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See attachments for literature 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.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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On 2024-feb-08 lit (hcp, for, lit): gaute kjellevold wathle, nicola logallo, svein harald mørkve; world neurosurgery; 2023; 178: e323-e330; endovascular treatment of dural arteriovenous fistulas in a medium-sized scandinavian neurovascular center; doi.Org/10.1016/j.Wneu.2023.07.061 medtronic received information in a literature article that patients potentially treated with an apollo catheter and or onyx embolization had complications.The purpose of the article was to perform a retrospective analysis of dural arteriovenous fistulas (davfs) treated at the study hospital to determine if high-quality endovascular treatment can be provided in a medium-volume vascular center.From 2007 to 2021, 69 davf treatments were undertaken in the hospital.Of these davfs, 55 were endovascular, 11 were open surgical procedures, and 3 were gamma knife treatments.Of the endovascular treatments, 10 (18.2%) were in ruptured davfs.The most common location of endovascularly treated davfs was at the transverse/sigmoid sinus (32.7%) and at the cavernous sinus (25.5%).Of the endovascularly treated davfs, 38.2% were low-grade fistulas, whereas 61.8% were high-grade fistulas.58.2% of fistulas were treated transarterially.Davfs located in the cavernous sinus were treated using coils alone, whereas most other davfs were treated with liquid embolics alone or in combination with coils.The average age of treated patients was 61 years and 26 (56.8%) of the patients were men.Procedure: endovascular treatment was performed in most cases either transarterially or transvenously, but in some cases, also as a combined transarterial and transvenous treatment or a hybrid treatment.All endovascular treatments were performed under general anesthesia and with weight-adjusted heparin administration.In most transarterial cases, a triaxial approach was used with a long sheath in either the common carotid or subclavian artery or axs infinity 6f, an intermediate catheter or sofia 5f/6f, and a dmso-compatible microcatheter/balloon catheter (apollo, excelsior sl-10, or headwayduo, scepter c/ scepter mini).For distal navigation, a variety of microwires were used (traxess mini and traxess14; asahi chikai 0.010 and 0.008; synchro2).Hybrid operations with transvenous access through craniotomies were performed with microcatheters (excelsior sl-10 or headwayduo/headway17) through a 4f introducer placed directly into a venous sinus.The choice of embolic agent depended on fistula localization and treatment approach.Liquid embolics (squid; onyx [medtronic]; phil) were used for most transarterial treatments either alone or in combination with coils, except in the cavernous sinus and the foramen magnum, where coils were used alone.Liquid embolics (phil were only occasionally used during transvenous treatments and then always in combination with coils.When they started to perform treatments with liquid embolics, they mainly used phil (25% and low viscosity) because of the ease of use.They then gradually started using more squid because of its better (as they perceive) flow properties and available range of sizes and density (18 and 12, normal and low density).They generally prefer squid (or onyx) when treating disease covered by, or situated close to, bony structures that can obscure visual control, whereas phil, being less radiopaque, is reserved for diseases closer to the vertex and also used in combination with squid in more advanced cases to separate injections in different vessels.They use squid 12 and phil low viscosity only in combination with balloon catheters (scepter or scepter mini) or when a solid plug is already formed during injection.One patient with a large davf to the cavernous sinus was treated 3 times in 2015.Nine patients received 2 treatments, whereas 34 patients were treated only once.This strategy resulted in an average of 1.25 treatments per patient.Liquid embolics (phil, squid, or onyx) were used alone or in combination with coils in 31 treatments (56.3%), whereas coils alone were used in 21 (38.2%).Two treatments (3.6%) were hybrid endovascular treatments (transvenous treatment with coils or coils and glue through a craniotomy), whereas 1 patient was treated in 2007 with transarterial coils and particles.The choice of embolization material depended on the fistula location.Results: of 55 treatments, 41 (74.5%) resulted in complete or near complete cure and another 10 (18.2%) were downgraded to a low-grade fistula.When calculating cure per patient (including retreatments), 38 of 44 patients with davfs (86.4%) were completely or nearlycompletely cured and another 5 (11.4%) had their fistulas downgraded.No patients treated for davfs at the institution have bled or rebled after their treatments.Of 55 treatments, 40 (72.7%) were performed without any remnant or recurrence.In 11 treatments (20.0%), a remnant was left at the time of treatment because attempted total occlusion was deemed to carry a high risk of complications.Eight of these (14.5%) remnant fistulas were aggressive and retreated, whereas 3 (5.5%) were small and benign and were not retreated.The treated fistula recurred in 7 cases (12.7%), all of which were retreated.In total, 15 (27.3%) retreatments were performed, and 12 of these were endovascular.In 55 endovascular or hybrid endovascular davf treatments performed at our institution, there were no procedure-related deaths.Fifty-four treatments (98.2%) were performed without causing permanent neurologic deficit or sequelae and 47 treatments (85.5%) were performed without any kind of complication.One patient (1.8%) experienced a limited medullary infarction as a result of unintended spreading of embolic material and perforator occlusion, resulting in hemiparesis and neuropathic pain.Seven other complications (12.7%) were recorded, all of which were asymptomatic or resulted in only temporary loss of function, which was completely normalized within 6-8 months after treatment.Two patients (3.6%) with complex davfs (1 tentorial and 1 torcular davf) experienced intracranial hemorrhage perioperative.One of these davfs was evacuated through a mini-craniotomy and the other one resorbed spontaneously.Neither of these patients experienced permanent neurologic sequelae.Two patients (3.6%) experienced thromboembolic complications.One patient experienced a medullary infarction and 1 patient with an extensive subarachnoid hemorrhage from a ruptured flow-induced arterial aneurysm in the posterior fossa to a tentorial davf experienced hypoperfusion infarctions in the opposite side of the cerebellum, most likely related to vasospasm from the subarachnoid hemorrhage rather than to the fistula treatment itself.Two patients (3.6%) experienced smaller areas with skin necrosis that healed without surgical treatment within 6-8 weeks.One of these patients also experienced a peripheral facial palsy, most likely caused by unintended spreading of liquid embolic material to the vasa nervorum in the facial canal.The facial palsy resolved completely in 8 months.Two other complications occurred.One patient with a ruptured davf at the foramen magnum treated with coils alone experienced temporary cortical blindness, which resolved completely after 2 days.On e patient treated with a hybrid endovascular procedure in which a craniotomy was placed over the transverse sinus postoperatively developed a fluid collection under the bone flap.She experienced temporary mild dysarthria before the fluid collection resolved spont aneously and her symptoms resolved completely after a few days.
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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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