EVOLUT FX PLUS VALVE
Report
- Report Number
- 9617601-2026-01887
- Event Type
- Malfunction
- Date Received
- March 18, 2026
- Date of Event
- March 12, 2026
- Report Date
- March 27, 2026
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000920449
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPDATED DATA: B5 H6 ADDITIONAL CODES. 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-34 (LOT: 0013142778); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID D-EVOLUTFX-34 (LOT: 0013246844); PRODUCT TYPE: 0195-HEART VALVES. PRODUCT ID EVFXPLUS-34 (K957605); 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 FLUOROSCOPIC MEDIA FILES AND ONE IMAGE WERE PROVIDED FOR REVIEW. REVIEW OF THE VALVE LOAD INSPECTION IDENTIFIED A MISLOAD, CHARACTERIZED BY CROWN OVERLAP EXTENDING TO NODE 4. OVERLAP PRIOR TO NODE 4 IS CONSIDERED A GOOD LOAD; OVERLAP AT NODE 4 AND BEYOND IS CONSIDERED A MISLOAD. AS STATED IN THE INSTRUCTIONS FOR USE, IF A MISLOAD IS DETECTED, DO NOT ATTEMPT TO RELOAD THE BIOPROSTHESIS. THE VALVE, CATHETER, LOADING SYSTEM, LOADING TRAY, AND SALINE MUST ALL BE REPLACED WITH NEW STERILE COMPONENTS. IT WAS REPORTED THAT A MISLOAD WAS IDENTIFIED. DESPITE THE MISLOAD, THE VALVE WAS ATTEMPTED TO BE IMPLANTED WHICH RESULTED IN INFOLDING OBSERVED DURING THE FIRST DEPLOYMENT ATTEMPT. THE INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW. INFOLDING COULD OCCUR DUE TO A MISLOADED VALVE, ANATOMICAL CHARACTERISTICS SUCH AS CALCIUM, AND RECAPTURES. IF AN INFOLD IS IDENTIFIED, THE VALVE SHOULD BE RECAPTURED AND REMOVED FROM THE BODY. NEW STERILE COMPONENTS MUST BE USED. EVIDENCE SUPPORTS THAT THE INFOLDED VALVE WAS WITHDRAWN, AND A NEW VALVE WAS PREPPED, WHICH REVEALED ANOTHER MISLOAD CHARACTERIZED BY CROWN OVERLAP EXTENDING TO NODE 4. DESPITE THE MISLOAD, THE VALVE WAS ATTEMPTED TO BE IMPLANTED WHICH RESULTED IN ANOTHER INFOLD WITH THE NEW VALVE. IT WAS DOCUMENTED THAT A DECISION WAS MADE TO IMPLANT A 29MM EVOLUT INSTEAD. IMAGES OF THE 29MM IMPLANTATION WERE NOT AVAILABLE FOR REVIEW. THE ABSENCE OF THE PATIENT¿S EXECUTIVE SUMMARY LIMITED THE ABILITY TO PERFORM A COMPREHENSIVE ANATOMICAL ASSESSMENT. 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.
ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE FIRST VALVE IMPLANT ATTEMPT, SEVERE CENTRAL AORTIC REGURGITATION WAS OBSERVED. A PROCEDURAL DELAY RESULTED FROM THE VALVE INFOLDS.
IT WAS REPORTED THAT DURING A SCHEDULED TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE USING THE EVOLUT FX+ 34 MILLIMETER (MM) PROSTHESIS, A CROWN OVERLAP UP TO NODE 4 (MISLOAD)WAS DETECTED DURING THE VALVE LOADING PROCESS ON THE FIRST ATTEMPT. THE VALVE WAS LOADED BY AN EXPERIENCED VALVE LOADER. DESPITE THIS, THE PHYSICIAN PROCEEDED WITH THE IMPLANTATION. DURING DEPLOYMENT, THE PROSTHESIS DID NOT EXPAND COMPLETELY AND A VISIBLE INFOLD OF THE FRAME WAS OBSERVED, RESULTING IN VALVULAR REGURGITATION. THE DEVICE WAS RECAPTURED AND REMOVED. FOR THE SECOND ATTEMPT, ANOTHER EVOLUT FX+ 34MM WAS PREPARED, AND A CROWN OVERLAP TO NODE 3-4 WAS AGAIN IDENTIFIED DURING LOADING. THE PHYSICIAN PROCEEDED, AND AN IDENTICAL INFOLD OF THE FRAME OCCURRED DURING DEPLOYMENT, NECESSITATING REMOVAL OF THE DEVICE. THE PATIENT WAS ULTIMATELY TREATED WITH A NON-MEDTRONIC 29MM VALVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693955 | EVOLUT FX PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVFXPLUS-34 | 00763000920449 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |