EVOLUT PRO TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2025587-2024-02678
- Event Type
- Death
- Date Received
- April 30, 2024
- Date of Event
- April 16, 2024
- Report Date
- July 16, 2024
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IMF 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
UPDATED: B2, 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 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.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE IMPLANT DEPTH AT THE INDEX PROCEDURE WAS -1 MM ON THE NON-CORONARY CUSP (NCC) AND 0 MM ON THE LEFT CORONARY CUSP (LCC). THE VALVE WAS IMPLANTED INTO THE NATIVE ANNULUS. THE PATIENT EXPERIENCED SHORTNESS OF BREATH DUE TO THE GRADIENT INCREASE. THE NON-MEDTRONIC VALVE RESOLVED THE GRADIENT. THE LEFT MAIN OCCLUSION OCCURRED DUE TO THE LITTLE SPACE BETWEEN THE MEDTRONIC VALVE AND THE LEFT MAIN OSTIUM. THE PATIENT DIED A WEEK AND HALF LATER. THE CAUSE OF DEATH IS UNKNOWN.
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT PER THE PHYSICIAN, THE CAUSE OF DEATH WAS CARDIOGENIC SHOCK DUE TO CORONARY OBSTRUCTION. PER THE PHYSICIAN, THE VALVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH DUE TO THE VALVE¿S DEGENERATION.
MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 9 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT RETURNED TO THE HOSPITAL WITH SYMPTOMS. AN ECHOCARDIOGRAM WAS PERFORMED. GRADIENTS OF > 80MMHG WERE REPORTED. THE PATIENT WAS ADMITTED. AFTER THREE DAYS, THE TEAM DECIDED TO PERFORM A TAV IN TAV WITH A NON-MEDTRONIC (EDWARDS SAPIEN 23N MM VALVE). THERE WAS HIGH RISK OF CORONARY OCCLUSION, HOWEVER THERE WAS NOT ENOUGH TIME TO DO A "CHIMNEY" WITH BOTH CORONARY ARTERIES DURING THE PROCEDURE DUE TO THE CONDITION OF THE PATIENT. AFTER THE IMPLANTATION OF THE NON-MEDTRONIC VALVE, A LEFT MAIN CORONARY OCCLUSION OCCURRED. THE PATIENT RECEIVED BYPASS SURGERY AND LEFT THE OPERATION ROOM IN STABLE CONDITION. THE PATIENT REMAINS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). OF NOTE, IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, NO PRE OR POST BALLOON AORTIC VALVULOPLASTY (BAV) WERE PERFORMED. THE OUTCOME OF THE IMPLANT AT THE INDEX PROCEDURE WAS SUCCESSFUL. THE PATIENT HAD HEAVY CALCIFICATION WITHIN THE SINOTUBULAR JUNCTION (STJ) AND ASCENDING AORTA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172245 | EVOLUT PRO TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTPRO-26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H| D| L |