EVOLUT FX VALVE
Report
- Report Number
- 2025587-2024-01867
- Event Type
- Death
- Date Received
- March 25, 2024
- Date of Event
- September 15, 2023
- Report Date
- May 12, 2026
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000822170
- 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: B2. B5. D3. D4. H1. THE ORIGINAL INFORMATION INDICATED THE EVENT WAS A SERIOUS INJURY. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT DIED. THE EVENT IS NOW A REPORTABLE DEATH. H6. 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.
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 FIELDS: B5 B7 ADDED CODES: E0621 A050405. 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 B.5 UPDATED D.4 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.
UPDATED DATA: 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.
MEDTRONIC RECEIVED INFORMATION THAT 1 DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, APHASIA DEVELOPED AND THE PATIENT WAS DIAGNOSED WITH CEREBRAL INFARCTION. CHRONIC PERIOD REHABILITATION WAS NECESSARY AT THE HOSPITAL TO WHICH THE PATIENT WAS TRANSFERRED, HOWEVER, THE PATIENT'S SYMPTOMS EVENTUALLY IMPROVED. MILD PARAVALVULAR LEAK (PVL) WAS ALSO REPORTED. PER THE PHYSICIAN, THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE CEREBRAL INFARCTION AND THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE STROKE WAS ISCHEMIC. PER THE PHYSICIAN, THE STROKE WAS NOT RELATED TO THE VALVE OR DELIVERY CATHETER SYSTEM (DCS), HOWEVER WAS CAUSED BY SPLASHING OF BLOOD CLOTS DUE TO THE PROCEDURE. THROMBOLYSIS WAS PERFORMED. THE PATIENT IS RECOVERING. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO DEVICE MALFUNCTIONS, AND PER THE PHYSICIAN, THERE WAS NO RELATIONSHIP WITH THE VALVE. THE PATIENT WAS REPORTED AS RECOVERING 3 MONTHS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY 1 YEAR AND 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER VALVE, THE PATIENT DIED DUE TO CEREBRAL INFARCTION. PER THE PHYSICIAN, THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE DEATH AND VALVE, OR IMPLANT PROCEDURE.
MEDTRONIC RECEIVED INFORMATION THAT 1 DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, APHASIA DEVELOPED AND THE PATIENT WAS DIAGNOSED WITH CEREBRAL INFARCTION. CHRONIC PERIOD REHABILITATION WAS NECESSARY AT THE HOSPITAL TO WHICH THE PATIENT WAS TRANSFERRED, HOWEVER, THE PATIENT'S SYMPTOMS EVENTUALLY IMPROVED. PER THE PHYSICIAN, THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE CEREBRAL INFARCTION AND THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
MEDTRONIC RECEIVED INFORMATION THAT 1 DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, APHASIA DEVELOPED AND THE PATIENT WAS DIAGNOSED WITH CEREBRAL INFARCTION. CHRONIC PERIOD REHABILITATION WAS NECESSARY AT THE HOSPITAL TO WHICH THE PATIENT WAS TRANSFERRED, HOWEVER, THE PATIENT'S SYMPTOMS EVENTUALLY IMPROVED. MILD PARAVALVULAR LEAK (PVL) WAS ALSO REPORTED. PER THE PHYSICIAN, THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE CEREBRAL INFARCTION AND THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE STROKE WAS ISCHEMIC. PER THE PHYSICIAN, THE STROKE WAS NOT RELATED TO THE VALVE OR DELIVERY CATHETER SYSTEM (DCS), HOWEVER WAS CAUSED BY SPLASHING OF BLOOD CLOTS DUE TO THE PROCEDURE. THROMBOLYSIS WAS PERFORMED. THE PATIENT IS RECOVERING.
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO DEVICE MALFUNCTIONS, AND PER THE PHYSICIAN, THERE WAS NO RELATIONSHIP WITH THE VALVE. THE PATIENT WAS REPORTED AS RECOVERING 3 MONTHS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
MEDTRONIC RECEIVED INFORMATION THAT 1 DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, APHASIA DEVELOPED AND THE PATIENT WAS DIAGNOSED WITH CEREBRAL INFARCTION. CHRONIC PERIOD REHABILITATION WAS NECESSARY AT THE HOSPITAL TO WHICH THE PATIENT WAS TRANSFERRED, HOWEVER, THE PATIENT'S SYMPTOMS EVENTUALLY IMPROVED. MILD PARAVALVULAR LEAK (PVL) WAS ALSO REPORTED. PER THE PHYSICIAN, THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE CEREBRAL INFARCTION AND THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE STROKE WAS ISCHEMIC. PER THE PHYSICIAN, THE STROKE WAS NOT RELATED TO THE VALVE OR DELIVERY CATHETER SYSTEM (DCS), HOWEVER WAS CAUSED BY SPLASHING OF BLOOD CLOTS DUE TO THE PROCEDURE. THROMBOLYSIS WAS PERFORMED. THE PATIENT IS RECOVERING. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO DEVICE MALFUNCTIONS, AND PER THE PHYSICIAN, THERE WAS NO RELATIONSHIP WITH THE VALVE. THE PATIENT WAS REPORTED AS RECOVERING 3 MONTHS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY 1 YEAR AND 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER VALVE, THE PATIENT DIED DUE TO CEREBRAL INFARCTION. PER THE PHYSICIAN, THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE DEATH AND VALVE, OR IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THAT THE CEREBRAL INFARCTION THAT CAUSED THE DEATH NEWLY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 488203 | EVOLUT FX VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVOLUTFX-29 | 00763000822170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| D| H| S |