the right uterutubal junction (seen as fallopian tube perforation).These events are anticipated according to the reference safety information for essure.Device breakage was considered anticipated upon receipt of the product technical analysis.In this case, the events occurred after essure insertion.However the exact date and mechanism for device breakage and fallopian tube perforation were not known.Based on the nature of the events, a causal relationship with essure cannot be excluded.This case was regarded as incident because surgical intervention was performed and device removal was required.Additionally, non-serious events were reported.According to the product technical analysis, product quality defect could not be confirmed but is considered plausible.No further information is expected.
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