EVOLUT FX DCS
Report
- Report Number
- 9612164-2025-05862
- Event Type
- Malfunction
- Date Received
- November 26, 2025
- Date of Event
- November 24, 2025
- Report Date
- December 10, 2025
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NPT
- UDI-DI
- 00763000589707
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID EVOLUTFX-26 (R090210); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; 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, D4, H4. 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.
CORRECTED H.6 FDM CODE 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 HEART VALVE PROCEDURE INTO A PATIENT WITH A PREVIOUS NON-MEDTRONIC SURGICAL VALVE WHICH WAS PRE-DILATED WITH A 22MM SEMI-COMPLIANT BALLOON., T WAS DIFFICULTY CROSSING THE VALVE WITH THE GUIDEWIRE. AN ATTEMPT TO GO TRANSEPTAL WAS MADE, DURING WHICH THE PATIENT'S PRESSURE DROPPED AND THE WIRE HAD TO BE REMOVED. AFTER THE PATIENT STABILIZED, THE WIRE WAS SUCCESSFULLY PASSED THROUGH THE VALVE. THE VALVE WAS DEPLOYED TWICE AND EACH TIME IT DISLODGED UP. ON THE THIRD DEPLOYMENT, THE VALVE REMAINED IN PLACE AT A DEPTH OF 4MM ON THE LEFT CORONARY CUSP (LCC) IN THE 3-CUSP VIEW, WITH A UNIFORM DEPTH OF 4MM ALL AROUND. POST-DILATATION WAS PERFORMED WITH A 22MM SEMI-COMPLIANT BALLOON TO ENSURE THE VALVE WAS WELL EXPANDED, WITH NO MOVEMENT OBSERVED IN THE BALLOON OR VALVE, A SINGLE-DIGIT GRADIENT, AND NO LEAK DETECTED. AFTER CLOSURE OF THE FEMORAL ACCESSES, A DROP IN PRESSURE TO 70MMHG WAS OBSERVED, AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DIAGNOSED AN EMBOLIZED VALVE. THE PATIENT REQUIRED INTUBATION. A NON-MEDTRONIC VALVE WAS IMPLANTED AS A REPLACEMENT, AND THE MEDTRONIC TRANSCATHETER VALVE WAS LEFT IN THE ASCENDING AORTA DUE TO THE RISK OF AORTIC DISSECTION IF IT WERE TO BE SNARED INTO THE DESCENDING AORTA. THE INTUBATED PATIENT LEFT THE ROOM WITH STABLE PRESSURE.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE INTO A PATIENT WITH A PREVIOUS NON-MEDTRONIC SURGICAL VALVE WHICH WAS PRE-DILATED WITH A 22MM SEMI-COMPLIANT BALLOON, THERE WAS DIFFICULTY CROSSING THE VALVE WITH THE GUIDEWIRE. AN ATTEMPT TO GO TRANSEPTAL WAS MADE, DURING WHICH THE PATIENT'S PRESSURE DROPPED AND THE WIRE HAD TO BE REMOVED. AFTER THE PATIENT STABILIZED, THE WIRE WAS SUCCESSFULLY PASSED THROUGH THE VALVE. THE VALVE WAS DEPLOYED TWICE AND EACH TIME IT DISLODGED UP. ON THE THIRD DEPLOYMENT, THE VALVE REMAINED IN PLACE AT A DEPTH OF 4MM ON THE LEFT CORONARY CUSP (LCC) IN THE 3-CUSP VIEW, WITH A UNIFORM DEPTH OF 4MM ALL AROUND. POST-DILATATION WAS PERFORMED WITH A 22MM SEMI-COMPLIANT BALLOON TO ENSURE THE VALVE WAS WELL EXPANDED, WITH NO MOVEMENT OBSERVED IN THE BALLOON OR VALVE, A SINGLE-DIGIT GRADIENT, AND NO LEAK DETECTED. AFTER CLOSURE OF THE FEMORAL ACCESSES, A DROP IN PRESSURE TO 70MMHG WAS OBSERVED, AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DIAGNOSED AN EMBOLIZED VALVE. THE PATIENT REQUIRED INTUBATION. A NON-MEDTRONIC VALVE WAS IMPLANTED AS A REPLACEMENT, AND THE MEDTRONIC TRANSCATHETER VALVE WAS LEFT IN THE ASCENDING AORTA DUE TO THE RISK OF AORTIC DISSECTION IF IT WERE TO BE SNARED INTO THE DESCENDING AORTA. THE INTUBATED PATIENT LEFT THE ROOM WITH STABLE PRESSURE. