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 14 years, who has used the reliant device for expansion of vascular prostheses (assisting in the expansion of self-expanding stent grafts) 67 times in total, of which 51 times were in the last 12 months.For the temporary occlusion of large vessels the physician used the device 72 times in total of which 54 times were in past 12 months.For combined procedure/emergency care, it was used 21 times in total of which 19 of those 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; embolization (micro or macro) with transient or permanent ischemia (spinal ischaemia with perineal parasthesia (cauda syndrome) as a temporary occurrence, complete remission within 14 days), entry site hematoma (no special features, haematoma was gradually resorbed, no damage (patient was anticoagulated before the operation), aneurysm (clinically irrelevant findings, ct-morphological one to 12 mm proximal aneurysm; no progression (obvious progressive thrombosed), renal complications (possible temporary reduced perfusion of the a.Renalis, so temporary renal dysfunction with increased creatinine.Complete remission within 304 days).The physician found the embolization events somewhat concerning, the entry site hematoma events not at all concerning, the aneurysm events somewhat concerning and not at all concerning, the renal complications somewhat concerning and not at all concerning.Of all of the adverse events, the renal complications was reported to be related to the device on at least one occasion during use of the reliant for temporary occlusion of large vessels, the following complications were encountered; paresthesia (perineal paraesthesia, temporary event) and entry site infection (ordinary infection with delayed healing of the wound).The physician found the paresthesia and the entry site infection events not at all concerning.None of these complications were judged 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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B:5 additional information received.It was also reported that for the use of the reliant for expansion of vascular prothesis, aneurysm ruptures was also encountered (complications were medical in nature and had little to do with the technical part (balloon catheter).The physician found these events not at all concerning.None of these events were found to be related to the device itself.H:6 updated 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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