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

Model Number D-EVOLUTFX-2329

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Stenosis (2263)

Event Date 11/08/2022

Event Type  Death  

Manufacturer Narrative

Product analysis: the valve remains implanted and the dcs 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 during implant of this transcatheter bioprosthetic valve, access was obtained in the left and right common femoral artery and left common femoral vein.Pigtail catheter was placed in the aortic root and temporary pacing was placed.An introducer sheath was placed with minimal difficulty in the right common femoral artery as it was stenotic.An 18 mm non medtronic balloon was used for pre-implant balloon aortic valvuloplasty (bav).The sheath was removed and placed with the delivery catheter system (dcs).The valve was deployed in an inline fashion in a good position and no paravalvular leak (pvl) observed.The dcs was retrieved from the patient. a delivery sheath from the right femoral artery and closure devices were tightened.Total hemostasis was observed at the right femoral artery site.From the left side, a pigtail catheter was advanced over the aortic bifurcation and selective angiography of the right external iliac and common femoral vessels was performed.The angiography revealed 90% stenosis of the right external iliac artery above the level of the access site.Using a non-medtronic peripheral guidewire across the lesion, the introducer sheath was exchanged for a 6 french (fr) non-medtronic sheath.Through the new sheath, a 6 x 4 balloon was advanced and a single balloon dilation was performed at the lesion site with 40% residual stenosis.The left femoral artery sheath was removed and a closure device was used. of note, the patient's calcification contributed to the deployment issue.The area was dilated and the sheath was removed and the vessel was closed with the previously placed closure device.At the end of the procedure, the patient developed aphasia.A stroke code was called and a thrombectomy was performed and medication was administered.At the end of the stroke intervention, the patient was unstable with low blood pressures.The patient responded to medications initially and first unit of packed red blood cells (prbcs).A second unit of prbc's was started along with weaning of medications.The reasons for the prbc's and the amount of blood loss was unknown.Preparations were made to transport the patient to computed tomography (ct) scanning but their blood pressure plummeted.Resuscitation measures were performed. pulseless electrical activity (pea) then ventricular fibrillation was observed.The patient was shocked a 2-3 times back to pea.Despite the resuscitation efforts, the patient died.

• 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: 16287747
• MDR Text Key: 308700955
• Report Number: 2025587-2023-00380
• 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: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• 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: 0011424293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Date Device Manufactured: 09/27/2022
• 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; Death; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female