Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the reliant device.The exact size of the device is unknown.Survey results from an interventional cardiologist in practice 20 years, who has used the reliant device for expansion of vascular prostheses 25 times in total of which 22 of those times were in the last 12 months.For temporary occlusion of large vessels it was used 25 times in total of which 12 of those times were in the last 12 months.During use of the reliant for expansion of vascular prostheses (assisting in the expansion of self-expanding stent grafts), the fol lowing complications were encountered; respiratory failure (pulmonary embolism) , entry site hematoma (significant diameter of the catheter (on the french catheter scale, i.E.The diameter of catheters in millimeters.), aneurysm (paraprosthetic endoleak) , emboli (peripheral embolism despite distal protection mechanism), stent graft migration caused by balloon catheter device (migration of the prostheses because of unfavorable anatomy) , kink in the balloon (transfer to a flat surface).The physician found the respiratory failure very concerning and not at all concerning, the entry site haemtoma somewhat concerning and not at all concerning, the aneurysm somewhat concerning, the emboli very concerning, the stent graft migration not at all concerning, the kink in the balloon not at all concerning, all of the adverse events above, none were reported to be related to the device itself.During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; stroke (cerebral embolism) , aneurysm rupture (aneurysm fixing which required a covered stent implant (endoprosthesis) , balloon rupture (rupture because of use of high air pressure).The physician found the stroke events very concerning, the aneurysm rupture very concerning, the balloon rupture very concerning.The balloon rupture event was deemed to be related to the device itself.Of the above complications reported, some of these are listed as having been reported to medtronic previously.Due to limited information these are included in reporting.No further information has or will be provided.
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Update to h2; fdc code added at completion of investigation 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.
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