EVOLUT FX PLUS VALVE
Report
- Report Number
- 9617601-2026-02524
- Event Type
- Malfunction
- Date Received
- April 17, 2026
- Date of Event
- April 14, 2026
- Report Date
- April 23, 2026
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000957353
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID L-EVOLUTFX-2329 (LOT: 0013238842); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0013015535); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0013309717); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVFXPLUS-26 (R250329); 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: B5. 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: A PRE-IMPLANT PATIENT EXECUTIVE SUMMARY WAS NOT PROVIDED; THEREFORE, A COMPREHENSIVE PRE-PROCEDURAL ANATOMICAL ASSESSMENT COULD NOT BE PERFORMED. IT WAS REPORTED THAT THE PATIENT HAD A HEAVILY CALCIFIED AORTIC ANNULUS WITH ASSOCIATED LEFT VENTRICULAR OUTFLOW TRACT CALCIFICATION. NINE INTRAPROCEDURAL FLUOROSCOPIC MEDIA FILES AND ELEVEN STILL IMAGES WERE SUBMITTED FOR REVIEW. REVIEW OF THE AVAILABLE IMAGING INDICATES THAT AN ALTERNATIVE ACCESS ROUTE WAS UTILIZED FOR THE TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE. FLUOROSCOPIC INSPECTION OF THE FIRST VALVE DURING LOADING DEMONSTRATED NO EVIDENCE OF MISLOAD. A PRE-BALLOON AORTIC VALVULOPLASTY WAS PERFORMED PRIOR TO THE INITIAL VALVE IMPLANTATION ATTEMPT. DURING THE IMPLANTATION ATTEMPT, SIGNIFICANT VALVE UNDER EXPANSION WITH A POSSIBLE INFOLD WAS OBSERVED. ACCORDING TO MEDTRONIC BEST PRACTICES, UNDER-EXPANSION SHOULD PROMPT REMOVAL OF THE DELIVERY SYSTEM, PRE-DILATATION, AND IMPLANTATION OF A NEW VALVE USING A NEW DELIVERY SYSTEM. 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. 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. IT WAS REPORTED THAT THE UNDER EXPANDED VALVE WAS WITHDRAWN. A SECOND VALVE WAS SUBSEQUENTLY PREPARED, AND FLUOROSCOPIC INSPECTION DEMONSTRATED AN ACCEPTABLE LOAD. A REPEAT PRE-BALLOON AORTIC VALVULOPLASTY WAS PERFORMED PRIOR TO THE IMPLANTATION ATTEMPT WITH THE SECOND VALVE. DURING THE IMPLANTATION ATTEMPT OF THE SECOND VALVE, SIGNIFICANT UNDER EXPANSION WAS AGAIN OBSERVED. AT LEAST ONE RECAPTURE WAS PERFORMED, AND PERSISTENT UNDER EXPANSION WAS NOTED DURING A SUBSEQUENT DEPLOYMENT ATTEMPT. DOCUMENTATION INDICATES THAT THE VALVE WAS WITHDRAWN, AND AN ADDITIONAL PRE-BALLOON AORTIC VALVULOPLASTY WAS PERFORMED. A THIRD VALVE WAS REPORTEDLY PREPARED AND SUCCESSFULLY IMPLANTED, WITH NO EVIDENCE OF AORTIC REGURGITATION OBSERVED ON THE AVAILABLE IMAGING. IMAGES OF THE UNDEPLOYED VALVES WERE AVAILABLE AND DEMONSTRATED UNCONSTRAINED FRAMES. ONE VALVE WAS DEPLOYED ON THE STERILE FIELD, AND IMAGING SHOWED A POSSIBLE CALCIFIC FRAGMENT ATTACHED TO THE VALVE FRAME. UPDATED B.5 AND 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 PROCEDURE, THE PATIENT HAD A CALCIUM SCORE OF 3500 WITH A HEAVILY CALCIFIED ANNULUS AND LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. FLUOROSCOPY CHECK WAS PERFORMED AND NOTED AN OVERLAP TO NODE 2.5. THE ANNULUS WAS PRE-DILATED WITH A 20 MM NON-MEDTRONIC BALLOON. THE VALVE WAS INSERTED AND, AT APPROXIMATELY 80% DEPLOYMENT, THE VALVE APPEARED CONSTRAINED. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE RECAPTURED AND REMOVED. THE ANNULUS WAS PRE-DILATED AGAIN WITH THE SAME 20 MM NON-MEDTRONIC BALLOON WITH THE WIDEST PORTION OF THE BALLOON AT THE ANNULUS LEVEL, AND A SECOND TRANSCATHETER AORTIC VALVE WAS INSERTED. AT APPROXIMATELY 80% DEPLOYMENT, THE VALVE CONTINUED TO LOOK CONSTRAINED AND THE VALVE WAS RECAPTURED AND REMOVED. THE ANNULUS WAS THEN DILATED WITH A DIFFERENT 22 MM NON-MEDTRONIC BALLOON, AND A THIRD VALVE WAS INSERTED AND SUCCESSFULLY IMPLANTED. THE PATIENT EXPERIENCED RAPID PACING WITH EACH ANNULUS DILATATION.
