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Model Number UNK-NV-MARATHON |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intracranial Hemorrhage (1891); Nerve Damage (1979); Pain (1994); Respiratory Insufficiency (4462)
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Event Date 08/13/2022 |
Event Type
Injury
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Event Description
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Su x, fan x, ma y, wang j, wang y, zhang h.Diagnosis and treatment of a dural arteriovenous fistula involving the superior petrosal vein.World neurosurgery.2022;167:e648-e655.Doi:10.1016/j.Wneu.2022.08.065 medtronic literature review found a report of patient complications in association with onyx liquid embolic and marathon catheter.The purpose of this article was to discuss and analyze the features of a superior petrosal vein dural arteriovenous fistula (spv davf).Thirty patients with spv davfs were retrospectively included in the study.Of the 30 patients, 24 were male and the average age of the 47.5 years.Patients were treated with onyx and marathon devices during embolization.Twenty-one were treated with embolization alone, 8 were treated with microsurgery alone, and one patient was treated with both embolization and microsurgery.The imaging results of the patients after treatment all revealed complete obliteration of the fistula, and no fistula recurrence.The article does not state any technical issues during use of the onyx or marathon.The following intra- or post-procedural outcomes were noted: - one patient died due to excessive postoperative bleeding.Intraoperative angiography had revealed complete obliteration of the fis tula. - two total patients experienced intracranial hemorrhage. - two patients experienced cranial nerve palsy. - two patients had peripheral facial palsy after middle meningeal artery (mma) embolization but recovered completely after 3 months. - one patient with dyspnea 2 days after surgery was treated with invasive mechanical ventilation. - the symptoms of trigeminal neuralgia on the right side improved after embolization in 1 patient.However, their symptoms recurred 2 years after treatment.No fistula recurrence was found during the reexamination, so they underwent microvascular decompression and rhizotomy of the trigeminal nerve. - one patient underwent microsurgery who had difficulty embolizing/ was unable to achieve curative embolization.The patient did not experience neurological deterioration. - a second embolization was performed on 2 patients to obliterate remaining fistula.
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Manufacturer Narrative
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Concomitant medical products: product id unk-nv-onyx; product type: ; implant date ; explant date product id unk-nv-marathon; product type: ; implant date ; explant date product id unk-nv-onyx; product type: ; implant date ; explant date g2: citation: authors: su, x., fan, x., ma, y., wang, j., wang, y., <(>&<)> zhang, h.Diagnosis and treatment of a dural arteriovenous fistula involving the superior petrosal vein.World neurosurgery 167:e648-e655 2022.Doi:10.1016/j.Wneu.2022.08.065 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 # 2029214-2023-01128, 2029214-2023-01129, and 2029214-2023-01130 for other reports 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.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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