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M.Pérez, h.Henkes, w.Kurre, c.Bleise, p.N.Lylyk, j.Lundquist, f.Turjman, h.Alhazmi, c.Loehr, s.Felber, h.Deutschmann, s.Lowens, l.Delehaye, m.Möhlenbruch, j.Hattingen, and p.Lylyk; journal of clinical medicine; 2022; 11, 884; results of the ptowin study: using the pconus device for the treatment of wide-neck intracranial aneurysms; doi.Org/10.3390/jcm11030884.Medtronic received information in a literature article that patients potently treated with marksman or rebar18 catheters had complications.The article presented the results of the pconus treatment of wide-neck intracranial aneurysms (ptowin) study, a clinical trial of the first generation of the pconus device.The purpose of this study was to evaluate the safety and effectiveness of the pconus as a permanent implant to assist the coil occlusion of wide-neck bifurcation aneurysms (wnbas).Between september 2015 and august 2018, a total of 115 patients (77 (66.9%) females) were enrolled in ten centers across five countries were prospectively enrolled. all aneurysms but one were unruptured (99.1%), and 14 (12.2%) had already been previously treated. the majority of the aneurysms were located at the middle cerebral artery (mca) bifurcation (n = 52), followed by acoma (n = 35) and basilar tip (n = 23). the mean dome width was 6.8mm, the mean dome height was 6.2mm, and the neck width was 4.9mm.A mean dome-to-neck ratio of 1.4 was calculated from these results.In 71.1% of aneurysms, a dome-to-neck ratio 1.5 was observed, and could thus be classified as wide-neck aneurysms. almost all patients received dual antiplatelet treatment (dapt) as recommended. treatment with the pconus device was successfully performed in 114 out of 115 (99.1%) patients.In one (0.9%) patient, the device was implanted and navigated with a second microcatheter to coil the aneurysm sac.The following microcatheters were used during the procedures: excelsior sl-10 or trevo18 pro , prowler select plus or rapid transit , marksman or rebar18, or vasco.Results: the primary effectiveness endpoint was the rate of adequate aneurysm occlusion at the 3¿6- and 7¿12-month angiographic follow-up visits. a total of 60 adverse events were reported during the study in 42 (36.5%) of the 115 patients.Of these 60 events, 33.3% (20/60) were classified as serious (serious adverse events¿sae) and occurred in 18 patients (18/115, 15.7%). one (0.9%) patient died.Twelve (10.4%) patients were hospitalized, or their hospitalization was prolonged.In three (2.6%) patients, a medical or surgical intervention was performed to prevent life-threatening illness or injury/permanent impairment to a body structure or function, and four (3.5%) patients showed permanent impairment of a body structure or function.Six events were observed peri-procedurally.In two (1.9%) patients, the aneurysm was perforated with the pconus device during the intervention, and thromboembolic events were reported in four (3.7%) patients.During the follow-up period, a small sah was found in one patient on day 3 post-intervention, which was classified as procedure-related.Additionally, one rupture of the treated aneurysm was observed within the 3¿6-month follow-up period.On day 203, this patient experienced a subarachnoid hemorrhage the day before a planned retreatment for the aneurysm while being already hospitalized.The aneurysm was retreated as planned the next day.No additional ruptures of the treated aneurysms were observed during the 7¿12-month period.Within 3¿6 months after the intervention, one patient suffered an ischemic stroke, while within the 7¿12-month period, a second ischemic stroke occurred (cumulative incidence 2.3%).Both ischemic strokes were considered to be minor.Additional information received reported that sometimes a microcatheter from medtronic was used, so it was used as an access device.
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Continuation of d10: product id: unk-nv-marksman; product id: unk-nv-rebar; product id: unk-nv-marksman; g2: citation: authors: m.Pérez, h.Henkes, w.Kurre, c.Bleise, p.N.Lylyk, j.Lundquist, f.Turjman, h.Alhazmi, c.Loehr, s.Felber, h.Deutschmann, s.Lowens, l.Delehaye, m.Möhlenbruch, j.Hattingen, and p.Lylyk.Results of the ptowin study: using the pconus device for the treatment of wide-neck intracranial aneurysms.Journal of clinical medicine 11, 884 2022.Doi.Org/10.3390/jcm11030884.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.See manufacturer report#: 2029214-2023-02126 for another report from this article.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.
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