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

Model Number D-EVOLUTFX-34

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923); Activation Failure (3270); Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10:  product id evolutfx-34 (serial: (b)(6)); product type: 0195-heart valves; implant date n/a; explant date n/a product id l-evolutfx-34 (serial: unknown); product type: 0195-heart valves; implant date n/a; explant date n/a section d references the main component of the system.Other medical products in use during the event include: brand name evolut fx valve; product id evolutfx-34 (serial: (b)(6)); product type: 0195-heart valves; implant date (b)(6) 2024; explant date (b)(6) 2024 h6.The codes present in section h6 correspond to multiple components/products that comprise this reported event.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.  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 implant of this transcatheter bioprosthetic valve ((b)(6)), the valve was loaded and checked under fluoroscopy.A pre-implant balloon aortic valvuloplasty (bav) was performed using a 24-millimeter (mm) non-medtronic (true) balloon.The balloon was accidentally inflated in the left ventricle, therefore, a bav was not performed on the calcified native aortic valve.At 80% deployment, the valve was 4 mm on the non-coronary cusp (ncc) and 2 mm on the left coronary cusp (lcc).The valve appeared constrained in the right anterior oblique (rao) view.The physician opted to deploy the valve.The non-medtronic (safari) guidewire was pulled back, but the guidewire tip was not completely into the nose cone of the delivery catheter system (dcs).The valve subsequently dislodged above the annulus.A snare was used to pull the valve higher with the inflow of the frame just above the level of the left coronary artery.It was unable to be determined if the valve started moving aortic upon deployment, or if the nose cone of the dcs caught on the inflow of the valve upon removal of the dcs.It was suspected that a combination of both occurred.A second valve ((b)(6)) was loaded and checked under fluoroscopy.The system was advanced, but when the dcs got to the frame of the first valve in the ascending aorta, the dcs was pushing the outflow of the frame down.A second snare was used to attempt to grab the greater curve paddle to pull the valve higher but was not successful.It was clear that a second valve could not be deployed based on position of the first valve due to the risk of a coronary occlusion of the first valve frame inflow in front of the left coronary artery.There were also concerns of continuing to push on the valve with the second system.Subsequently, the system was withdrawn, and the procedure was aborted.The patient was stable for the entire procedure.The following day, the valve (b)(6)) was explanted.The physician reported that a dissection was observed due to the valve tearing the aorta above the right coronary artery.It was noted that this would have lined up with the inflow of the valve frame when trying to advance the second system.A new 25 mm medtronic surgical aortic valve was implanted, and a surgical root repair was performed due to the dissection of the aorta.It was noted that the dissection occurred from the proximal aorta to the right coronary artery.The patient was reported as doing well.It was noted that during the procedure, the training guidance for slow deployment of the valve was followed.Prior to slowly withdrawing the dcs, the nosecone was centered within the frame inflow by slightly retracting the guidewire.The dcs was not twisted or torqued during deployment, and the cause of the dislodgement was due to the combination of nose cone interaction and incomplete frame expansion of the first valve.Additionally, a procedure delay occurred of approximately 2 hours.It was further reported that the bav that was performed in the left ventricle instead of being performed in the calcified native aortic valve, caused/contributed to the event.No additional adverse patient effects were reported.

• 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: 18908210
• MDR Text Key: 337729195
• Report Number: 2025587-2024-01661
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: 00763000365684
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0012056318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Date Device Manufactured: 11/29/2023
• 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; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 111 KG