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); Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 12/28/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Medtronic received information that prior to the attempted implant of this transcatheter bioprosthetic valve via right transfemoral access, it was noted that the patient had significantly calcified anatomy and the minimum diameter of the access vessel was 4.1 millimeter (mm).During attempted implant, the delivery catheter system (dcs) was unable to advance through the calcification in the right iliac artery.An attempt was made to balloon and shockwave the access site, however, this was unsuccessful.Once an hour delay was noted, the dcs was withdrawn from the patient and the valve was loaded onto a new dcs.However, the same issue occurred with the second dcs.The physician considered an alternate access site; however, it was reported the patient did not want an alternate access.Subsequently, the procedure was aborted.The valve was not implanted.It was reported that a tear in the right iliac artery was observed, and cutdown was performed to repair the damage.It was reported that the vascular repair was successful.Per the physician, the severe disease in the patient¿s anatomy caused the tear in the right iliac artery.Per the physician, the dcss did not cause or contribute to the injury.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: it was reported that the delivery catheter system (dcs) was unable to advance through the calcification in the right iliac artery.Difficulties advancing the 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 the patient had significantly calcified anatomy.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.It was reported that the minimum diameter of the access vessel was 4.1mm.Per the evolut fx instructions for use (ifu), ¿patients must present with transarterial access vessels with diameters that are =5.0 mm when using model d-evolutfx-2329¿.This indicates off-label use.Vascular complications, such as dissection, are a known potential adverse patient effect per the evolut fx system instructions for use (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 limited information available, an assignable root cause of the vascular compl ication cannot be determined and a relationship to the dcs could not be established.Per the physician, the severe disease in the patient¿s anatomy caused the tear in the right iliac artery.Per the physician, the dcs did not cause or contribute to the injury.There was no information to suggest that 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.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.

• 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: 16471537
• MDR Text Key: 310588445
• Report Number: 2025587-2023-00782
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000365677
• UDI-Public: 00763000365677
• 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
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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: 0011481794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Date Device Manufactured: 11/01/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female