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Model Number UNK-NV-AXIUM |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Muscle Weakness (1967); Paresis (1998)
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Event Date 05/15/2019 |
Event Type
malfunction
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Event Description
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Alqaim m, puri as, vaezi ae, schanzer a.Carotid body tumor resection utilizing a covered stent graft to enable resection of the tumor en bloc with the internal carotid artery. journal of vascular surgery cases and innovative techniques.2019;5(4):481-484.Doi:10.1016/j.Jvscit.2019.07.012 medtronic literature review found a report of right upper extremity parathesis and right upper extremity weakness during balloon occlusion testing for a carotid body tumor and mild postoperative dysphagia and minimal blood loss in association with a coil embolization and a stent graft placement for a carotid body tumor resection in the left internal carotid artery.The surgery occurred in two phases.The first phase being balloon testing and coil embolization of the blood vessels feeding the tumor.The second phase was stent graft placement and resection of the tumor.The purpose of thisarticle was to explain the surgical treatment of a carotid body tumor utilizing a covered stent graft.The authors reviewed one case of a patient treated for a carotid body tumor using a covered stent graft.To enable resection of the tumor.The patient was a 30 year old male with a past medical history of seizure disorders.The article does not state any technical issues during use of the axium coils.The following intra- or post-procedural outcomes were noted: successful stent placement to serve as a bridge to preserve blood flow while the tumor was resected during balloon occlusion testing, right upper extremity parathesis and weakness occurred post-operatively, minimal blood loss with mild postoperative dysphagia the patient discharged on day 3 tolerating a regular diet.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Attached is the 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.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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Manufacturer Narrative
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H6.Device coding fdd/annex a corrected based on an effectiveness check/file review.No new information received.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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Search Alerts/Recalls
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