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 01/30/2023 |
Event Type
Injury
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the inline sheath of the delivery catheter system (dcs) was inserted via the puncture site, but the inline sheath of the dcs was unable to pass through the patient¿s anatomy and the common femoral artery.The inline sheath was replaced with an 18fr sheath.An 18fr sheath was inserted and the valve was implanted successfully.Following the implant, contrast study was performed on the vessels in the lower extremities; damage to the intima was observed.Subsequently, a vascular stent was placed, and treatment was performed.Per the physician, it is not possible to specify whether the inline sheath or an 18fr sheath was the cause of the damage to the intima.No additional adverse patient effects were reported.
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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.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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Manufacturer Narrative
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Additional information was received that the access site for the delivery catheter system (dcs) was the right transfemoral artery.It was reported that the dissection occurred on the right side during the procedure.Per the physician, either the in-line sheath or 18fr sheath caused the dissection.The patient had narrow anatomy with calcification that may have contributed to the advancement issue and dissection.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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