EVOLUT FX DCS
Report
- Report Number
- 9612164-2025-05413
- Event Type
- Injury
- Date Received
- November 4, 2025
- Date of Event
- October 28, 2025
- Report Date
- December 18, 2025
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NPT
- UDI-DI
- 00763000365721
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPDATED: B5, E1. 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 {EVFXPLUS-34}; PRODUCT LOT/SERIAL NUMBER {K948074}; PRODUCT TYPE: {0195-HEART VALVES}; IMPLANT DATE (B)(6) 2025; EXPLANT DATE {N/A} PRODUCT ID {NON-MEDTRONIC PROGLIDE}; PRODUCT LOT/SERIAL NUMBER {UNKNOWN}; PRODUCT TYPE: {CLOSURE DEVICE}; IMPLANT DATE {N/A}; EXPLANT DATE {N/A} PRODUCT ID {NON-MEDTRONIC INTRODUCER SHEATHS}; PRODUCT LOT/SERIAL NUMBER {UNKNOWN}; PRODUCT TYPE: {EXTERNAL SHEATHS}; IMPLANT DATE {N/A}; EXPLANT DATE {N/A} 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: 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 AORTIC VALVE PROCEDURE, A 16 FRENCH (FR) INTRODUCER SHEATH WAS INITIALLY USED AND ADVANCED WITHOUT ISSUE. SUBSEQUENTLY, THE DELIVERY CATHETER SYSTEM (DCS) WOULD NOT ADVANCE PAST A TORTUOUS VESSEL. THE SYSTEM WAS REMOVED AND A NON-MEDTRONIC SHEATH WAS POSITIONED; HOWEVER, THE DCS STILL WOULD NOT ADVANCE. A NON-MEDTRONIC (LUNDERQUIST) GUIDEWIRE AND A 22 FR NON-MEDTRONIC (GORE) SHEATH WERE ATTEMPTED BUT COULD NOT PASS. BALLOONING WAS PERFORMED TO ADDRESS THE STENOSIS IN THE TORTUOUS VESSEL, AFTER WHICH THE NON-MEDTRONIC SHEATH ADVANCED SUCCESSFULLY AND THE VALVE WAS DEPLOYED. IT WAS NOTED THAT THE NON-MEDTRONIC (PERCLOSE) CLOSURE DEVICE FAILED TO DEPLOY DUE TO A FOOT PLATE ISSUE. AT THE END OF THE PROCEDURE, A TEAR IN THE ARTERY AT THE ACCESS SITE WAS OBSERVED. SUBSEQUENTLY, A COVERED STENT WAS PLACED. ADDITIONAL INFORMATION WAS RECEIVED THAT RIGHT SIDE ACCESS WAS USED FOR THE PROCEDURE WHICH WAS THE SAME SIDE AS THE DISSECTION. THE PHYSICIAN ATTRIBUTED THE CAUSE OF THE DISSECTION TO THE NON-MEDTRONIC CLOSURE DEVICE AND NOT THE DCS. THE PATIENT'S TORTUOUS ANATOMY WAS A CONTRIBUTING FACTOR TO THE EVENT.
IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE PROCEDURE, A 16 FRENCH (FR) INTRODUCER SHEATH WAS INITIALLY USED AND ADVANCED WITHOUT ISSUE. SUBSEQUENTLY, THE DELIVERY CATHETER SYSTEM (DCS) WOULD NOT ADVANCE PAST A TORTUOUS VESSEL. THE SYSTEM WAS REMOVED AND A NON-MEDTRONIC SHEATH WAS POSITIONED; HOWEVER, THE DCS STILL WOULD NOT ADVANCE. A NON-MEDTRONIC GUIDEWIRE AND A 22 FR NON-MEDTRONIC SHEATH WERE ATTEMPTED BUT COULD NOT PASS. BALLOONING WAS PERFORMED TO ADDRESS THE STENOSIS IN THE TORTUOUS VESSEL, AFTER WHICH THE NON-MEDTRONIC SHEATH ADVANCED SUCCESSFULLY AND THE VALVE WAS DEPLOYED. IT WAS NOTED THAT THE NON-MEDTRONIC CLOSURE DEVICE FAILED TO DEPLOY DUE TO A FOOT PLATE ISSUE. AT THE END OF THE PROCEDURE, A TEAR IN THE ARTERY AT THE ACCESS SITE WAS OBSERVED. SUBSEQUENTLY, A COVERED STENT WAS PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1841122 | EVOLUT FX DCS | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC IRELAND | D-EVOLUTFX-34 | 0012708380 | 00763000365721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |