EVOLUT FX VALVE
Report
- Report Number
- 2025587-2024-06124
- Event Type
- Death
- Date Received
- October 29, 2024
- Date of Event
- August 23, 2024
- Report Date
- February 17, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED DATA: B5. A FOURTH PARAGRAPH WAS ADDED. 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.
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.
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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
UPDATED DATA: 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.
MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS HOSPITALIZED. DURING HOSPITALIZATION, THE PATIENT PASSED AWAY DUE TO HEART FAILURE. PER THE PHYSICIAN, IT IS UNKNOWN WHETHER THE DEVICE OR THE PROCEDURE CONTRIBUTED TO THE CAUSE OF DEATH. ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE DEVICE CANNOT BE EXCLUDED AS A CONTRIBUTING CAUSE TO THE DEATH. ADDITIONALLY, THE PATIENT'S UNDERLYING MEDICAL CONDITION INCLUDING A THORACIC STENT GRAFT, THROMBOCYTOPENIA, AND A HISTORY OF AN AORTIC VALVE REPLACEMENT ALSO COULD HAVE CAUSED OR CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION WAS RECEIVED THAT IMMEDIATELY FOLLOWING IMPLANT OF THE VALVE, THE VALVE WAS FUNCTIONING NORMALLY. UPON REVIEW OF ECHOCARDIOGRAM, PARAVALVULAR LEAK (PVL) AND MITRAL REGURGITATION WERE OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT THE SEVERITY OF BOTH THE PVL AND MITRAL REGURGITATION WAS MODERATE. PER THE PHYSICIAN, THE RELATEDNESS BETWEEN THE MEDTRONIC VALVE AND MITRAL REGURGITATION WAS LOW.
MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS HOSPITALIZED. DURING HOSPITALIZATION, THE PATIENT PASSED AWAY DUE TO HEART FAILURE. PER THE PHYSICIAN, IT IS UNKNOWN WHETHER THE DEVICE OR THE PROCEDURE CONTRIBUTED TO THE CAUSE OF DEATH.
ADDITIONAL INFORMATION WAS RECEIVED THAT IMMEDIATELY FOLLOWING IMPLANT OF THE VALVE, THE VALVE WAS FUNCTIONING NORMALLY. UPON REVIEW OF ECHOCARDIOGRAM, PARAVALVULAR LEAK (PVL) AND MITRAL REGURGITATION WERE OBSERVED.
MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS HOSPITALIZED. DURING HOSPITALIZATION, THE PATIENT PASSED AWAY DUE TO HEART FAILURE. PER THE PHYSICIAN, IT IS UNKNOWN WHETHER THE DEVICE OR THE PROCEDURE CONTRIBUTED TO THE CAUSE OF DEATH. ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE DEVICE CANNOT BE EXCLUDED AS A CONTRIBUTING CAUSE TO THE DEATH. ADDITIONALLY, THE PATIENT'S UNDERLYING MEDICAL CONDITION INCLUDING A THORACIC STENT GRAFT, THROMBOCYTOPENIA, AND A HISTORY OF AN AORTIC VALVE REPLACEMENT ALSO COULD HAVE CAUSED OR CONTRIBUTED TO THE DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320445 | EVOLUT FX VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTFX-26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |