EVOLUT FX PLUS VALVE
Report
- Report Number
- 9617601-2025-01490
- Event Type
- Malfunction
- Date Received
- September 17, 2025
- Date of Event
- September 10, 2025
- Report Date
- December 19, 2025
- 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
CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-34 (LOT: 0012864346); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE; EXPLANT DATE PRODUCT ID L-EVOLUTFX-34 (LOT: 0012914429); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012760082); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID L-EVOLUTFX-2329 (LOT: 0012964910); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID EVFXPLUS-29 (K946598); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; EXPLANT DATE 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.
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. THE VALVE APPEARS SLIGHTLY 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 CR IMPED 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 OUTFLOW AND INFLOW DISPLAYED AN ELLIPTICAL APPEARANCE. 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. UPDATED H.6 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.
UPDATE TO IMAGE REVIEW: SEVEN IMAGES FROM THE PATIENT¿S EXECUTIVE SUMMARY WERE PROVIDED FOR ANATOMICAL REVIEW. PATIENT APPEARED TO HAVE A SIGNIFICANTLY CALCIFIED POSSIBLE TYPE 1 BICUSPID AORTIC VALVE WITH AN ANNULUS PERIMETER THAT MEASURED 85.9MM WITH A PERIMETER DERIVED DIAMETER OF 27.4MM SUGGESTING A 34MM EVOLUT. 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: 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.
IMAGE REVIEW: THIRTY MEDIA FILES WERE PROVIDED FOR REVIEW. PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. HOWEVER, IT IS KNOWN THAT THE PATIENT HAD A BICUSPID VALVE WITH AN ANNULUS PERIMETER THAT MEASURED 86MM SUGGESTING A 34MM EVOLUT. FLUOROSCOPY VALVE LOAD INSPECTION WAS PERFORMED AND CONFIRMED A GOOD LOAD. A PRE BALLOON AORTIC VALVULOPLASTY WAS PERFORMED PRIOR TO THE VALVE IMPLANT. THE VALVE WAS PARTIALLY DEPLOYED AND APPEARED TO BE SIGNIFICANTLY UNDER EXPANDED. PER MEDTRONIC BEST PRACTICES, IF A VALVE IS UNDER-EXPANDED: REMOVE SYSTEM, PERFORM PRE-DILATATION, AND IMPLANT NEW VALVE WITH NEW DELIVERY SYSTEM. THE VALVE WAS RECAPTURED AND DURING THE SUBSEQUENT DEPLOYMENT ATTEMPT, AN INFOLD OCCURRED. THE INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW. INFOLDING COULD OCCUR DUE A MISLOADED VALVE, ANATOMICAL CHARACTERISTICS SUCH AS CALCIUM, AND RECAPTURES. ACCORDING TO MEDTRONIC BEST PRACTICES, IF AN INFOLD IS IDENTIFIED, THE VALVE SHOULD BE RECAPTURED, REMOVED FROM THE BODY, AND DISCARDED. NEW STERILE COMPONENTS MUST BE USED. EVIDENCE SUPPORTS THAT THE INFOLDED VALVE WAS RECAPTURED, AND A NEW VALVE (REPORTEDLY A 29MM) WAS LOADED AND CONFIRMED A GOOD LOAD. ANOTHER PRE BALLOON AORTIC VALVULOPLASTY WAS PERFORMED. THE NEW VALVE WAS IMPLANTED WITHOUT ANY FURTHER