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Model Number VS-402 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Foreign Body Reaction (1868); Unspecified Infection (1930); No Consequences Or Impact To Patient (2199)
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Event Date 08/01/2019 |
Event Type
malfunction
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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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Physician used venaseal to treat patient.The procedure was completed according to standard protocol and the distal tip was placed 5cm distal to the sapheno-femoral junction prior to administration of adhesive.The procedure was completed without issue.The patient returned to another physician approximately 2 years and 8 months post procedure and reported symptoms unchanged prior to venaseal treatment including ceap iii in lle with pain/heaviness/visible varicose veins.Ultrasound performed demonstrated a 100% patent andrefluxing gsv (no polymer or scarring in the vessel anywhere) but large amounts of polymer in saphenous tributary varicose veins.These tributary varicose veins were hard to palpation, consistent with polymer occlusion.The physician reports incorrect placement or migration of the product during the initial procedure.The patient stated they had asked during initial follow-up during following venaseal implant when the veins would become softer and/or disappear and he would have some relief and informed by the treating physician that they would slowly absorb over several months.The physician plans to treat the original refluxing gsv and possibly extract the glue in tributaries.No additional treatment has been given to the patient.The patient is currently doing well and undergoing a new diagnostic ultrasound.
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Manufacturer Narrative
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Additional information: the venaseal adhesive will not be explanted from the patient.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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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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Physician used venaseal to treat patient.The procedure was completed according to standard protocol and the distal tip was placed 5cm distal to the sapheno-femoral junction prior to administration of adhesive.The procedure was completed without issue.The patient returned to another physician approximately 2 years and 8 months post procedure and reported symptoms unchanged prior to venaseal treatment including ceap iii in lle with pain/heaviness/visible varicose veins.Ultrasound performed demonstrated a 100% patent andrefluxing gsv (no polymer or scarring in the vessel anywhere) but large amounts of polymer in saphenous tributary varicose veins.These tributary varicose veins were hard to palpation, consistent with polymer occlusion.The physician reports incorrect placement or migration of the product during the initial procedure.The patient stated they had asked during initial follow-up during following venaseal implant when the veins would become softer and/or disappear and he would have some relief and informed by the treating physician that they would slowly absorb over several months.The physician plans to treat the original refluxing gsv and possibly extract the glue in tributaries.No additional treatment has been given to the patient.The patient is currently doing well and undergoing a new diagnostic ultrasound.
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Search Alerts/Recalls
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