EVOLUT FX PLUS VALVE
Report
- Report Number
- 2025587-2024-06628
- Event Type
- Injury
- Date Received
- November 19, 2024
- Date of Event
- November 11, 2024
- Report Date
- February 17, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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: H6. 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: SECTION B5 - ADDED FOURTH PARAGRAPH. CORRECTED INFORMATION: SECTION H6 - IME/ANNEX E 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. 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.
B3: EVENT DATE IS NOT KNOWN. B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. E1: INITIAL REPORTER AND FACILITY DETAILS WERE NOT PROVIDED CONTINUATION OF D10: PRODUCT ID: L-EVOLUTFX-2329, (LOT: 0012307634); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID: D-EVOLUTFX-2329, (LOT: 0012358650); PRODUCT TYPE: 0195-HEART VALVES. 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 WITHIN A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL VALVE (TRIFECTA GT), A POST-IMPLANT BALLOON DILATATION WAS PERFORMED. WHEN PULLING THE BALLOON OUT OF THE VALVE, THE BALLOON TOUCHED THE VALVE'S UPPER CROWN FROM THE INNER CURVE AND CAUSED THE VALVE TO DISLODGE. NO TREATMENT WAS REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT A PRE-IMPLANT BALLOON DILATATION WAS PERFORMED. UNDER RAPID PACING, A POST-IMPLANT DILATATION WAS PERFORMED DUE TO THE PRESENCE OF CALCIFICATION AND UNDEREXPANSION OF THE BIOPROSTHETIC VALVE WHICH RESULTED IN PARAVALVULAR LEAK. THE DISLODGED VALVE WAS SNARED TO THE DESCENDING AORTA AND A NON-MEDTRONIC VALVE WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT AS THE VALVE DISLODGED UPWARD IT WAS NOT ABLE TO COME IN CONTACT WITH THE ANNULUS AND WAS FREELY IN THE ASCENDING AORTA BEFORE IT WAS SNARED TO THE DESCENDING AORTA.
MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL VALVE (TRIFECTA GT), A POST-IMPLANT BALLOON DILATATION WAS PERFORMED. WHEN PULLING THE BALLOON OUT OF THE VALVE, THE BALLOON TOUCHED THE VALVE'S UPPER CROWN FROM THE INNER CURVE AND CAUSED THE VALVE TO DISLODGE. NO TREATMENT WAS REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT A PRE-IMPLANT BALLOON DILATATION WAS PERFORMED. UNDER RAPID PACING, A POST-IMPLANT DILATATION WAS PERFORMED DUE TO THE PRESENCE OF CALCIFICATION AND UNDEREXPANSION OF THE BIOPROSTHETIC VALVE WHICH RESULTED IN PARAVALVULAR LEAK. THE DISLODGED VALVE WAS SNARED TO THE DESCENDING AORTA AND A NON-MEDTRONIC VALVE WAS IMPLANTED.
MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL VALVE (TRIFECTA GT), A POST-IMPLANT BALLOON DILATATION WAS PERFORMED. WHEN PULLING THE BALLOON OUT OF THE VALVE, THE BALLOON TOUCHED THE VALVE'S UPPER CROWN FROM THE INNER CURVE AND CAUSED THE VALVE TO DISLODGE. NO TREATMENT WAS REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT A PRE-IMPLANT BALLOON DILATATION WAS PERFORMED. UNDER RAPID PACING, A POST-IMPLANT DILATATION WAS PERFORMED DUE TO THE PRESENCE OF CALCIFICATION AND UNDEREXPANSION OF THE BIOPROSTHETIC VALVE WHICH RESULTED IN PARAVALVULAR LEAK. THE DISLODGED VALVE WAS SNARED TO THE DESCENDING AORTA AND A NON-MEDTRONIC VALVE WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT AS THE VALVE DISLODGED UPWARD IT WAS NOT ABLE TO COME IN CONTACT WITH THE ANNULUS AND WAS FREELY IN THE ASCENDING AORTA BEFORE IT WAS SNARED TO THE DESCENDING AORTA. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE UNDER-EXPANSION OF THE VALVE RESULTED IN SEVERE PARAVALVULAR LEAK.
MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL VALVE, A POST-IMPLANT BALLOON DILATATION WAS PERFORMED. WHEN PULLING THE BALLOON OUT OF THE VALVE, THE BALLOON TOUCHED THE VALVE'S UPPER CROWN FROM THE INNER CURVE AND CAUSED THE VALVE TO DISLODGE. NO TREATMENT WAS REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1323786 | EVOLUT FX PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVFXPLUS-26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | SEE H11... |