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC (LUNDERQUIST) GUIDEWIRE WAS USED DURING DEPLOYMENT FOR STABILITY. THERE WAS NO VISUAL UNDER-EXPANSION PRIOR TO THE POST-IMPLANT BALLOON DILATION, HOWEVER, THE DOCTORS WANTED TO MAKE SURE THAT THE VALVE WOULD OPEN AS MUCH AS POSSIBLE. AS OF TWO DAYS POST-IMPLANT, THE PATIENT WAS UNABLE TO MOVE THEIR ARM.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE INTO A PATIENT WITH A PREVIOUS NON-MEDTRONIC SURGICAL VALVE WHICH WAS PRE-DILATED WITH A 22MM SEMI-COMPLIANT BALLOON, THERE WAS DIFFICULTY CROSSING THE VALVE WITH THE GUIDEWIRE. AN ATTEMPT TO GO TRANSEPTAL WAS MADE, DURING WHICH THE PATIENT'S PRESSURE DROPPED AND THE WIRE HAD TO BE REMOVED. AFTER THE PATIENT STABILIZED, THE WIRE WAS SUCCESSFULLY PASSED THROUGH THE VALVE. THE VALVE WAS DEPLOYED TWICE AND EACH TIME IT DISLODGED UP. ON THE THIRD DEPLOYMENT, THE VALVE REMAINED IN PLACE AT A DEPTH OF 4MM ON THE LEFT CORONARY CUSP (LCC) IN THE 3-CUSP VIEW, WITH A UNIFORM DEPTH OF 4MM ALL AROUND. POST-DILATATION WAS PERFORMED WITH A 22MM SEMI-COMPLIANT BALLOON TO ENSURE THE VALVE WAS WELL EXPANDED, WITH NO MOVEMENT OBSERVED IN THE BALLOON OR VALVE, A SINGLE-DIGIT GRADIENT, AND NO LEAK DETECTED. AFTER CLOSURE OF THE FEMORAL ACCESSES, A DROP IN PRESSURE TO 70MMHG WAS OBSERVED, AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DIAGNOSED AN EMBOLIZED VALVE. THE PATIENT REQUIRED INTUBATION. A NON-MEDTRONIC VALVE WAS IMPLANTED AS A REPLACEMENT, AND THE MEDTRONIC TRANSCATHETER VALVE WAS LEFT IN THE ASCENDING AORTA DUE TO THE RISK OF AORTIC DISSECTION IF IT WERE TO BE SNARED INTO THE DESCENDING AORTA. THE INTUBATED PATIENT LEFT THE ROOM WITH STABLE PRESSURE. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC (LUNDERQUIST) GUIDEWIRE WAS USED DURING DEPLOYMENT FOR STABILITY. THERE WAS NO VISUAL UNDER-EXPANSION PRIOR TO THE POST-IMPLANT BALLOON DILATION, HOWEVER, THE DOCTORS WANTED TO MAKE SURE THAT THE VALVE WOULD OPEN AS MUCH AS POSSIBLE. AS OF TWO DAYS POST-IMPLANT, THE PATIENT WAS UNABLE TO MOVE THEIR ARM. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN ATTRIBUTED THE LACK OF ARM MOVEMENT TO A PROBABLE STROKE DUE TO CALCIUM IN THE NATIVE VALVE BUT THIS WAS UNCONFIRMED. IT WAS REPORTED THAT THE VALVE DID NOT MOVE DURING THE POST-DILATATION INDICATING THAT THE VALVE WAS WELL ANCHORED AND DID NOT SEEM UNSTABLE. SINCE THE VALVE STAYED ANCHORED DURING THE POST-DILATATION, IT WAS UNCERTAIN AS TO WHY IT DID NOT MOVE WITH THE BALLOON INSIDE BUT DID TEN MINUTES AFTER. AT THAT POINT, THE DELIVERY CATHETER SYSTEM (DCS) WAS NO LONGER IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2136979 | EVOLUT FX DCS | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC IRELAND | D-EVOLUTFX-2329 | 0012986114 | 00763000589707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |