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Model Number VS-403 |
Device Problem
Biocompatibility (2886)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the physician venaseal was used to treat 1 segment of the great saphenous vein (gsv).The venaseal procedure was completed as per the ifu and with the immediate closure of the treated gsv.The sfj was scanned with ultrasound and no evidence of deep venous glue was observed at the completion of the procedure.The sfj was again scanned with ultrasound at the routine follow up and a small deposit of glue was observed on the posterior wall of the common femoral vein observed during the routine follow up, ultrasound duplex.No additional treatment was required.No patient injury reported for this event.
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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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Image review: the image is labeled rt in one location, and cfv prox in another.This would seem to align with the reported history of treatment of a gsv.Apparently this is on the right leg.This is a color flow image, which depicts flow in the cfv which is blue.The lower right corner, at approximately 3-5 o¿clock on the dial suggests intraluminal material with lack of color flow filling.From the image itself, it would be hard to conclude if this is thrombus or glue.It is a minimal filling defect on color flow without hemodynamic significance as showing in this one frame of information.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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