ISSUES WITH UNDER EXPANSION AND INFOLDING BUT THERE WAS EVIDENCE OF MODERATE AORTIC REGURGITATION/PARAVALVULAR LEAK. A POST IMPLANT DILATATION WAS PERFORMED. IT WAS REPORTED THAT MILD PARAVALVULAR LEAK REMAINED AFTER THE POST IMPLANT DILATATION. UPDATED H.6 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 IMPLANTATION PROCEDURE, A 34 FX+ VALVE WAS SELECTED FOR A PATIENT WITH AN ANNULUS PERIMETER OF 86MM AND A BICUSPID VALVE TYPE I. PRE-DILATION WAS PERFORMED WITH A 22MM BALLOON VIA A NON-MEDTRONIC GUIDEWIRE. THE VALVE WAS LOADED AND CONFIRMED BY FLUOROSCOPIC INSPECTION. DURING THE FIRST ATTEMPT AT IMPLANTATION USING THE CUSP OVERLAP TECHNIQUE, UNDER-EXPANSION OF THE VALVE WAS OBSERVED, LEADING TO A RECAPTURE. ON THE SECOND ATTEMPT, THE VALVE WAS IMPLANTED AT 1MM NON-CORONARY CUSP (NCC), WHICH WAS CONSIDERED TOO HIGH, AND UNDER-EXPANSION WAS AGAIN NOTED, RESULTING IN A SECOND RECAPTURE. DURING THE THIRD DEPLOYMENT ATTEMPT, AN INFOLD OF THE VALVE WAS NOTICED, AND THE VALVE WAS RECAPTURED AND RETRIEVED FROM THE PATIENT. A BALLOON DILATION WAS PERFORMED WITH A 24MM BALLOON. THE DECISION WAS MADE TO UTILIZE A 29MM EVOLUT VALVE, WHICH WAS PROPERLY LOADED AND CONFIRMED BY FLUOROSCOPIC INSPECTION. THE VALVE WAS SUCCESSFULLY IMPLANTED. NO GRADIENTS WERE MEASURED, BUT ANGIOGRAPHIC ASSESSMENT REVEALED MODERATE PARAVALVULAR LEAK (PVL). A POST-BALLOON AORTIC VALVULOPLASTY WITH A 24MM BALLOON WAS PERFORMED, AFTER WHICH MILD PVL REMAINED. .
IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, A 34 FX+ VALVE WAS SELECTED FOR A PATIENT WITH AN ANNULUS PERIMETER OF 86MM AND A BICUSPID VALVE TYPE I. PRE-DILATION WAS PERFORMED WITH A 22MM BALLOON VIA A NON-MEDTRONIC GUIDEWIRE. THE VALVE WAS LOADED AND CONFIRMED BY FLUOROSCOPIC INSPECTION. DURING THE FIRST ATTEMPT AT IMPLANTATION USING THE CUSP OVERLAP TECHNIQUE, UNDER-EXPANSION OF THE VALVE WAS OBSERVED, LEADING TO A RECAPTURE. ON THE SECOND ATTEMPT, THE VALVE WAS IMPLANTED AT 1MM NON-CORONARY CUSP (NCC), WHICH WAS CONSIDERED TOO HIGH, AND UNDER-EXPANSION WAS AGAIN NOTED, RESULTING IN A SECOND RECAPTURE. DURING THE THIRD DEPLOYMENT ATTEMPT, AN INFOLD OF THE VALVE WAS NOTICED, AND THE VALVE WAS RECAPTURED AND RETRIEVED FROM THE PATIENT. A BALLOON DILATION WAS PERFORMED WITH A 24MM BALLOON. THE DECISION WAS MADE TO UTILIZE A 29MM EVOLUT VALVE, WHICH WAS PROPERLY LOADED AND CONFIRMED BY FLUOROSCOPIC INSPECTION. THE VALVE WAS SUCCESSFULLY IMPLANTED. NO GRADIENTS WERE MEASURED, BUT ANGIOGRAPHIC ASSESSMENT REVEALED MODERATE PARAVALVULAR LEAK (PVL). A POST-BALLOON AORTIC VALVULOPLASTY WITH A 24MM BALLOON WAS PERFORMED, AFTER WHICH MILD PVL REMAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT A DELAY OF THE PROCEDURE OCCURRED AS A RESULT OF THE INFOLD DUE TO NEW VALVE LOADING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2504123 | 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 | 84 YR | Male |