EVOLUT FX PLUS VALVE
Report
- Report Number
- 9617601-2026-01133
- Event Type
- Death
- Date Received
- February 11, 2026
- Date of Event
- February 4, 2026
- Report Date
- April 24, 2026
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000920432
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
UPDATED DATA: B1, B2, B5, H1, H6. H11. THIS IS A SYSTEM REPORT. THE SECTION D. INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING DEVICE(S) WHICH CANNOT BE EXCLUDED AS POTENTIAL CONTRIBUTING FACTORS TO THE ADVERSE EVENT: BRAND NAME: DELIV SYS D-EVOLUTFX-2329; PRODUCT ID: D-EVOLUTFX-2329; SERIAL/LOT: (B)(6); MANUFACTURED DATE: 2025-11-12; USE BY DATE: 2027-11-12; THE CODES PRESENT IN SECTION H6. CORRESPOND TO MULTIPLE COMPONENTS/PRODUCTS THAT COMPRISE THIS REPORTED EVENT. 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.
UPDATED DATA: B2, 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: B2, B5, H6, H10. 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-2329; PRODUCT LOT/SERIAL NUMBER (B)(6); PRODUCT TYPE: HEART VALVES; IMPLANT DATE NA; EXPLANT DATE NA 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: ONE MEDIA FILE WAS PROVIDED FOR REVIEW. THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT AVAILABLE, WHICH LIMITED THE ABILITY TO PERFORM A COMPREHENSIVE ANATOMICAL ASSESSMENT. HOWEVER, IT WAS DOCUMENTED THAT THE PATIENT HAD A BICUSPID AORTIC VALVE, AND A PRE- IMPLANT BALLOON DILATION WAS PERFORMED. A FLUOROSCOPIC VALVE LOAD INSPECTION WAS NOT PROVIDED FOR REVIEW THUS IT IS NOT POSSIBLE TO VALIDATE A GOOD LOAD. THE IMAGE RECEIVED SHOWS THAT DURING THE IMPLANTATION ATTEMPT, AN INFOLD WAS OBSERVED. 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, REMOVED FROM THE BODY, AND NOT USED. IT WAS REPORTED THAT A NEW SYSTEM WAS USED. SINCE FLUOROSCOPIC VALVE LOAD INSPECTION WAS NOT PROVIDED, IT IS NOT POSSIBLE TO RULE OUT THAT A POSSIBLE MISLOAD MIGHT HAVE CONTRIBUTED TO THE INFOLD. 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.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS RECAPTURED BECAUSE IT WAS TOO DEEP ON THE LEFT CORONARY CUSP (LCC). THE LEFT SUBCLAVIAN APPROACH WAS USED FOR THE PROCEDURE. THE INFOLD WAS FIRST OBSERVED AFTER THE SECOND DEPLOYMENT ATTEMPT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A SEVERE STROKE AND SUBSEQUENTLY DIED.
IT WAS REPORTED THAT DURING DEPLOYMENT OF THE TRANSCATHETER AORTIC VALVE EVFXPLUS-29, AN INFOLD WAS DETECTED. THE PATIENT HAD A MEDICAL HISTORY OF SEVERE SYMPTOMATIC LOW-FLOW, LOW GRADIENT AORTIC STENOSIS, ATRIAL FIBRILLATION, ARTERIAL HYPERTENSION, DIABETES MELLITUS TYPE II, AMYLOIDOSIS, ASYMPTOMATIC PERIPHERAL ARTERIAL VASCULAR DISEASE, BICUSPID AORTIC VALVE, AND LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. X-RAY IMAGING WAS CONDUCTED TO ASSESS THE VALVE LOAD, AND NO INFOLD WAS SEEN AT THAT POINT. PREDILATATION WAS PERFORMED ACCORDING TO MINIMUM DIAMETER DUE TO THE PRESENCE OF LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. THE VALVE WAS DEPLOYED TO 80% WHEN THEINFOLD WAS DETECTED; THE SYSTEM WAS RETRIEVED AND REPLACED WITH A NEW VALVE AND DELIVERY SYSTEM, WHICH WAS SUCCESSFULLY USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS RECAPTURED THREE TIMES. A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD. PER THE PHYSICIAN, THE PATIENT'S BICUSPID VALVE AND THE USE OF SUBCLAVIAN ACCESS, WHICH MADE COMMISSURAL ALIGNMENT HARD TO ACHIEVE BECAUSE OF THE ANGLE, CONTRIBUTED TO THE INFOLD. