EVOLUT FX PLUS VALVE
Report
- Report Number
- 2025587-2024-05206
- Event Type
- Injury
- Date Received
- September 17, 2024
- Date of Event
- September 13, 2024
- Report Date
- October 16, 2024
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- UDI-DI
- 00763000716141
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME EVOLUT FX DCS; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012275351); PRODUCT TYPE: 0195-HEART VALVES BRAND NAME EVOLUT FX DCS; PRODUCT ID D-EVOLUTFX-34 (LOT: 0012245462); PRODUCT TYPE: 0195-HEART VALVES BRAND NAME L-EVOLUTFX-2329; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012280006); PRODUCT TYPE: 0195-HEART VALVES BRAND NAME L-EVOLUTFX-34; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012210396); PRODUCT TYPE: 0195-HEART VALVES BRAND NAME EVOLUTFX-34; PRODUCT ID HEART VALVE (SERIAL: (B)(6); PRODUCT TYPE: 0195-HEART VALVES UPDATED DATA: A4, B1, B5, B7, D10, H1, H6 A DUPLICATE REGULATORY REPORT WAS IDENTIFIED, REPORT # 2025587-2024-05312. GOING FORWARD ANY NEW REPORTABLE INFORMATION PERTAINING TO THIS EVENT WILL BE SUBMITTED VIA THIS CURRENT REGULATORY REPORT, #. 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 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.
SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME EVOLUT FX DCS; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012275351); 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.
ADDITIONAL INFORMATION WAS RECEIVED THAT AT 80% DEPLOYMENT, THE VALVE DISLODGED TOWARD THE LEFT VENTRICLE AND HAD DIFFICULTY ANCHORING IN PLACE. THE VALVE WAS SUBSEQUENTLY RECAPTURED AND WITH DRAWN FROM THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION INDICATED THAT DURING THE ATTEMPTED IMPLANT OF THE 29MM VALVE, HYPOTENSION OCCURRED DURING THE FULL RECAPTURE OF THIS VALVE AND VASOPRESSOR SUPPORT WAS REQUIRED. FOLLOWING THE FULL RECAPTURE OF THE 29MM VALVE AND THE WITHDRAWAL OF THE DELIVERY CATHETER SYSTEM (DCS), A 34 MM VALVE WAS SUCCESSFULLY DEPLOYED, AND THE HYPOTENSION RESOLVED. PER THE PHYSICIAN, THE HYPOTENSION WAS PROCEDURE RELATED BUT UNRELATED TO THE DELIVERY CATHETER SYSTEM (DCS) AND VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE DEPLOYMENT STARTING POINT WAS THE BOTTOM OF THE PIGTAIL CATHETER. THE VALVE DISLODGED VENTRICULAR, HOWEVER PRIOR TO THE DISLODGEMENT, THE VALVE WAS POSITIONED AT 3 MM ON THE NON-CORONARY CUSP (NCC) AND 5 MM ON THE LEFT CORONARY CUSP (LCC). THE SAFARI EXTRA SMALL CURVE GUIDEWIRE WAS UTILIZED DURING THIS PROCEDURE.
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DEVICE WAS INSPECTED PRIOR TO USE AND NO PRE-DILATION WAS PERFORMED. THE PATIENT'S ANNULAR DIMENSIONS WERE BORDERLINE BETWEEN A 29MM AND 34MM VALVE. THE TEAM ATTEMPTED IMPLANT WITH A 29MM VALVE, HOWEVER THE VALVE WAS UNDERSIZED AND WAS THEREFORE REMOVED. A LARGER VALVE WAS SUCCESSFULLY USED FOR IMPLANT. PER THE PHYSICIAN, THE PATIENT'S ANATOMY CONTRIBUTED TO THE EVENT. NO PROCEDURAL DELAY OCCURRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1901736 | EVOLUT FX PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVFXPLUS-29 | 00763000716141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Male | Required Intervention | "SEE H11....".| SEE H11... |