MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number D-EVPROP2329US |
Device Problem
Failure to Advance (2524)
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Patient Problem
Vascular Dissection (3160)
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Event Date 04/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the device was discarded; therefore, no product analysis can be performed.Conclusion: without the 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 attempted implant of this transcatheter bioprosthetic valve, via right transfemoral artery access with a minimum vessel diameter greater than or equal to 5mm, the delivery catheter system (dcs) could not advance.A non-medtronic balloon was positioned at the stenosis site; however, efforts were unsuccessful.The dcs was withdrawn from the patient; no valve was implanted.While performing hemostasis, a dissection occurred.The patient was placed on cardiopulmonary bypass for surgical treatment to address the damaged blood vessel.Per the physician, the cause of the injury was due to the non-medtronic introducer sheath or possibly the dcs in-line sheath access.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received that the iliac artery was damaged and bleeding was noted.Subsequently, a femoral-femoral bypass was performed.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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