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

Model Number EVOLUTFX-34

Device Problems Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001); Central Regurgitation (4068)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271); Valvular Insufficiency/ Regurgitation (4449)

Event Date 03/14/2024

Event Type  Death  

Manufacturer Narrative

Continuation of d10: product id: {d-evolutfx-34}; product type: {0195-heart valves}.Product id: {l-evolutfx-34}; product type: {0195-heart valves}.Product id: {non-medtronic endograft}; product type: {endograft}.Product id: {26 mm non-medtronic transcatheter valve}; product type: {transcatheter valve}.Product id: {non-medtronic transcatheter valve}; product type: {transcatheter valve}; implant date: (b)(6) 2024.Product id: {non-medtronic delivery catheter system}; product type: {delivery catheter system}.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.  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

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, inside a patient with a bicuspid aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed using a non-medtronic balloon.The valve was implanted at 3 millimeters¿ (mm), however, the systolic pressure was over 260 millimeters of mercury (mm hg).The valve subsequently dislodged into the ascending aorta.In result, wide open aortic regurgitation occurred.A non-medtronic 26 mm valve was attempted to be implanted, however, the implant depth was deep, so a non-medtronic 29 mm valve was implanted.The patient was stable at this time.The physician decided that the medtronic transcatheter valve needed to be moved to the descending aorta.Upon attempting to snare the valve, the valve was mangled and would not move further than just distal of the subclavian artery.At that point, the valve could not be straightened so it was decided to use a non-medtronic endograft to open the valve allowing for blood flow.It was also noted that the patient had an effusion, so a chest tube was subsequently placed.Following the placement of the endograft, it was decided to post-dilate as the graft was constrained.Following dilation, the patient¿s blood pressure dropped, and a small perforation was noted.A second graft was used to try and seal the leak.The leak was unable to be corrected endovascularly and it was determined that there was no surgical option.The patient subsequently died shortly after.Per the physician, attempting to move the valve from the ascending aorta to the descending aorta following the dislodge, contributed to the death.

Manufacturer Narrative

Updated data: b5.Continuation of d10: product id: d-evolutfx-34; product type: delivery catheter system; product id: boston scientific safari; product type: guidewire.H6 - method code for the concomitant device 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 during the implant, per the physician, the cause of the dislodged could possibly be the valve getting caught by the nose cone of the delivery catheter system (dcs) and the patient's systolic pressure.There was no patient anatomical features that contributed to the dislodge.During deployment, the starting point was at the bottom of the pigtail at an implant depth of 3 millimeter (mm) on the non-coronary cusp (ncc) and 3 mm on the left coronary cusp (lcc) using a non-medtronic (safari) guidewire.Per the physician, the cause of the perforation was the valve moving from the ascending aorta to just past the subclavian and subsequent dilation pushing the outflow crowns of the valve into the blood vessel with the balloon.The cause of the pericardial effusion was due to wire management.Per the physician, the valve did not cause or contribute to the pericardial effusion.

Manufacturer Narrative

Updated data: a3b continuation of d10: product id d-evolutfx-34; product lot 0011721718; product type: delivery catheter system; h6 additional codes 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

Image review: procedural images were provided and upon review the valve was deployed to just prior the point of no recapture and depth assessment was performed.The depth at the non-coronary cusp was approximately 3mm; however, it appeared to be significantly under expanded/constrained which would warrant a recapture.Though, the valve was released which resulted in aortic dislodgment.There were no images provided showing the mechanism of dislodgement.No further images were provided to validate the aortic perforation.Updated h6.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: 18952635
• MDR Text Key: 338270467
• Report Number: 2025587-2024-01829
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370718
• UDI-Public: 00763000370718
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLUTFX-34
• Device Catalogue Number: EVOLUTFX-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 03/25/2024; 04/09/2024; 05/21/2024
• Supplement Dates FDA Received: 04/09/2024; 04/23/2024; 05/28/2024
• Date Device Manufactured: 11/03/2023
• 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
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 75 YR
• Patient Sex: Male