EVOLUT FX PLUS VALVE
Report
- Report Number
- 2025587-2025-04912
- Event Type
- Malfunction
- Date Received
- July 10, 2025
- Date of Event
- June 24, 2025
- Report Date
- November 21, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- UDI-DI
- 00763000716158
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-34 (LOT: 0012294210); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID D-EVOLUTFX-34 (LOT: 0012294210); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVFXPLUS-34 (K066228); PRODUCT TYPE: 0195-HEART VALVES; 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.
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 VIDEO CLIP OF A ONE SECOND CARDIAC CYCLE PROVIDED. NO DICOM IMAGING PROVIDED. THE ECHOCARDIOGRAM IMAGE SHOWS DAMAGE TO THE NATIVE ATRIO-VENTRICULAR (AV) LEAFLETS. THIS IMAGE COULD BE FROM THE FIRST BALLOON AORTIC VALVULOPLASTY (BAV) OR AFTER THE TWO EVOLUT RECAPTURES AND SECOND BAV (MOST LIKELY). YOU CAN SEE PROLAPSING OF THE NON-CORONARY CUSP (NCC) LEAFLET IN THIS SYSTOLIC FRAME AND PROBABLY MILD MITRAL REGURGITATION. A LOT OF TURBULENCE JUST BEFORE AND AFTER THE AV IN SYSTOLE SUGGESTING AORTIC STENOSIS. PATIENT APPEARS TO HAVE A SIGMOID SEPTUM. UNABLE TO SEE WHAT THE COLOR FLOW DOPPLER SCALE WAS SET TO. IN DIASTOLE THERE APPEARS TO BE SEVERE AORTIC INSUFFICIENCY DUE TO THE DAMAGED AV LEAFLETS FROM THE PRE-BAV. 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: B5 H8. 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.
UPDATED DATA: B5. A THIRD PARAGRAPH WAS ADDED. H6. CORRECTED DATA: 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.
IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOP LASTY (BAV) WAS PERFORMED DUE TO CALCIFICATION AND A BICUSPID AORTIC VALVE. FOLLOWING INITIAL DEPLOYMENT, THE VALVE WAS RECAPTURED DUE TO UNDER-EXPANSION OF THE VALVE FRAME. THE EXPANSION ISSUE WAS ATTRIBUTED TO THE PATIENT'S BICUSPID AORTIC VALVE. UPON A SECOND D EPLOYMENT ATTEMPT TO A DEPTH OF 3 MM, AN INFOLD WAS OBSERVED IN THE VALVE FRAME. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. ANOTHER BAV WAS PERFORMED USING A 25 MM NON-MEDTRONIC BALLOON. A NEW VALVE WAS LOADED INTO A NEW DELIVERY CATHE TER SYSTEM; HOWEVER, THIS VALVE WAS ALSO NOT IMPLANTED IN THE PATIENT. THE DECISION WAS MADE TO IMPLANT A SURGICAL AORTIC VALVE IN THE PATIENT INSTEAD. THERE WAS A 20-MINUTE PROCEDURAL DELAY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE VALVE PROCEDURE, NO MISLOAD WAS OBSERVED DURING LOADING OF THE FIRST VALVE. DURING THE IMPLANT ATTEMPT OF THE SECOND VALVE, AS THE VALVE WAS BEING DEPLOYED, NO MATTER THE DEPTH ON THE NON-CORONARY CUSP (NCC), THE IMPLANTING TEAM KEPT MISSING THE LEFT CORONARY CUSP (LCC) WITH THE VALVE.
IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOP LASTY (BAV) WAS PERFORMED DUE TO CALCIFICATION AND A BICUSPID AORTIC VALVE. FOLLOWING INITIAL DEPLOYMENT, THE VALVE WAS RECAPTURED DUE TO UNDER-EXPANSION OF THE VALVE FRAME. THE EXPANSION ISSUE WAS ATTRIBUTED TO THE PATIENT'S BICUSPID AORTIC VALVE. UPON A SECOND DEPLOYMENT ATTEMPT TO A DEPTH OF 3 MM, AN INFOLD WAS OBSERVED IN THE VALVE FRAME. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. ANOTHER BAV WAS PERFORMED USING A 25 MM NON-MEDTRONIC BALLOON. A NEW VALVE WAS LOADED INTO A NEW DELIVERY CATHE TER SYSTEM; HOWEVER, THIS VALVE WAS ALSO NOT IMPLANTED IN THE PATIENT. THE DECISION WAS MADE TO IMPLANT A SURGICAL AORTIC VALVE IN THE PATIENT INSTEAD. THERE WAS A 20-MINUTE PROCEDURAL DELAY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE VALVE PROCEDURE, NO MISLOAD WAS OBSERVED DURING LOADING OF THE FIRST VALVE. DURING THE IMPLANT ATTEMPT OF THE SECOND VALVE, AS THE VALVE WAS BEING DEPLOYED, NO MATTER THE DEPTH ON THE NON-CORONARY CUSP (NCC), THE IMPLANTING TEAM KEPT MISSING THE LEFT CORONARY CUSP (LCC) WITH THE VALVE. ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY DIFFICULTY WAS NOTED DURING THE ATTEMPTED DEPLOYMENT OF THE SECOND VALVE, WHEN THE VALVE FRAME "WAS ¿FLOWERING¿ OR BEING DEPLOYED, IT KEPT MISSING THE LCC. EVEN WITH MULTIPLE RECAPTURES AND DEPTH ADJUSTMENTS ON THE NCC." THE VALVE FRAME WAS UNDER EXPANDED AND THE PROPER IMPLANT DEPTH COULD NOT BE ACHIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1602298 | EVOLUT FX PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVFXPLUS-34 | 00763000716158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | SEE H11... |