EVOLUT FX VALVE
Report
- Report Number
- 2025587-2024-07385
- Event Type
- Death
- Date Received
- December 17, 2024
- Date of Event
- December 11, 2024
- Report Date
- March 7, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IMAGE REVIEW: FIVE MEDIA FILES AND ONE STATIC IMAGE WERE PROVIDED FOR REVIEW. PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. FLUOROSCOPY VALVE LOAD INSPECTION WAS NOT PROVIDED FOR REVIEW THUS IT IS NOT POSSIBLE TO VALIDATE A GOOD LOAD. A PRE BALLOON AORTIC VALVULOPLASTY WAS PERFORMED PRIOR TO THE VALVE IMPLANT. THE VALVE WAS DEPLOYED JUST PRIOR TO THE POINT OF NO RECAPTURE AND DEPTH ASSESSMENT WAS PERFORMED BUT CONTRAST INJECTED WAS NOT SUFFICIENT TO PROPERLY VISUALIZE DEPTH OF THE VALVE. HOWEVER, IT WAS REPORTED THAT IMPLANT DEPTH WAS 2MM ON THE RIGHT CORONARY CUSP AND 1 MM ON THE LEFT CORONARY CUSP. OF NOTE, THE RECOMMENDED TARGET DEPTH IS 3 MM RELATIVE TO THE VALVE ANNULUS. IF THE IMPLANT DEPTH IS =1 MM OR >5 MM, CONSIDER RECAPTURE. A POST IMPLANT DILATATION WAS PERFORMED. IT WAS REPORTED THAT DURING WITHDRAWAL OF THE BALLOON, THE VALVE DISLODGED. IMAGES OF THE DISLODGEMENT WERE NOT PROVIDED FOR REVIEW THUS IT IS NOT POSSIBLE TO VALIDATE CAUSE OF DISLODGMENT. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED UPDATED H.6. 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.
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.
D10: MEDTRONIC PRODUCT ID: D-EVOLUTFX-2329 (LOT: 0012421126); PRODUCT TYPE: 0195-HEART VALVES; NON-IMPLANTABLE (SECOND DCS LOT NUMBER PREVIOUSLY UNKNOWN) UPDATED DATA: B3, B5, D6A, D10 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.
CONTINUATION OF D10: MEDTRONIC PRODUCT ID: D-EVOLUTFX-2329 (LOT: 0012421126); PRODUCT TYPE: 0195-HEART VALVES; NON-IMPLANTABLE MEDTRONIC PRODUCT ID: D-EVOLUTFX-2329 (LOT: UNKNOWN); PRODUCT TYPE: 0195-HEART VALVES; NON-IMPLANTABLE MEDTRONIC PRODUCT ID: EVOLUTFX-26 (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2024; EXPLANT DATE: NOT EXPLANTED, NON-MEDTRONIC PRODUCT ID: BD 20MM TRUE DILATATION BALLOON, LOT #: UNKNOWN, UBD: UNKNOWN NON-MEDTRONIC PRODUCT ID: 18FR GORE MEDICAL DRYSEAL INTRODUCER SHEATH, LOT #: UNKNOWN, UBD: UNKNOWN NON-MEDTRONIC PRODUCT ID: BOSTON SCIENTIFIC SAFARI GUIDEWIRE, LOT #: UNKNOWN, UBD: UNKNOWN, UNKNOWN SNARE. 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. 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 DURING A TRANSCATHETER HEART VALVE REPLACEMENT PROCEDURE INVOLVING THIS EVOLUT FX 26 VALVE, A PRE-IMPLANT DILATION WAS PERFORMED USING A 20MM NON-MEDTRONIC (TRUE) BALLOON THROUGH AN 18FR NON-MEDTRONIC (GORE DRYSEAL) SHEATH. FOLLOWING THE PRE-IMPLANT DILATION, A 14FR DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT THROUGH THE 18FR NON-MEDTRONIC SHEATH OVER A NON-MEDTRONIC (SAFARI) GUIDEWIRE VIA THE RIGHT FEMORAL ARTERY AND NAVIGATED TO THE HEART. THE VALVE WAS FULLY DEPLOYED ON THE FIRST DEPLOYMENT ATTEMPT AT AN IMPLANT DEPTH OF 2MM ON THE NON-CORONARY CUSP (NCC) AND 1MM ON THE LEFT CORONARY CUSP (LCC) WITH COMMISSURAL ALIGNMENT. REVIEW OF IMAGING FROM THE RIGHT ANTERIOR OBLIQUE VIEW REVEALED A CONSTRAINED APPEARANCE IN THE FRAME OF THE BIOPROSTHETIC VALVE. A POST-IMPLANT DILATION WAS PERFORMED USING THE SAME 20MM NON-MEDTRONIC (TRUE) BALLOON AND 18FR NON-MEDTRONIC (GORE DRYSEAL) SHEATH USED FOR THE PRE-IMPLANT DILATION. THE DILATION OF THE VALVE FRAME WAS SUCCESSFUL; HOWEVER, WHEN THE NON-MEDTRONIC (TRUE) BALLOON WAS WITHDRAWN, THE BIOPROSTHETIC VALVE DISLODGED