EVOLUT FX DCS
Report
- Report Number
- 9612164-2025-05968
- Event Type
- Malfunction
- Date Received
- December 2, 2025
- Date of Event
- November 24, 2025
- Report Date
- February 6, 2026
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NPT
- UDI-DI
- 00763000944476
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
CONTINUATION OF D10: PRODUCT ID L-EVOLUTFX-34 (LOT: 0012857318); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVOLUTFX-34 (K115431); PRODUCT TYPE: 0195-HEART VALVES; SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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.
IMAGE REVIEW: THREE IMAGES WERE PROVIDED FOR REVIEW. IN THE LEFT ANTERIOR OBLIQUE VIEW, THERE WAS A CLEAR LINE INDICATING AN INFOLD IN THE VALVE AT THE POINT OF NO RECAPTURE. 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.
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 A PATIENT WITH A TRICUSPID MODERATE TO SEVERE CALCIFIED AORTIC VALVE UNDERWENT A PROCEDURE INVOLVING ATTEMPTED PREDILATATION FOUR TIMES WITH A NON-MEDTRONIC 25MM BALLOON (OSYPKA VACS III), BUT THE BALLOON COULD NOT BE KEPT STABLE AND CENTERED IN THE AORTIC VALVE DURING INFLATION. THE IMPLANTERS DECIDED TO PROCEED WITH IMPLANTATION OF AN EVOLUT FX 34 MILLIMETER (MM) VALVE. FLUOROSCOPY WAS USED TO CHECK THE VALVE PRIOR TO PREDILATATION, CONFIRMING IT WAS CORRECTLY LOADED WITHOUT SIGNS OF CELL OVERLAP. THE FIRST POSITIONING ATTEMPT OF THE EVOLUT FX 34MM VALVE WAS TOO VENTRICULAR AT APPROXIMATELY 6 MM DEPTH. THE VALVE WAS RECAPTURED AND REPOSITIONED HIGHER, BUT ANCHORING WAS LOST AND THE VALVE MOVED TOWARD THE AORTIC POSITION. THE VALVE WAS RECAPTURED ABOVE THE NATIVE AORTIC VALVE AND REPOSITIONED, ACHIEVING A GOOD DEPTH OF APPROXIMATELY 2 MM. HOWEVER, IMAGING IN THE LEFT ANTERIOR OBLIQUE VIEW REVEALED A CLEAR LINE INDICATING INFOLDING AT THE FRAME OF THE EVOLUT FX 34MM VALVE. THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. DUE TO THE INABILITY TO ACHIEVE STABLE PREDILATATION, THE IMPLANTERS DECIDED NOT TO ATTEMPT IMPLANTATION WITH A SECOND 34MM EVOLUT VALVE AND INSTEAD IMPLANTED A 29MM NON-MEDTRONIC VALVE (SAPIEN RESILIA) WITHOUT PREDILATATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEPLOYMENT STARTING POINT WAS MID PIGTAIL CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2736060 | EVOLUT FX DCS | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC IRELAND | D-EVOLUTFX-34 | 0012752491 | 00763000944476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SEE H11... |