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 15 years, who has used the reliant device for expansion of vascular prostheses 12 times over the last 12 months and used it 8 times in total in the last 12 months for the temporary occlusion of large vessels.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; blood loss/bleeding (above-normal hb -relevant bleeding), hematoma (above-normal haematoma formation), embolization (micro or macro) with transient or permanent ischemia (ischaemic stroke), vessel perforation or dissection (vascular trauma requiring further surgery) , general malaise, entry site hematoma (above-average haematoma on the puncture), entry site infection (infection requiring antibiotics), hemorrhage (drop in thrombocytes blood loss) , renal complications (acute kidney failure until dialysis).The physician found the blood loss events somewhat concerning and not at all concerning, the hematoma events were not at all concerning, the embolization events very concerning, the vessel perforation or dissection events somewhat concerning, the general malaise events not at all concerning, the entry site infection events not at all concerning, the entry site haematoma events not at all concerning, the hemorrhage events somewhat concerning and not at all concerning, and the renal complications not at all concerning and somewhat concerning.Of the these adverse events 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; vessel perforation or dissection (dissection of the vessel with another operation needed), general malaise [az] reduction) , entry site hematoma (formation of a significant haematoma), stroke (ischaemic stroke) and renal complications (acute renal failure).The physician found the vessel perforation or dissection events very concerning, the general malaise events somewhat concerning and not at all concerning, the entry site haematoma events not at all concerning, the stroke events somewhat concerning, the renal complications somewhat concerning and not at all concerning.None of these complications were 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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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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