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

Model Number D-EVOLUTFX-2329

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 12/04/2023

Event Type  Death  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the patient had a left ventricular perforation.The transcatheter aortic valve replacement (tavr) was subsequently converted to cardiac surgery, however the patient passed away.

Manufacturer Narrative

Continuation of d10: product id l-evolutfx-2329; product lot/serial number (b)(6); product type: compression loading system (cls) product id evolutfx-29; product lot/serial number (b)(6); product type: transcatheter aortic valve (tav).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

Continuation of d10: product id non-medtronic extra-stiff guide wire g53971 (lot: unknown); product type: guidewire.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 prior to use of the non-medtronic extra-stiff guidewire, the guidewire was inspected for any bends, kinks or coil separations or other damage and was not manipulated.The guidewire was not twisted or torqued.Subsequently, the guidewire was introduced into the ventricle through the catheter that was already positioned in the ventricle and was placed in the apex of the left ventricle using a pigtail catheter.The guidewire position was monitored visually to ensured that the guidewire transition point was above the apex and pointing away from the ventricle wall using 2 projections to ensured guidewire placement and stability throughout the procedure.No resistance was noted with the guidewire during use.However, the guidewire needed to be repositioned during the procedure.During advancement of the delivery catheter system (dcs), left ventricular perforation (lvp) occurred.Per the physician, the cause of lvp was a non-medtronic extra-stiff guide wire.Also, per the physician, the dcs inability to cross calcified raphe in conjunction with a non-medtronic extra-stiff guide wire cause or contribute to the lvp.In addition, the patient¿s bicuspid aortic valve with fusion of right and noncoronary cusps (rn fusion patter) contributed to the lvp.According to the physician, the cause of death was lvp and the dcs maybe a cause or contributing factor to the patient¿s death.

Manufacturer Narrative

Updated data: h6 - method, result and conclusion codes conclusion: medical safety reviewed the product event and assessed the reported: left ventricular perforation, conversion to open cardiac surgery and death.Based on the information provided, the perforation was likely related to the guidewire.Images confirmed that the guidewire ¿was visibly misshapen at the level of the apex of the left ventricle¿.Per the physician, advancement difficulty of the delivery system to cross the bicuspid aortic valve with fusion of right and noncoronary cusps also contributed to the perforation.The reported adverse events and severities are documented in the risk management files and instructions for use (ifu).No further safety assessment is required at this time.A media file was provided for review.Patient¿s executive summary was not provided for anatomical review.A left ventricular perforation was reported and subsequent death.During valve deployment, the guidewire was visibly misshapen at the level of the apex of the left ventricle.Medtronic best practices recommend maintaining control of guidewire throughout procedure to ensure stable deployment and prevent injury to the ventricle wall: for all wires with a transition point, ensure transition point is held above the apex and pointing away from the ventricle wall.Difficulties advancing the delivery catheter system (dcs) through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.In this case, it was noted that there was calcified raphe.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.Vascular access related complications, such as perforation, are a known potential adverse patient effect per the evolut system ifu, and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Based on the information available, the perforation was likely related to the guidewire.Images confirmed that the guidewire ¿was visibly misshapen at the level of the apex of the left ventricle¿.Per the physician, advancement difficulty of the delivery system to cross the bicuspid aortic valve with fusion of right and noncoronary cusps also contributed to the perforation.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.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.

• Brand Name: EVOLUT FX DCS
• 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: 18273121
• MDR Text Key: 329775926
• Report Number: 2025587-2023-05069
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0011870607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Date Device Manufactured: 07/17/2023
• 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 H10.; SEE H10.
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female