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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During procedure, physician used venaseal occluding device to treat 34cm length of the right great saphenous vein (gsv).Local anesthesia was used.Transducer was used for compression.The lumen was flushed prior to use.Ifu was followed.A guidewire was used for the insertion of the catheter.Skin irritation was present.Patient symptoms or complications associated with this event is hypersensitivity reaction.It was reported that within first week of procedure, patient developed intense itching and redness in the right medial thigh that extended to the groin.Patient also had trailing thrombus noted 4.1mm into common femoral vein.Branch off gsv with superficial thrombus extending mid to distal thigh.Patient applied topical steroids with no improvement and started methylprednisolone 4mg therapy pack.Allegra and claritin recommended and started xarelto 15mg bid for 2 weeks for thrombus.No further injury reported.
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