Catalog Number VS-402 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Reaction (2414)
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Event Date 01/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Patient received venaseal treatment of the great saphenous vein (gsv).11 segments were treated, and the vein is reported to have closed.Procedure was completed as per ifu.It is reported the patient reported 9-10 days post implant with redness along the treated vein tract.The physician instructed the patient to use warm compresses and nsaids to treat.It is reported the symptoms continued to get worse with redness spreading to the abdomen and opposite thigh.The treating physician then prescribed a course of steroids to treat the hypersensitivity.At this time symptoms have improved.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: the patient's condition has fully resolved and is doing well with no issues.No further patient injury.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: the left gsv was treated and 1.8cc of venaseal were used to treat the vessel.The hypersensitivity is almost fully resolved.If information is provided in the future, a supplemental report will be issued.
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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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Search Alerts/Recalls
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