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

Model Number EVOLUTFX-29

Device Problems Perivalvular Leak (1457); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Valvular Insufficiency/ Regurgitation (4449); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted 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 during the implant of this 29mm transcatheter bioprosthetic valve, five deployment attempts were made with the starting point at the bottom of the pigtail catheter, but the valve repeatedly dislodged into the ascending aorta during deployment.The patient's pressure dropped, rapid pacing was initiated at 180 beats per minute and anesthesia tried to manage the hypotension, but the valve continued to dislodge back into the aorta during deployment.A non-medtronic guidewire was replaced with a medtronic guidewire.The valve continued to dislodge.The valve was intentionally deployed at a depth of 10mm on the non-coronary cusp (ncc) and 7mm on the left coronary cusp (lcc).Upon release, the valve dislodged ventricular to an implant depth greater than 24mm deep on both the ncc and lcc; it was reported the valve was only articulated at the outflow portion of the valve frame which resulted in moderate-severe paravalvular leak (pvl) and caused the mitral regurgitation to progress from trace to mild.The valve was snared to hold it in place while a second 29mm medtronic valve was implanted at a higher position.The pvl reduced to moderate.A p ost-implant bav was performed with a 23mm non-medtronic balloon and reduced the pvl to mild.It was noted the patient's anatomy may have contributed to the dislodgements as there was not a typical septal bulge seen.In addition, the left ventricle narrowed but only after more than 8mm in the ventricle.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Paravalvular leak (pvl) and regurgitation can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.With the limited information available, a conclusive root cause could not be determined but the dislodgement was a likely contributing cause.Potential factors that can influence a dislodged valve include tension applied on the delivery catheter system (dcs) during positioning, calcification levels in the native vessel, and compliance of the aorta and native vessels.With the limited information available a conclusive root cause could not be determined, but the patient's anatomy may have contributed to the dislodgements as there was not a typical septal bulge seen.Dislodge events are typically not related to a device malfunction.This event does not indicate device misuse or malfunction.Updated: h6.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 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: 15963653
• MDR Text Key: 305331910
• Report Number: 2025587-2022-03515
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: 00763000370701
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2024
• Device Model Number: EVOLUTFX-29
• Device Catalogue Number: EVOLUTFX-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 03/10/2023
• Date Device Manufactured: 08/18/2022
• 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: 77 YR
• Patient Sex: Male