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Lot Number 64421 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 12/17/2021 |
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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Patient underwent venaseal treatment of the left great saphenous vein (gsv).Four days post procedure, follow-up ultrasound demonstrates thrombus/glue in left common femoral vein (cfv).The patient was prescribed xarelto and scheduled for a follow-up ultrasound of the left lower extremity (lle) 2 weeks later.The physician has reported that it is not entirely certain whether it represents glue and/or thrombus.The patient has denied left leg swelling, denies redness or leg feeling hot.The patient has reported a feeling of mild discomfort in left inner thigh but would not consider it pain.The patient has reported a feeling of tiredness in the left leg in the evening.The patient has been taking the prescribed xarelto and will return for the follow-up scan.The patient was advised to contact the physician or go to the emergency department (ed) if symptoms of dvt or shortness of breath are experienced.The patient returned for the 2 week follow-up ultrasound which showed no change in the glue/thrombus in the cfv.The physician suspects if there was a clot present in the cfv that it should have shown some regression after patient took anticoagulants for a dew weeks.No further injury reported.
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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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Patient underwent venaseal treatment of the left great saphenous vein (gsv).Four days post procedure, follow-up ultrasound demonstrates thrombus/glue in left common femoral vein (cfv).The patient was prescribed xarelto and scheduled for a follow-up ultrasound of the left lower extremity (lle) 2 weeks later.The physician has reported that it is not entirely certain whether it represents glue and/or thrombus.The patient has denied left leg swelling, denies redness or leg feeling hot.The patient has reported a feeling of mild discomfort in left inner thigh but would not consider it pain.The patient has reported a feeling of tiredness in the left leg in the evening.The patient has been taking the prescribed xarelto and will return for the follow-up scan.The patient was advised to contact the physician or go to the emergency department (ed) if symptoms of dvt or shortness of breath are experienced.The patient returned for the 2 week follow-up ultrasound which showed no change in the glue/thrombus in the cfv.The physician suspects if there was a clot present in the cfv that it should have shown some regression after patient took anticoagulants for a dew weeks.No further injury reported.
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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.
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Manufacturer Narrative
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Patient is asymptomatic of adverse events.Ifu was followed.No challenged related to location of catheter tip prior to initial delivery of adhesive.Catheter tip 5cm caudal to sfj.Compression of gsv.Glue/thrombus in the deep vein.Glue/thrombus extended from the sfj.Patient is on xarelto, asymptomatic and no further intervention 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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