During the index procedure two inpact av access balloon catheters were used to treat the left cephalic arch.During a revascularisation, two medtronic pta were used to treat the cephalic arch.Two medtronic pta were also used to treat the cephalic arch during another revascularisation.Approximately six months post index procedure the patient suffered thrombosed left cephalic fistula.The patient was treated with medication.The investigator assessed the event as unlikely to be related to the index device, procedure or paclitaxel.Safety assessed the event as not related to the index device, procedure or paclitaxel.
|
Patient is a former smoker, with a medical history of diabetes, hypertension, renal insufficiency and previous pta in the cephalic arch and venous outflow.It was reported that the four devices used during revascularization were non-medtronic devices.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.
|