Product analysis:an angiographic image provided shows a balloon has been delivered to the lad and post dilation is performed.There is a previously deployed stent in the lcx, with second support wire present in the lcx.The following two images show contrast exiting the wall of the lad confirming perforation to the vessel.There is diffuse disease throughout the vessel.The following image he deflated balloon inside the distal end of the newly deployed stent.The stent profile does not appear to be fully concentric suggesting that the calcification or fibrotic nature of the lesion was preventing full concentric stent expansion and the inflation of the nc euphora balloon at high pressure against the stent as a result of the difficult lesion morphology resulted in the perforation of the vessel.The final image shows a stent has been delivered inside the body of the previously deployed stent.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.
|