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS RECAPTURED BECAUSE IT WAS TOO DEEP ON THE LEFT CORONARY CUSP (LCC). THE LEFT SUBCLAVIANAPPROACH WAS USED FOR THE PROCEDURE. THE INFOLD WAS FIRST OBSERVED AFTER THE SECOND DEPLOYMENT ATTEMPT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A SEVERE STROKE AND SUBSEQUENTLY DIED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE STROKE OCCURRED THE DAY OF THE IMPLANT PROCEDURE AND SYMPTOMS PRESENTED RIGHT AFTER THE PATIENT WOKE UP. THE STROKE WAS CONFIRMED WITH NEUROLOGICAL ASSESSMENT AFTER NARCOSIS. HALF PARALYSIS OCCURRED BUT IT WAS UNKNOWN WHETHER PERMANENT IMPAIRMENT RESULTED FROM THE STROKE. PER THE PHYSICIAN, IT WAS UNKNOWN WHETHER THE STROKE WAS RELATED TO THE FIRST DELIVERY CATHETER SYSTEM (DCS) AS THE PATIENT HAD GENERAL ANESTHESIA, BUT IT WAS NOT THOUGHT THE STROKE WAS RELATED TO THE FIRST VALVE. THE PHYSICIAN INDICATED THE STROKE MAY HAVE BEEN RELATED TO THE SECOND DCS WITH THE CHANGE OF THE DEVICE AND UNCLEAR WHETHER RELATED TO THE SECOND VALVE, AS IT COULD HAVE BEEN FROM THE CHANGE OF DEVICES IN AND OUT. THERE WAS NOT MUCH TREATMENT FOR THE STROKE AS THE PATIENT WAS ALREADY VERY OLD. CALCIFIED ANATOMY WAS A CONTRIBUTING FACTOR TO THE STROKE. THE DEATH OCCURRED SOME DAYS LATER AND WAS DUE TO THE STROKE PER THE PHYSICIAN. THE PHYSICIAN DID NOT KNOW WHETHER THE FIRST VALVE CONTRIBUTED TO THE DEATH AND INDICATED THE SECOND VALVE MAY HAVE CONTRIBUTED BECAUSE OF THE IN AND OUTOF THE DEVICE. THE VALVE WAS EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SECOND VALVE WAS NOT EXPLANTED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DIED 1 DAY FOLLOWING THE PROCEDURE.
IT WAS REPORTED THAT DURING DEPLOYMENT OF THE TRANSCATHETER AORTIC VALVE EVFXPLUS-29, AN INFOLD WAS DETECTED. THE PATIENT HAD A MEDICAL HISTORY OF SEVERE SYMPTOMATIC LOW-FLOW, LOW GRADIENT AORTIC STENOSIS, ATRIAL FIBRILLATION, ARTERIAL HYPERTENSION, DIABETES MELLITUS TYPE II, AMYLOIDOSIS, ASYMPTOMATIC PERIPHERAL ARTERIAL VASCULAR DISEASE, BICUSPID AORTIC VALVE, AND LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. X-RAY IMAGING WAS CONDUCTED TO ASSESS THE VALVE LOAD, AND NO INFOLD WAS SEEN AT THAT POINT. PREDILATATION WAS PERFORMED ACCORDING TO MINIMUM DIAMETER DUE TO THE PRESENCE OF LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. THE VALVE WAS DEPLOYED TO 80% WHEN THE INFOLD WAS DETECTED; THE SYSTEM WAS RETRIEVED AND REPLACED WITH A NEW VALVE AND DELIVERY SYSTEM, WHICH WAS SUCCESSFULLY USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS RECAPTURED THREE TIMES. A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD. PER THE PHYSICIAN, THE PATIENT'S BICUSPID VALVE AND THE USE OF SUBCLAVIAN ACCESS, WHICH MADE COMMISSURAL ALIGNMENT HARD TO ACHIEVE BECAUSE OF THE ANGLE, CONTRIBUTED TO THE INFOLD. