A physician was attempting to implant a protege rx self-expanding stent for the treatment of a plaque lesion with 80% stenosis in the mid common carotid artery. there was moderate tortuosity and calcification.Spider embolic protection device was used.The device was prepped as per the ifu with no issues identified.It was reported the patient had internal carotid artery stenosis, the device was placed.During deployment, the handle was fixed.When the catheter was wthdrawn, the stent could not be deployed.The device was replaced in order to complete the procedure.No difficulties removing.No patient injury reported for this event.When the device was retuned to the facility for evaluation, it was noted that the stent was exposed.
|
Product analysis the device was returned with the 2mm of the stent exposed the stent confirmed as 40mm the touhy borst was observed to have biologics in it the stent could not be deployed, the device was received with the proximal grip fully extended to the y connector and the inner stainless steel was exposed, the strain relief, y connector and touhy borst were all loose on the stainless-steel rod the device was returned with dried biologics observed under the outer sheath no functional testing could be carried out due to the condition of the returned device.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.
|