Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the right common femoral artery approach was used.The blood vessel was sutured with a percutaneous device at the end of the procedure.The procedure was completed with a partial dissection and thrombus noted in the common femoral artery.Subsequently, a stent was implanted, and the condition of the patient was improved.No additional adverse patient effects were reported.
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Additional information was received that it was unknown when the injury had first occurred.Per the physician, the cause of the blood vessel injury is unknown.However, it was reported that per the physician, the delivery catheter system (dcs), closure device and external introducer sheaths did not contribute.Heparin was administered during the procedure and the patient's act (activated clotting time) levels were monitored every 60 minutes.The total procedure time was two hours.No additional adverse patient effects were reported. updated d - suspect medical device.Updated h.6 - eval method code.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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