IT WAS REPORTED THAT, DURING A TRANSCATHETER AORTIC VALVE PROCEDURE, THE PATIENT HAD A CALCIUM SCORE OF 3500 WITH A HEAVILY CALCIFIED ANNULUS AND LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. FLUOROSCOPY CHECK WAS PERFORMED AND NOTED AN OVERLAP TO NODE 2.5. THE ANNULUS WAS PRE-DILATED WITH A 20 MM NON-MEDTRONIC BALLOON. THE VALVE WAS INSERTED AND, AT APPROXIMATELY 80% DEPLOYMENT, THE VALVE APPEAREDCONSTRAINED. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE RECAPTURED AND REMOVED. THE ANNULUS WAS PRE-DILATED AGAIN WITH THE SAME 20 MM NON-MEDTRONIC BALLOON WITH THE WIDEST PORTION OF THE BALLOON AT THE ANNULUS LEVEL, AND A SECOND TRANSCATHETER AORTIC VALVE WAS INSERTED. AT APPROXIMATELY 80% DEPLOYMENT, THE VALVE CONTINUED TO LOOK CONSTRAINED AND THE VALVE WAS RECAPTURED AND REMOVED. THE ANNULUS WAS THEN DILATED WITH A DIFFERENT 22 MM NON-MEDTRONIC BALLOON, AND A THIRD VALVE WAS INSERTED AND SUCCESSFULLY IMPLANTED. THE PATIENT EXPERIENCED RAPID PACING WITH EACH ANNULUS DILATATION. ADDITIONAL INFORMATION WAS RECEIVED THAT AN INFOLD OCCURRED AFTER THE VALVE WAS RECAPTURED. A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD TO PREPARE A NEW VALVE. PER THE PHYSICIAN, THE PATIENT'S SEVERE AORTIC CALCIFICATION CONTRIBUTED TO THE INFOLD. THE SECOND VALVE ALSO INFOLDED FOLLOWING RECAPTURE AND A PROCEDURAL DELAY OCCURRED AS A RESULT OF PREPARING ANOTHER VALVE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TWO VALVES WERE RECAPTURED DUE TO APPEARING CONSTRAINED AT 80% WHICH THE PHYSICIAN ATTRIBUTED TO THE NON-MEDTRONIC BALLOON PRE-DILATATIONS BEING INSUFFICIENT IN PREPARING THE ANNULUS.
ADDITIONAL INFORMATION WAS RECEIVED THAT AN INFOLD OCCURRED AFTER THE VALVE WAS RECAPTURED. A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD TO PREPARE A NEW VALVE. PER THE PHYSICIAN, THE PATIENT'S SEVERE AORTIC CALCIFICATION CONTRIBUTED TO THE INFOLD. THE SECOND VALVE ALSO INFOLDED FOLLOWING RECAPTURE AND A PROCEDURAL DELAY OCCURRED AS A RESULT OF PREPARING ANOTHER VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459649 | EVOLUT FX PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVFXPLUS-26 | 00763000957353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |