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Event related to regulatory report: 2029214-2023-01068.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Rémi rolland, antoine loubet, sébastien bommart, valérie monnin-bares, hamid zarqane, juliette vanoverschelde, fanchon herman, nicolas molinari, and hélène kovacsik; journal of clinical medicine; 2023; 12, 3385.; safety, efficacy and mid-term outcome for transarterial embolization (tae) of renal angiomyolipoma (aml) using ethylene vinyl alcohol copolymer liquid embolic agent (evoh); doi.Org/10.3390/jcm12103385.Medtronic received information in a literature article of pateints treated with onyx and echelon catheter's having complications.The purpose of the article was to report the experience using ethylene vinyl alcohol copolymer liquid embolic agent (evoh) with a single-center retrospective study of all angiomyolipoma (aml) embolized with evoh between june 2013 and march 2022.A total of 29 embolizations were carried out in 24 consecutive patients (mean age: 53.86 years; 21 women and 3 men) with 25 amls for severe bleeding, symptomatic aml, tumor size > 4 cm, or presence of aneurysm(s) > 5 mm. four patients (16%) underwent emergency embolization for active bleeding after stabilization, including one hypovolemic shock.The remaining were embolized electively (n = 13 patients, 52%), in which eight patients (32%) had symptoms associated with their aml: two patients had isolated hematuria, four patients had isolated flank pain, and two patients had both.Procedure: all tae procedures were performed by four experienced interventional radiologists who were familiar with the procedure.Three patients had previous embolization with micro-particles and/or micro-coils.These patients were previously embolized in centers that did not use evoh or radiologists in our center who were not familiar with the use of onyx. the right or left common femoral artery was punctured under ultrasound imaging, and a 6-french (fr) sheath was introduced by seldinger technique.An aortogram was obtained first through a 6-fr guiding sheath to locate the renal arteries and to identify any accessory renal arteries or extra-renal feeding arteries.Selective renal angiography was then performed to assess the vascularization of the aml, extension of tumor vessels outside the normal nephrogram, and vessel displacements by the tumor, as well as to identify aneurysms.In patients with severe bleeding, active extravasation, and retroperitoneal blood were identified.Then, superselective catheterization of the aml feeding vessels was achieved to spare as much renal parenchyma as possible, using a coaxial 2.0 microcatheter with dual marker bands (echelon), as well as an onyx-compatible microcatheter.The dead space of the microcatheter was meticulously flushed with dimethyl sulfoxide (dmso) solvent to avoid early polymerization of the onyx in the lumen of the catheter.Onyx (6% or 8% evoh) was injected at a steady rate of 0.16 ml/min firstly, whilst the dead space was being filled, to avoid development of vasospasm due to dmso.The evoh concentration (6% or 8%) was arbitrarily chosen based on our experience with tumor devascularization, considering that the lower the concentration of the copolymer, the less viscous the agent is, allowing a more distal embolization.A total of 6% evoh was preferably used (88% of aml).If check angiography identified other feeding vessels, further superselective catheterization and embolization were performed.The injection was continued and repeated until the distal end of the feeding arteries of the aml and their dysplastic portions were completely occluded.The endpoint of the procedure was complete devascularization of the tumor, except when small branches cannot be catheterized (vessel diameter under 1 mm), which was specific to the individual vascular anatomy and clinical situation.Postembolization angiography performed through the 6-f catheter confirmed successful occlusion of the artery and the patency of other renal arteries branches.Technical success was defined as no opacification of the main feeding arteries and lack of aml staining on the post-tae angiography after one embolization (primary technical success) or two (secondary technical success). after completion of the injection, the microcatheter was removed by pulling gently during slight aspiration.Results: the therapeutic indication for onyx embolization was based on size in 92% of cases (n = 23 patients), on symptomatology in 32% of patients (n = 8 patients), on bleeding in 16% of them (n = 4 patients), andin 20% of patients on the presence of an aneurysm (n = 5 patients).The mean post-embolization volume was 93.4 (±253.1) cm3 , with a mean volume reduction of 107.7 cm3 (±267.3) per lesion or 53.6% (±28.3%).We had a total technical success of 96% with a primary technical success of 88% after only one embolization (23 amls) and a secondary technical success of 92% after two embolization (2 amls).Two patients had a scheduled embolization in two times because of the multitude of vascular pedicles, in order to limit the duration of the procedure.Two other patients presented a partial revascularization of their aml after 274 days and 547 days respectively, by new vascular pedicles after a first successful embolization.Their second embolizations were complete without recurrence.A total of four amls had two embolizations.Three pa tients had been embolized with other embolization agents before onyx.One patient, with tuberous sclerosis complex, had three previous embolization with microparticles (700 and 900 microns) and supplemental coil occlusion before embolization with onyx.One other p atient had a previous embolization with 900-micron microparticles.Finally, another patient had been embolized with two micro-coils in another center.Minor complications were recorded in three patients (12%) and major complications in two patients (8%).One patient had a non-targeted embolization of the renal parenchyma during embolization (minor complication).The onyx was not correctly visible (on poor homoge nization with tantalum powder).The non-target embolization represented 28% of renal parenchyma, with no alteration of renal function at follow-up.One other patient had a pseudoaneurysm of the punctured femoral artery resulting in an additional day of hospitaliza tion (minor complication).Doppler follow-up showed the resolution of the latter after being successfully treated by ultrasound-guided compression and monitoring.One patient had a post-embolization syndrome (pes) 48 h after embolization, with further anti-inflammatory and analgesic treatment (minor complication).One patient had a renal artery dissection during embolization, ultimately leading to non-target embolization of 20% of the kidney (major complication).The patient then had a pulmonary embolism and the appearance of a bilateral pleural effusion.She presented with hypovolemic shock due to a massive retroperitoneal rupture of the tumor.She also developed healthcare-associated pyelonephritis (major complication).One other patient presented, 15 days after embolization, a superinfection of the embolization site with fistulization in the pyelocaliceal system, leading to lipuria.The patient was hospitalized with antibiotics and analgesics (major complication).The aml drained itself almost completely into the pyelocaliceal cavities, conducting a volume shrinkage of 99%.
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