MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number ENVEOR-N |
Device Problem
Difficult to Insert (1316)
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Patient Problems
Intimal Dissection (1333); Injury (2348)
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Event Date 09/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the delivery catheter system (dcs) was discarded, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, via the right femoral artery, resistance was noted during the insertion of the delivery catheter system (dcs).The dcs was pushed and before the completion of the procedure, an angiography revealed an injury near the right external iliac artery.The artery was repaired successfully with a stent.It was reported that the minimum access vessel diameter was 5.3 millimeter (mm).No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Additional information was received that the injury was a dissection of the iliac artery.No additional adverse patient effects were reported. updated h.6 patient code.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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