EVOLUT FX PLUS VALVE
Report
- Report Number
- 9617601-2025-03461
- Event Type
- Malfunction
- Date Received
- December 12, 2025
- Date of Event
- December 8, 2025
- Report Date
- March 9, 2026
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000920432
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IMAGE REVIEW: SIX MEDIA FILES AND ONE STATIC IMAGE WERE SUBMITTED FOR REVIEW. THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT INCLUDED, SO A COMPLETE ANATOMICAL ASSESSMENT COULD NOT BE PERFORMED. FLUOROSCOPIC VALVE LOAD INSPECTION FOR THE FIRST VALVE WAS PERFORMED AND CONFIRMED A GOOD LOAD. DURING THE IMPLANTATION ATTEMPT, UNDER EXPANSION AND A SUSPECTED INFOLD PROMPTED A RECAPTURE. IF A VALVE IS UNDER-EXPANDED, THE SYSTEM SHOULD BE REMOVED, PRE-DILATATION PERFORMED, AND A NEW VALVE IMPLANTED USING A NEW DELIVERY CATHETER SYSTEM (DCS). A NEW VALVE WAS PREPPED, AND FLUOROSCOPIC INSPECTION REVEALED A MISLOAD IDENTIFIED BY MISALIGNED OUTFLOW CROWNS AND NOT PARALLEL TO THE PADDLE ATTACHMENT. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), 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. THE MISLOAD WAS NOT IDENTIFIED AND IT WAS REPORTED THAT DURING THE DEPLOYMENT ATTEMPT OF THE VALVE, A SEPARATION OF THE DCS END CAP OCCURRED. AN END CAP SEPARATION MAY OCCUR WHEN THERE IS SIGNIFICANT AMOUNT OF TENSION BUILDUP WITH THE DCS. THE VALVE AND SYSTEM WERE WITHDR AWN, AND ANOTHER VALVE WAS PREPPED CONFIRMING A GOOD LOAD. THE NEW VALVE WAS SUBSEQUENTLY IMPLANTED, AND FINAL ANGIOGRAM REVEALED AN EXPANDED VALVE WITH NO SIGNIFICANT AORTIC REGURGITATION/PARAVALVULAR LEAK. UPDATED: 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.
UPDATED DATA: D9, H2, H3, H6. PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE VALVE WAS RETURNED LOADED INSIDE THE DELIVERY SYSTEM IN GALWAY. THE VALVE WAS REMOVED FROM THE DELIVERY SYSTEM AND FORWARDED TO THE SANTA ANA RETURN PRODUCT ANALYSIS LAB. THE VALVE WAS RECEIVED IN A HEART VALVE RETURN KIT JAR, FULLY SUBMERGED IN A CLOUDY 0.2% GLUTARALDEHYDE SOLUTION. THE VALVE WAS DISCOLORED, SHOWING EVIDENCE OF BLOOD CONTACT. THE VALVE APPEARS CRIMPED, WITH THE VALVE TISSUE APPEARING DESICCATED. ALL LEAFLETS EXHIBITED SIGNS OF DESICCATION, CREASES, AND FRAME IMPRINTS. THESE CONDITIONS MAY BE ASSOCIATED WITH THE VALVE BEING CRIMPED INSIDE THE CAPSULE OF THE DELIVERY SYSTEM FOR AN UNKNOWN DURATION. THE LEAFLETS WERE STIFF YET SLIGHTLY FLEXIBLE. ALL LEAFLETS APPEAR TO BE IN THE OPEN POSITION. ALL COMMISSURES APPEARED INTACT. NO DAMAGE, SUCH AS BENDS OR KINKS, WAS FOUND ON THE FRAME. THE VALVE WAS SUBMERGED IN BODY-TEMP (APPROXIMATELY 37 °C) SALINE. THE FRAME EXPANDED; HOWEVER, IT RETAINED A COMPRESSED STATE. IT IS POSSIBLE THAT THE COMPRESSED STATE MAY BE ASSOCIATED WITH THE VALVE BEING LOADED INSIDE THE DELIVERY SYSTEM FOR AN UNKNOWN DURATION OF TIME. DUE TO THE RECEIPT CONDITION, A DEPLOYMENT SIMULATION TO EVALUATE AGAINST THE ALLEGED INFOLD EVENT CANNOT BE PERFORMED. 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-2329 (LOT: 0013090417); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID: D-EVOLUTFX-2329 (0012968055); 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: 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 INVOLVING THE TRANSCATHETER AORTIC VALVE EVFXPLUS-29, THE VALVE WAS LOADED BY AN EXPERIENCED VALVE LOADER AND FLUOROSCOPY CHECK REVEALED A GOOD LOAD. THERE WAS UNCERTAINTY REGARDING A VALVE INFOLD AFTER THE VALVE WAS RELEASED TO 80% IN THE AORTIC ANNULUS, WHICH LED TO A DECISION TO RETRIEVE THE VALVE. A NEW VALVE WAS LOADED INTO A NEW DELIVERY SYSTEM, AND AFTER OPENING THE CAPSULE APPROXIMATELY 1 CENTIMETER (CM) IN THE AORTIC ANNULUS, AN ENDCAP SEPARATION OCCURRED. THE SYSTEM WAS RETRIEVED, AND ANOTHER NEW VALVE WAS LOADED INTO A NEW DELIVERY SYSTEM AND IMPLANTED WITHOUT ANY PROBLEMS OR NEGATIVE EFFECTS FOR THE PATIENT. FLUOROSCOPIC CHECKS WERE PERFORMED TWICE, WITH BOTH RESULTS REPORTED AS GOOD LOADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFOLD IN THE VALVE FRAME WAS FIRST NOTICED DURING FIRST DEPLOYMENT. A PROCEDURAL DELAY OF 20-30 MINUTES OCCURRED AS A RESULT OF THE INFOLD FOR THE TWO EXTRALOADINGS. PER THE PHYSICIAN, THE PATIENT'S ANNULAR CALCIFICATION CONTRIBUTED TO THE INFOLD.
IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE PROCEDURE INVOLVING THE TRANSCATHETER AORTIC VALVE EVFXPLUS-29, THE VALVE WAS LOADED BY AN EXPERIENCED VALVE LOADER AND FLUOROSCOPY CHECK REVEALED A GOOD LOAD. THERE WAS UNCERTAINTY REGARDING A VALVE INFOLD AFTER THE VALVE WAS RELEASED TO 80% IN THE AORTIC ANNULUS, WHICH LED TO A DECISION TO RETRIEVE THE VALVE. A NEW VALVE WAS LOADED INTO A NEW DELIVERY SYSTEM, AND AFTER OPENING THE CAPSULE APPROXIMATELY 1 CENTIMETER (CM) IN THE AORTIC ANNULUS, AN ENDCAP SEPARATION OCCURRED. THE SYSTEM WAS RETRIEVED, AND ANOTHER NEW VALVE WAS LOADED INTO A NEW DELIVERY SYSTEM AND IMPLANTED WITHOUT ANY PROBLEMS OR NEGATIVE EFFECTS FOR THE PATIENT. FLUOROSCOPIC CHECKS WERE PERFORMED TWICE, WITH BOTH RESULTS REPORTED AS GOOD LOADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249985 | EVOLUT FX PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVFXPLUS-29 | 00763000920432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SEE H11... |