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Catalog Number VS-402 |
Device Problem
Biocompatibility (2886)
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Patient Problem
Reaction (2414)
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Event Date 07/07/2020 |
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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The physician used a venaseal closure system to close the great saphenous vein.Tumescent infiltration was not utilized.Local anest hesia was used.No compression was used.The lumen was flushed prior to use.The ifu was followed during preparation, procedure, post-procedure.A guidewire was used for the insertion of the catheter.The procedure was completed as normal.There is no alleged product issue.The patient has an evolving allergic reaction to the venaseal implant displaying systemic hives and rash.The patient is on oral steroids and antihistamines.The physician is waiting to explant this vein with the hope that symptoms resolve with steroids and antihistamines.The patient is alive with injury.
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Manufacturer Narrative
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Additional information: the systemic hives and rash were moderate and delayed.The patient is due to return for a follow-up appointment in a few weeks.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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Manufacturer Narrative
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Update sections 2.3 - event date and d.6 - implant date.Additional information: patient was reported to be doing well approximately 1 month after the reported event (b)(6) 2020).The vein has not been explanted.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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