EVOLUT FX DCS
Report
- Report Number
- 2025587-2025-04102
- Event Type
- Malfunction
- Date Received
- June 6, 2025
- Date of Event
- June 3, 2025
- Report Date
- August 28, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- UDI-DI
- 00763000365677
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPDATED H.6. 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.
CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-2329 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE 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-29 (SERIAL: K070083); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE 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.
UPDATED DATA: D4 H2 H3 H6 PRODUCT ANALYSIS: UPON RECEIPT OF THE SYSTEM REPORTED COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE VALVE WAS RECEIVED IN A HEART VALVE RETURN KIT JAR, FULLY SUBMERGED IN A CLEAR 0.2% GLUTARALDEHYDE SOLUTION. THE VALVE WAS DISCOLORED, SHOWING EVIDENCE OF BLOOD CONTACT. THE VALVE WAS RECEIVED IN A COMPRESSED STATE. ALL LEAFLETS EXHIBITED SIGNS OF CREASES AND FRAME IMPRINTS. THE LEAFLETS WERE STIFF YET SLIGHTLY FLEXIBLE. LEAFLETS L1, L2 WERE IN THE CLOSED POSITION. LEAFLET L3 WAS IN THE OPEN POSITION. ALL COMMISSURES APPEARED INTACT. THE VALVE WAS SUBMERGED IN BODY-TEMP (APPROXIMATELY 37 CELSIUS) SALINE. THE FRAME EXPANDED; HOWEVER, IT RETAINED A COMPRESSED STATE. DUE TO THE RECEIVED CONDITION, A DEPLOYMENT SIMULATION TO EVALUATE AGAINST THE ALLEGED EVENT OF FRAME INFOLDING CANNOT BE PERFORMED. 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.
UPDATED: B5, D4, H4, 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.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE, THE VALVE WAS DEPLOYED TO 80% AND THEN DISLODGED ABOVE THE ANNULUS. THE VALVE WAS RECAPTURED AND REDEPLOYED AT A DEPTH OF APPROXIMATELY THREE MILLIMETERS ON THE NON-CORONARY SIDE, BUT AGAIN DISLODGED ABOVE THE ANNULUS AT 80% DEPLOYMENT. AN IN-FOLD OF THE VALVE WAS NOTED. THE VALVE WAS RECAPTURED AND ANOTHER DEPLOYMENT ATTEMPT WAS MADE, RESULTING IN THE SAME ISSUE. ANOTHER VALVE WAS THEN LOADED AND, AFTER ONE RECAPTURE, WAS DEPLOYED IN A SATISFACTORY POSITION WITHOUT THE NEED FOR POST-BALLOON AORTIC VALVULOPLASTY.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE, THE VALVE WAS DEPLOYED TO 80% AND THEN DISLODGED ABOVE THE ANNULUS. THE VALVE WAS RECAPTURED AND REDEPLOYED AT A DEPTH OF APPROXIMATELY THREE MILLIMETERS ON THE NON-CORONARY SIDE, BUT AGAIN DISLODGED ABOVE THE ANNULUS AT 80% DEPLOYMENT. AN IN-FOLD OF THE VALVE WAS NOTED. THE VALVE WAS RECAPTURED AND ANOTHER DEPLOYMENT ATTEMPT WAS MADE, RESULTING IN THE SAME ISSUE. ANOTHER VALVE WAS THEN LOADED AND, AFTER ONE RECAPTURE, WAS DEPLOYED IN A SATISFACTORY POSITION WITHOUT THE NEED FOR POST-BALLOON AORTIC VALVULOPLASTY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOADING WAS PERFORMED BY AN EXPERIENCED LOADER. PER THE PHYSICIAN, THE PATIENT ANATOMY MAY HAVE CONTRIBUTED TO THE INFOLD AS THE VALVE PERIMETER WAS APPROXIMATELY 78 MM AND IT WAS ACKNOWLEDGED IN A PRE-CASE DISCUSSION THAT THERE WAS SOME CALCIUM EVIDENT AT THE ANNULAR LEVEL. A MINIMAL PROCEDURAL DELAY MAY HAVE OCCURRED DUE TO LOADING ANOTHER VALVE AND PERFORMING A PRE-IMPLANT BALLOON DILATION PRIOR TO DEPLOYMENT WHICH INITIALLY WAS NOT DONE. THE SUBSEQUENT DEPLOYMENT OF THE SECOND VALVE WENT PERFECTLY WITH A GREAT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719871 | EVOLUT FX DCS | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | D-EVOLUTFX-2329 | 0012402673 | 00763000365677 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | SEE H11 |