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Model Number VS-404 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 01/09/2024 |
Event Type
Injury
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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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Event Description
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During a venaseal procedure to treat a patients great saphenous vein (gsv), physician had difficulty locating the tip of the catheter at the sfj.Tumescent infiltration was not utilized.Sales rep asked physician to pull back until catheter could be visualized.Catheter could only be seen around the 12cm mark from the sfj.Physician wanted to treat closer to 5cm and close as much as the vein as possible.Physician continued and moved on with the procedure.According to physician, the ultrasound performed approximately 1 week later showed partial compressibility of the cfv and fv.Physician thinks it might be glue sticking out into the deep system.It is potentially thrombus extension or glue.Physician prescribed eliquis and patient will return to be re-scanned to see if there are any changes to the patency of the cfv and fv.
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Manufacturer Narrative
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Additional information: the patient was seen on (b)(6) 2024, no resolution was found on ultrasound and patient was given xarelto.Physician seen patient again since and the ultrasound scan looked better and patient is no longer taking xarelto.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 image is a single image labeled rtcfv.There appears to be extension of thrombus or glue into the cfv from the gsv.Image is a single image and i am unable to determine what is being depicted from a single image.Image is a single image, which appears to be showing the rt femoral vein with and without compression.It appears to be comp ressible at this level." additional information received reported that xarelto was given to the patient on jan 15th and stopped it on feb 12th.The thrombus resolved.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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