TOWARDS THE ASCENDING AORTA. THE VALVE WAS SNARED, BUT THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND CARDIOPULMONARY RESUSCITATION WAS INITIATED. THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION; DEFIBRILLATION WAS PERFORMED AND THE PATIENT RETURNED TO SINUS RHYTHM. A NEW EVOLUT FX 26 VALVE WAS LOADED ONTO A NEW DCS AND FULLY DEPLOYED SUCCESSFULLY AT AN IMPLANT DEPTH OF 3MM ON THE NCC AND 8MM ON THE LCC. THERE WAS NO PARAVALVULAR LEAK, AORTIC INSUFFICIENCY, CONCERNING GRADIENT, OR VASCULAR ISSUES. HOWEVER, THE PATIENT DIED AFTER THE PROCEDURE. THE CAUSE OF DEATH WAS NOT REPORTED. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION INDICATED THAT A ¿HEAVILY¿ CALCIFIED AORTIC VALVE CONTRIBUTED TO THE DISLODGEMENT OF THE FIRST VALVE. DEPLOYMENT OF THE FIRST VALVE STARTED AT THE BOTTOM OF THE PIGTAIL CATHETER. WITH THE DISLODGEMENT OF THE FIRST VALVE, THE VALVE DEPTH WAS 3 MILLIMETERS (MM) ON THE NON-CORONARY CUSP (NCC) AND 8MM ON THE LEFT CORONARY CUSP (LCC). ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE CAUSE OF DEATH WAS RHYTHM CHANGE. THE PATIENT ENTERED ATRIO-VENTRICULAR (AV) BLOCK AND DIED IN THE CCU. NO AUTOPSY WAS PERFORMED.
ADDITIONAL INFORMATION INDICATED THAT A ¿HEAVILY¿ CALCIFIED AORTIC VALVE CONTRIBUTED TO THE DISLODGEMENT OF THE FIRST VALVE. DEPLOYMENT OF THE FIRST VALVE STARTED AT THE BOTTOM OF THE PIGTAIL CATHETER. WITH THE DISLODGEMENT OF THE FIRST VALVE, THE VALVE DEPTH WAS 3 MILLIMETERS (MM) ON THE NON-CORONARY CUSP (NCC) AND 8 MM ON THE LEFT CORONARY CUSP (LCC).
IIT WAS REPORTED DURING A TRANSCATHETER HEART VALVE REPLACEMENT PROCEDURE INVOLVING THIS EVOLUT FX 26 VALVE, A PRE-IMPLANT DILATION WAS PERFORMED USING A 20MM NON-MEDTRONIC (TRUE) BALLOON THROUGH AN 18FR NON-MEDTRONIC (GORE DRYSEAL) SHEATH. FOLLOWING THE PRE-IMPLANT DILATION, A 14FR DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT THROUGH THE 18FR NON-MEDTRONIC SHEATH OVER A NON-MEDTRONIC (SAFARI) GUIDEWIRE VIA THE RIGHT FEMORAL ARTERY AND NAVIGATED TO THE HEART. THE VALVE WAS FULLY DEPLOYED ON THE FIRST DEPLOYMENT ATTEMPT AT AN IMPLANT DEPTH OF 2MM ON THE NON-CORONARY CUSP (NCC) AND 1MM ON THE LEFT CORONARY CUSP (LCC) WITH COMMISSURAL ALIGNMENT. REVIEW OF IMAGING FROM THE RIGHT ANTERIOR OBLIQUE VIEW REVEALED A CONSTRAINED APPEARANCE IN THE FRAME OF THE BIOPROSTHETIC VALVE. A POST-IMPLANT DILATION WAS PERFORMED USING THE SAME 20MM NON-MEDTRONIC (TRUE) BALLOON AND 18FR NON-MEDTRONIC (GORE DRYSEAL) SHEATH USED FOR THE PRE-IMPLANT DILATION. THE DILATION OF THE VALVE FRAME WAS SUCCESSFUL; HOWEVER, WHEN THE NON-MEDTRONIC (TRUE) BALLOON WAS WITHDRAWN, THE BIOPROSTHETIC VALVE DISLODGED TOWARDS THE ASCENDING AORTA. THE VALVE WAS SNARED, BUT THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND CARDIOPULMONARY RESUSCITATION WAS INITIATED. THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION; DEFIBRILLATION WAS PERFORMED AND THE PATIENT RETURNED TO SINUS RHYTHM. A NEW EVOLUT FX 26 VALVE WAS LOADED ONTO A NEW DCS AND FULLY DEPLOYED SUCCESSFULLY AT AN IMPLANT DEPTH OF 3MM ON THE NCC AND 8MM ON THE LCC. THERE WAS NO PARAVALVULAR LEAK, AORTIC INSUFFICIENCY, CONCERNING GRADIENT, OR VASCULAR ISSUES. HOWEVER, THE PATIENT DIED AFTER THE PROCEDURE. THE CAUSE OF DEATH WAS NOT REPORTED. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1437383 | EVOLUT FX VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTFX-26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening| D| R | "SEE H11...."| SEE H11. |