EVOLUT FX DCS
Report
- Report Number
- 9612164-2025-05974
- Event Type
- Malfunction
- Date Received
- December 2, 2025
- Date of Event
- November 11, 2025
- Report Date
- January 7, 2026
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NPT
- UDI-DI
- 00763000822194
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID EVFXPLUS-34 (R033978); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE N/A; EXPLANT DATE N/A 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.
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 PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO THE PATIENT'S BICUSPID AORTIC VALVE. UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE DISLODGED AND WAS SUBSEQUENTLY RECAPTURED. DURING RECAPTURE, AN INFOLD WAS OBSERVED. IT WAS NOTED THAT THE TARGET IMPLANT DEPTH WHEN THE INFOLD OCCURRED WAS 3 MILLIMETERS (MM). A SECOND DEPLOYMENT ATTEMPT WAS PERFORMED; HOWEVER, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT AND A NEW VALVE WAS USED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT'S BICUSPID NATIVE VALVE CONTRIBUTED TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO THE PATIENT'S BICUSPID AORTIC VALVE. UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE DISLODGED AND WAS SUBSEQUENTLY RECAPTURED. DURING RECAPTURE, AN INFOLD WAS OBSERVED. IT WAS NOTED THAT THE TARGET IMPLANT DEPTH WHEN THE INFOLD OCCURRED WAS 3 MILLIMETERS (MM). A SECOND DEPLOYMENT ATTEMPT WAS PERFORMED; HOWEVER, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT AND A NEW VALVE WAS USED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT'S BICUSPID NATIVE VALVE CONTRIBUTED TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC (SAFARI) GUIDEWIRE WAS USED FOR THE PROCEDURE. THE DEPLOYMENT STARTING POINT WAS THE BOTTOM OF THE PIGTAIL CATHETER. THE DIRECTION OF DISLODGEMENT WAS AORTIC. PRIOR TO VALVE DISLODGEMENT, THE IMPLANT DEPTH WAS 3 MM ON THE NON-CORONARY CUSP (NCC) AND LEFT CORONARY CUSP (LCC). AFTER THE VALVE DISLODGEMENT, THE IMPLANT DEPTH WAS 4 MM ON THE NCC AND LCC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1899005 | EVOLUT FX DCS | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC IRELAND | D-EVOLUTFX-34 | 0012792526 | 00763000822194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | SEE H11... |