MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVOLUTFX-26

Device Problems Difficult or Delayed Positioning (1157); Failure to Advance (2524); Difficult or Delayed Activation (2577); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id l-evolutfx-2329 (lot: 0011945515); product type: 0195-heart valves; product id d-evolutfx-2329 (lot: 0011966443); 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.

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the valve dislodged after deployment and was explanted.A second valve was attempted to be implanted, however this was unsuccessful therefore a thoracotomy was performed.  following the thoracotomy, a second valve was successfully placed in the ascending position.No additional adverse patient effects were reported.

Manufacturer Narrative

Imf annex f health impact code f26 was omitted from this report and corrected to f12.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 during the valve implant procedure, a pre-implant balloon aortic valvuloplasty (bav) was pe rformed.No post-implant bav was performed.The deployment starting point was the bottom of the pigtail catheter.During deployment, one paddle was difficult to remove, and when the implanting physician attempted to remove it, the physician pulled the valve and the valve dislodged.Prior to the valve dislodgement, the valve was implanted at a depth of approximately 3mm on the non-coronary cusp and 3mm on the left coronary cusp.Subsequently, the valve dislodged aortic.After the valve dislodgement, the valve stopped to the ascending line.Then an attempt was made to place a second valve, but the fist valve interfered, and the delivery catheter system could not pass through.As a result, the patient had to undergo thoracotomy, and the area where the dissection occurred underwent ascending aorta replacement and valve replacement.A non-medtronic guidewire was used during the procedure.It was noted that anatomically, there was strong torsion in both the descending and ascending directions, but it was unclear whether this was the direct cause of the dislodgment.No adverse patient effects were reported.

Manufacturer Narrative

Information references the main component of the system.Other relevant device is: product id: d-evolutfx-2329, lot #: 0011966443, ubd: 22-sep-2025, udi#: (b)(4) product id: non-medtronic balloon, unknown manufacturer product id non-medtronic guidewire (lot: unknown); product type: guidewire; implant date n/a; explant date n/a updated data: b5.Additional codes: annex f annex g 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

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 regarding the events that occurred during the implant procedure that clarifies previously reported information.There were no problems with loading the valve.During the procedure, the delivery catheter system (dcs) was advanced to the descending aorta.Cuspal overlap technique (cot) was used during the procedure.Imaging was performed that revealed the hat marker dislodged.The center of the valve was moved back to the descending position and was adjusted.The valve was then deployed.During deployment, the paddles were difficult to release, and the valve subsequently dislodged.During the attempted implant of the second valve, gripping the paddles of the lesser curvature with a snare was not possible so the guidewire was changed to a non-medtronic (lunderquist) guidewire.A 22 mm non-medtronic balloon was placed outside of the first valve frame to shift the valves orientation.The second valve was pulled through with a non-medtronic (radifocus 400) guidewire inserted through the right arm.Subsequently, the dcs penetrated the aortic root, so it was decided to convert to a thoracotomy.The right side was used as the access site for the dcs.The minimum diameter of the access vessel was 6.6-6.7 millimeter¿s (mm).The dissection occurred at the end of the procedure.In terms of patient anatomy, there was tortuosity in the abdomen and descending aorta that contributed to the dissection.It was noted that the access vessels had kinks in the descending aorta, aortic arch, and ascending aorta.Additionally, the pre-implant bav was performed using a non-medtronic (z-med) 18mm-20mm balloon.It was further reported that following the procedure, there was suspicion that the patient had a cerebral infarction.No treatment was provided.No additional adverse patient effects were reported.

Event Description

Additional information was received that the stroke was confirmed by computed tomography (ct) and the patient was hospitalized.No patient symptoms were observed following the valve implant.It was unknown if they patient had any pre-existing factors that contributed to the stroke.

Manufacturer Narrative

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.

Manufacturer Narrative

Corrected data: b5.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.

Event Description

Additional information was received that the same dcs was used to deploy both valves.No additional adverse patient effects were reported.

Event Description

Additional information was received that, per the physician, the cause of the dissection was when the second valve was placed, the delivery catheter system (dcs) was forcibly pushed through the first valve.Per the physician, the dcs cause or contribute to the dissection.No adverse patient effects were reported.

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.

Event Description

Additional information was received clarifying that, during the attempted implant of the second valve, gripping the paddles of the l esser curvature with a snare was possible, but gripping the paddles of the greater curvature with a snare was not possible.A 22 mm non-medtronic balloon was not used but a 12 mm non-medtronic balloon was used.Under cine, it appeared that the delivery catheter system (dcs) penetrated the aortic root but it was confirmed to not have occurred.

Manufacturer Narrative

Updated data: b5 h6 - patient code e0515 no longer applicable to this event.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.

• Brand Name: EVOLUT FX VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18710664
• MDR Text Key: 335465351
• Report Number: 2025587-2024-00894
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLUTFX-26
• Device Catalogue Number: EVOLUTFX-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Date Device Manufactured: 10/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11...; SEE H11...
• Patient Outcome(s): Required Intervention; Hospitalization