EVOLUT FX VALVE
Report
- Report Number
- 2025587-2024-05045
- Event Type
- Death
- Date Received
- September 10, 2024
- Date of Event
- September 5, 2024
- Report Date
- November 14, 2024
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IMAGE REVIEW: FIVE MEDIA FILES WERE PROVIDED FOR REVIEW. FLUOROSCOPIC VALVE LOAD INSPECTION WAS PERFORMED AND CONFIRMED A GOOD LOAD. THE VALVE WAS DEPLOYED JUST PRIOR TO THE POINT OF NO RECAPTURE, AND DEPTH ASSESSMENT WAS PERFORMED. DEPTH WAS APPROXIMATELY 0 MM ON THE NON-CORONARY CUSP IN THE CUSP OVERLAP VIEW AND 3-4 MM ON THE LEFT CORONARY CUSP IN THE LEFT ANTERIOR OBLIQUE (LAO) VIEW. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), THE RECOMMENDED TARGET DEPTH IS 3 MM RELATIVE TO THE VALVE ANNULUS. IF THE IMPLANT DEPTH IS =1 MM OR >5 MM, CONSIDER RECAPTURE. IN THIS CASE, A RECAPTURE WAS WARRANTED. THE VALVE WAS RELEASED SLOWLY AND APPEARED TO BE STABLE IMMEDIATELY AFTER RELEASE AND REMAINED STABLE AFTER REMOVAL OF THE DELIVERY CATHETER SYSTEM (DCS). EVIDENCE SUPPORTS THAT THE GUIDEWIRE THAT WAS USED TO DEPLOY THE VALVE INTERACTED WITH THE OUTFLOW OF THE VALVE FRAME CAUSING IT TO DISLODGE AORTIC. AS STATED IN THE IFU, POTENTIAL RISKS ASSOCIATED WITH THE IMPLANTATION OF THE BIOPROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: PROSTHETIC VALVE MIGRATION/EMBOLIZATION; MYOCARDIAL INFARCTION, CARDIAC ARREST, CARDIOGENIC SHOCK, CARDIAC TAMPONADE; EMERGENT SURGICAL OR TRANSCATHETER INTERVENTION (FOR EXAMPLE, CORONARY ARTERY BYPASS, HEART VALVE REPLACEMENT, VALVE EXPLANT, PERCUTANEOUS CORONARY INTERVENTION [PCI], BALLOON VALVULOPLASTY). THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. 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 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.
CONTINUATION OF D10: PRODUCT ID L-EVOLUTFX-2329; PRODUCT SERIAL NUMBER (B)(6); PRODUCT TYPE: COMPRESSION LOADING SYSTEM (CLS) PRODUCT ID D-EVOLUTFX-2329; PRODUCT SERIAL NUMBER (B)(6); PRODUCT TYPE: DELIVERY CATHETER SYSTEM (DCS). 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 DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AFTER VALVE DEPLOYMENT THERE WAS SLIGHT CONTACT FROM THE GUIDEWIRE TO THE UPPER CROWN OF THE VALVE. THIS CAUSED THE VALVE TO DISLODGE INTO THE AORTA AND BEGIN FLOATING FREELY. CORONARY OCCLUSION WAS SUSPECTED AND A SNARING MANEUVER OF THE DEVICE WAS INITIATED. DUE TO WORSENING HEMODYNAMICS, CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED. OPEN SURGERY WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT A PRE-DILATION WAS PERFORMED WITH AN 18X30MM NON-MEDTRONIC (VACS II) BALLOON, AND A NON-MEDTRONIC (SAFARI) GUIDEWIRE WAS USED. THE DEPLOYMENT STARTING POINT WAS BOTTOM OF THE PIG TAIL. PRIOR TO VALVE DISLODGEMENT, THE VALVE WAS AT AN IMPLANT DEPTH OF 3MM ON THE LEFT CORONARY CUSP (LCC) AND 2MM ON THE NON-CORONARY CUSP (NCC). AFTER THE DISLODGEMENT, THE VALVE WAS NO LONGER IN THE AORTIC ANNULUS. THE DISLODGE CAUSED THE VALVE TO OCCLUDE THE CORONARY OSTIA. DURING SURGERY TO IMPLANT A REPLACEMENT VALVE, THE PATIENT PASSED AWAY.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF DEATH WAS AORTIC DISSECTION. THE DEATH WAS NOT CAUSED OR CONTRIBUTED TO BY THE PATIENT'S UNDERLYING MEDICAL HISTORY.
MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AFTER VALVE DEPLOYMENT THERE WAS SLIGHT CONTACT FROM THE GUIDEWIRE TO THE UPPER CROWN OF THE VALVE. THIS CAUSED THE VALVE TO DISLODGE INTO THE AORTA AND BEGIN FLOATING FREELY. CORONARY OCCLUSION WAS SUSPECTED AND A SNARING MANEUVER OF THE DEVICE WAS INITIATED. DUE TO WORSENING HEMODYNAMICS, CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED. OPEN SURGERY WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253276 | EVOLUT FX VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTFX-26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| D| L | SEE H11... |