Product analysis: the protégé everflex peripheral stent delivery system was returned for evaluation.No ancillary devices, cine, images or procedures were returned for evaluation.The returned device show a portion of the stent was detached distally.The remaining stent remained on the catheter.The device was returned with the stent exposed and stretched.A portion of the stent was detached.Approximately 60mm of the stent was detached proximal from the distal tip.Dried biological residue was observed within the outer sheath.The outer sheath was cut to remove the remaining stent.The remaining portion of the stent was measured to approximately 90mm to the proximal marker hoop.Approximately 60mm of the stent and distal marker hoop is missing.Visual inspection of the retainer under magnification show no abnormality.Multiple kinks were observed on the catheter outer sheath.There is evidence of gouge in the outer sheath that appears to run distal to proximal of the catheter.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.
|