MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
|
Back to Search Results |
|
Model Number EVOLUTFX-26 |
Device Problems
Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
|
Patient Problems
Cardiac Arrest (1762); Rupture (2208); Cusp Tear (2656)
|
Event Date 09/01/2023 |
Event Type
Death
|
Manufacturer Narrative
|
Section d references the main component of the system.Other relevant device is: product id: d-evolut2329 lot #: 0011427461; ubd: 2024-09-27; udi: (b)(4).Other medical products in use during the event include: product id l-evprop2329us (lot: 0011165255); product type: 0195-heart valves; product id: 18mm trueflow dilatation balloon valvuloplasty catheter (non-medtronic device); lot #: unknown, product id: 12mm mustang dilatation balloon valvuloplasty catheter (non-medtronic device); lot #: unknown.Product analysis: no product was returned and no procedural images were submitted for review; 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.
|
|
Event Description
|
Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, the native aortic valve was crossed with a straight guidewire, dual pressures were recorded, and an 18mm non-medtronic balloon was attempted, but would not cross the valve.A 12mm non-medtronic balloon was used for a pre-implant balloon aortic valvuloplasty (bav), allowing the 18mm balloon to cross and perform another bav.Following the bav, the valve was inserted using the inline technique.After the valve was attempted for deployment twice and recaptured into the delivery catheter system due to an unknown reason, it was fully deployed.A post-implant angiogram was performed, and an annular rupture was observed.The patient went into cardiac arrest.Resuscitation attempts along with defibrillations were performed for approximately 40 minutes, however, were unsuccessful and the patient subsequently died.The suspected cause of death was due to the pre dilation causing an aortic dissection, or multiple valve crossing attempts and placement of the medtronic valve.
|
|
Event Description
|
Additional information was received that during the implant, two recaptures were performed.Per the physician, the cause of death was annular rupture/tear due to possible pre-implant balloon aortic valvuloplasty.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Updated data: b5.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.
|
|
Event Description
|
Additional information was received that due to the patient challenging anatomy and the implant depth being too high, the valve was recaptured to place it at 3mm depth.No adverse patient effects were reported.
|
|
Search Alerts/Recalls
|
|
|