EVOLUT FX DCS
Report
- Report Number
- 9612164-2026-02748
- Event Type
- Death
- Date Received
- May 27, 2026
- Date of Event
- May 19, 2026
- Report Date
- May 27, 2026
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NPT
- UDI-DI
- 00763000944469
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID EVFXPLUS-26 (SERIAL: R276092); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID L-EVOLUTFX-2329 (LOT: 0013272776); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0013365664); 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.
UPDATED DATA: B5, A THIRD PARAGRAPH WAS ADDED. 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: ONE MEDIA IMAGE WAS PROVIDED. THERE WAS NO EXECUTIVE SUMMARY OR COMPUTED TOMOGRAPHY (CT) PROVIDED FOR ANATOMICAL CONSI DERATION. IN ORDER TO ACCURATELY ASSESS DEPTH ON THE NON-CORONARY CUSP, THE VIEW SHOULD BE THE PRE-DETERMINED CUSP OVERLAP PROJECTION DERIVED FROM CT IMAGES. IN ORDER TO ASSESS DEPTH ON THE LEFT CORONARY CUSP, THE VIEW SHOULD ROLL FROM THE PRE-DETERMINED CUSP OVERLAP VIEW LAO NO GREATER THAN 25 DEGREES OF LAO AND REMOVED PARALLAX FROM THE VALVE. EVIDENCE PROVIDED DOES NOT STATE IMAGING PROJECTION THEREFORE THE DEPTH CANNOT BE CONFIRMED. DESPITE THE VIEW, EVIDENCE SUGGESTS THE VALVE DEPTH ON THE LEFT TO BE >15 MM. PER MEDTRONIC INSTRUCTIONS FOR USE, IF THE VALVE IS >5 MM A RECAPTURE IS RECOMMENDED. IT WAS REPORTED THAT FOUR POSITIONING ATTEMPTS WERE MADE, AND THE PHYSICIAN DECIDED NOT TO PROCEED WITH IMPLANTATION. UPDATED DATA: B2, B5, 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 RIGHT SUBCLAVIAN ACCESS PROCEDURE INVOLVING AN EVOLUT 26 FX+ TRANSCATHETER AORTIC VALVE, THE VALVE KEPT POSITIONING VERY LOW ON THE LEFT CORONARY CUSP. FOUR POSITIONING ATTEMPTS WERE MADE, AND THE PHYSICIAN DECIDED NOT TO PROCEED WITH IMPLANTATION. DURING THE PROCEDURE, A PERICARDIAL TAMPONADE WAS DISCOVERED. CARDIAC SURGEONS INTERVENED EMERGENTLY TO TREAT THE TAM PONADE AND PERFORMED AN AORTIC VALVE REPLACEMENT WITH A SURGICAL VALVE. THE PATIENT DID NOT SURVIVE THE SURGICAL OPERATION.
IT WAS REPORTED THAT DURING A RIGHT SUBCLAVIAN ACCESS PROCEDURE INVOLVING AN EVOLUT 26 FX+ TRANSCATHETER AORTIC VALVE, THE VALVE KEPT POSITIONING VERY LOW ON THE LEFT CORONARY CUSP. FOUR POSITIONING ATTEMPTS WERE MADE, AND THE PHYSICIAN DECIDED NOT TO PROCEED WITH IMPLANTATION. DURING THE PROCEDURE, A PERICARDIAL TAMPONADE WAS DISCOVERED. CARDIAC SURGEONS INTERVENED EMERGENTLY TO TREAT THE TAM PONADE AND PERFORMED AN AORTIC VALVE REPLACEMENT WITH A SURGICAL VALVE. THE PATIENT DID NOT SURVIVE THE SURGICAL OPERATION. ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE CAUSE OF THE TAMPONADE WAS THE MOVEMENT WITH THE WIRE, AND THE DELIVERY SYSTEM COULD HAVE CONTRIBUTED WHILE TRYING TO POSITION THE VALVE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS AN AORTIC DISSECTION. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT A NON-MEDTRONIC (BOSTON SCIENTIFIC SAFARI) GUIDEWIRE WAS USED FOR THE PROCEDURE.
ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE CAUSE OF THE TAMPONADE WAS THE MOVEMENT WITH THE WIRE, AND THE DELIVERY SYSTEM COULD HAVE CONTRIBUTED WHILE TRYING TO POSITION THE VALVE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS AN AORTIC DISSECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614266 | EVOLUT FX DCS | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC IRELAND | D-EVOLUTFX-2329 | 0013293845 | 00763000944469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |