MEDTRONIC HEART VALVES DIVISION EVOLUT FX DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number D-EVOLUTFX-2329 |
Device Problems
Failure to Advance (2524); Patient Device Interaction Problem (4001)
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Patient Problems
Hemorrhage/Bleeding (1888); Perforation (2001); Vascular Dissection (3160)
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Event Date 01/29/2024 |
Event Type
Death
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Manufacturer Narrative
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Continuation of d10: product id evolutfx-29 (serial: (b)(6)); product type: 0195-heart valves.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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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the implanting physician could not advance the delivery catheter system (dcs) over a non-medtronic wire.Subsequently, the implanting physician rotated the device appropriately and upon readvancing, the dcs caused perforation of the aortic arch and the patient bled out.It was noted that the patient was unable to recover leading to death.The cause of death was not received.No further information was provided.
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Event Description
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Additional information was received that per the physician, the cause of death was aortic dissection.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Updated h.6 intra procedural fluoroscopic images were provided for review of the event description above.Patient¿s executive summary was provided for anatomical review.Patient¿s annulus perimeter measured 79.8mm with a perimeter derived diameter of 25.4mm suggesting a 29mm evolut.The aorta did not appear to be significantly tortuous; however, there was calcification near the great vessels.A pre balloon aortic valvuloplasty was performed prior to the valve deployment attempt.It was reported that the implanting physician could not advance the delivery catheter system.As stated in the instructions for use (ifu), during use there will be some resistance when the catheter is advanced through the vasculature.If there is a significant increase in resistance, stop advancement and investigate the cause of the resistance (for example, magnify the area of resistance) before proceeding.Do not force passage.Forcing passage could increase the risk of vascular complications (for example, vessel dissection or rupture).It was reported that further attempts to advance the delivery catheter system caused a perforation of the aortic arch.Evidence shows a kink in the guidewire and a perfora tion of the aortic arch confirmed by the contrast extravasation.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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