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS RECAPTURED BECAUSE IT WAS TOO DEEP ON THE LEFT CORONARY CUSP (LCC). THE LEFT SUBCLAVIAN APPROACH WAS USED FOR THE PROCEDURE. THE INFOLD WAS FIRST OBSERVED AFTER THE SECOND DEPLOYMENT ATTEMPT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A SEVERE STROKE AND SUBSEQUENTLY DIED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE STROKE OCCURRED THE DAY OF THE IMPLANT PROCEDURE AND SYMPTOMS PRESENTED RIGHT AFTER THE PATIENT WOKE UP. THE STROKE WAS CONFIRMED WITH NEUROLOGICAL ASSESSMENT AFTER NARCOSIS. HALF PARALYSIS OCCURRED BUT IT WAS UNKNOWN WHETHER PERMANENT IMPAIRMENT RESULTED FROM THE STROKE. PER THE PHYSICIAN, IT WAS UNKNOWN WHETHER THE STROKE WAS RELATED TO THE FIRST DELIVERY CATHETER SYSTEM (DCS) AS THE PATIENT HAD GENERAL ANESTHESIA, BUT IT WAS NOT THOUGHT THE STROKE WAS RELATED TO THE FIRST VALVE. THE PHYSICIAN INDICATED THE STROKE MAY HAVE BEEN RELATED TO THE SECOND DCS WITH THE CHANGE OF THE DEVICE AND UNCLEAR WHETHER RELATED TO THE SECOND VALVE, AS IT COULD HAVE BEEN FROM THE CHANGE OF DEVICES IN AND OUT. THERE WAS NOT MUCH TREATMENT FOR THE STROKE AS THE PATIENT WAS ALREADY VERY OLD. CALCIFIED ANATOMY WAS A CONTRIBUTING FACTOR TO THE STROKE. THE DEATH OCCURRED SOME DAYS LATER AND WAS DUE TO THE STROKE PER THE PHYSICIAN. THE PHYSICIAN DID NOT KNOW WHETHER THE FIRST VALVE CONTRIBUTED TO THE DEATH AND INDICATED THE SECOND VALVE MAY HAVE CONTRIBUTED BECAUSE OF THE IN AND OUT OF THE DEVICE. THE VALVE WAS EXPLANTED.
IT WAS REPORTED THAT DURING DEPLOYMENT OF THE TRANSCATHETER AORTIC VALVE EVFXPLUS-29, AN INFOLD WAS DETECTED. THE PATIENT HAD A MEDICAL HISTORY OF SEVERE SYMPTOMATIC LOW-FLOW, LOW GRADIENT AORTIC STENOSIS, ATRIAL FIBRILLATION, ARTERIAL HYPERTENSION, DIABETES MELLITUS TYPE II, AMYLOIDOSIS, ASYMPTOMATIC PERIPHERAL ARTERIAL VASCULAR DISEASE, BICUSPID AORTIC VALVE, AND LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. X-RAY IMAGING WAS CONDUCTED TO ASSESS THE VALVE LOAD, AND NO INFOLD WAS SEEN AT THAT POINT. PREDILATATION WAS PERFORMED ACCORDING TO MINIMUM DIAMETER DUE TO THE PRESENCE OF LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. THE VALVE WAS DEPLOYED TO 80% WHEN THE INFOLD WAS DETECTED; THE SYSTEM WAS RETRIEVED AND REPLACED WITH A NEW VALVE AND DELIVERY SYSTEM, WHICH WAS SUCCESSFULLY USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT DURING DEPLOYMENT OF THE TRANSCATHETER AORTIC VALVE EVFXPLUS-29, AN INFOLD WAS DETECTED. THE PATIENT HAD A MEDICAL HISTORY OF SEVERE SYMPTOMATIC LOW-FLOW, LOW GRADIENT AORTIC STENOSIS, ATRIAL FIBRILLATION, ARTERIAL HYPERTENSION, DIABETES MELLITUS TYPE II, AMYLOIDOSIS, ASYMPTOMATIC PERIPHERAL ARTERIAL VASCULAR DISEASE, BICUSPID AORTIC VALVE, AND LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. X-RAY IMAGING WAS CONDUCTED TO ASSESS THE VALVE LOAD, AND NO INFOLD WAS SEEN AT THAT POINT. PREDILATATION WAS PERFORMED ACCORDING TO MINIMUM DIAMETER DUE TO THE PRESENCE OF LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. THE VALVE WAS DEPLOYED TO 80% WHEN THE INFOLD WAS DETECTED; THE SYSTEM WAS RETRIEVED AND REPLACED WITH A NEW VALVE AND DELIVERY SYSTEM, WHICH WAS SUCCESSFULLY USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS RECAPTURED THREE TIMES. A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD. PER THE PHYSICIAN, THE PATIENT'S BICUSPID VALVE AND THE USE OF SUBCLAVIAN ACCESS, WHICH MADE COMMISSURAL ALIGNMENT HARD TO ACHIEVE BECAUSE OF THE ANGLE, CONTRIBUTED TO THE INFOLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100775 | 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 | 89 YR | Male | Required Intervention| S| D | SEE H11 |