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Catalog Number VS-404 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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Physician used venaseal closure system to treat a segment in the great saphenous vein (gsv).Tumescent infiltration and local anesthesia were used.There was no alleged product issue with venaseal during implantation.Catheter tip was 5cm from sapheno femoral junction.Compression was done on the gsv.The procedure was completed successfully.The vein did close.It was reported that the patient came back for a 3 month follow up visit and pieces of the implanted venaseal adhesive were exuding from patient's leg.Approximately 3 months post procedure, patient was seen and treated for the condition.Patient to follow up in a month to evaluate the condition.No further patient injury reported.
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Manufacturer Narrative
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Date of event: event date, month and year valid.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Update received 24th feb 2022.
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Manufacturer Narrative
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Additional information: there is not a specific plan going forward.The patient hasn't been back yet and no new medication has been prescribed per the provider.The patient is on his own and will check in with the provider only as needed.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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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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