EVOLUT FX PLUS VALVE
Report
- Report Number
- 2025587-2025-04909
- Event Type
- Death
- Date Received
- July 10, 2025
- Date of Event
- June 26, 2025
- Report Date
- September 18, 2025
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000716141
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME EVOLUT FX PLUS VALVE; PRODUCT ID EVFXPLUS-29 (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025. 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. ADDED SECOND PARAGRAPH. D3. D4. H4. 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.
THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: BRAND NAME: EVOLUTFX DELIVERY CATHETER SYSTEM (DCS), PRODUCT ID: D-EVOLUTFX-2329, LOT: 0012328691, USE BY DATE: 2026-06-24, UDI: (B)(4). UPDATED: B2, B5, D3, D4, D6A, H4, H6, H11. 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 IMPLANT OF THIS EVFXPLUS-29, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED TWICE USING A 20 MM NON-MEDTRONIC BALLOON. THE VALVE AND DELIVERY CATHETER SYSTEM WERE INSERTED INTO THE PATIENT AND ADVANCED TO THE ANNULUS. UPON DEPLOYMENT TO 80%, THE PATIENT'S BLOOD PRESSURE DROPPED. AS A RESULT, LIGHT CARDIOPULMONARY RESUSCITATION (CPR) COMPRESSIONS WERE COMMENCED DURING THE FINAL DEPLOYMENT. SUBSEQUENTLY, A PERICARDIAL EFFUSION WAS IDENTIFIED AND PERICARDIOCENTESIS WAS PERFORMED AS AN INTERVENTION. CARDIOPULMONARY RESUSCITATION CONTINUED WITH "CODE BLUE" PROTOCOL INITIATED. THE PATIENT DIED DESPITE INTERVENTION. PER THE PHYSICIAN, THE PROCEDURE CONTRIBUTED TO THE DEATH. IT IS UNKNOWN WHETHER THE DEVICE CONTRIBUTED TO THE CAUSE OF DEATH.
IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THIS EVFXPLUS-29, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED TWICE USING A 20 MM NON-MEDTRONIC BALLOON. THE VALVE AND DELIVERY CATHETER SYSTEM WERE INSERTED INTO THE PATIENT AND ADVANCED TO THE ANNULUS. UPON DEPLOYMENT TO 80%, THE PATIENT'S BLOOD PRESSURE DROPPED. AS A RESULT, LIGHT CARDIOPULMONARY RESUSCITATION (CPR) COMPRESSIONS WERE COMMENCED DURING THE FINAL DEPLOYMENT. SUBSEQUENTLY, A PERICARDIAL EFFUSION WAS IDENTIFIED AND PERICARDIOCENTESIS WAS PERFORMED AS AN INTERVENTION. CARDIOPULMONARY RESUSCITATION CONTINUED WITH "CODE BLUE" PROTOCOL INITIATED. THE PATIENT DIED DESPITE INTERVENTION. PER THE PHYSICIAN, THE PROCEDURE CONTRIBUTED TO THE DEATH. IT IS UNKNOWN WHETHER THE DEVICE CONTRIBUTED TO THE CAUSE OF DEATH. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF DEATH WAS AN ANNULAR RUPTURE.
IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THIS EVFXPLUS-29, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED TWICE USING A 20 MM NON-MEDTRONIC BALLOON. THE VALVE AND DELIVERY CATHETER SYSTEM WERE INSERTED INTO THE PATIENT AND ADVANCED TO THE ANNULUS. UPON DEPLOYMENT TO 80%, THE PATIENT'S BLOOD PRESSURE DROPPED. AS A RESULT, LIGHT CARDIOPULMONARY RESUSCITATION (CPR) COMPRESSIONS WERE COMMENCED DURING THE FINAL DEPLOYMENT. SUBSEQUENTLY, A PERICARDIAL EFFUSION WAS IDENTIFIED AND PERICARDIOCENTESIS WAS PERFORMED AS AN INTERVENTION. CARDIOPULMONARY RESUSCITATION CONTINUED WITH "CODE BLUE" PROTOCOL INITIATED. THE PATIENT DIED DESPITE INTERVENTION. PER THE PHYSICIAN, THE PROCEDURE CONTRIBUTED TO THE DEATH. IT IS UNKNOWN WHETHER THE DEVICE CONTRIBUTED TO THE CAUSE OF DEATH. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF DEATH WAS AN ANNULAR RUPTURE. ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE VALVE CAUSED THE ANNULAR RUPTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774248 | EVOLUT FX PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVFXPLUS-29 | 0012328691 | 00763000716141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Death| R | SEE H11. |