EVOLUT FX PLUS VALVE
Report
- Report Number
- 2025587-2025-03433
- Event Type
- Malfunction
- Date Received
- May 6, 2025
- Date of Event
- April 29, 2025
- Report Date
- August 4, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- UDI-DI
- 00763000920449
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-34 (LOT: 0012637274); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: NON-IMPLANTABLE DEVICE PRODUCT ID D-EVOLUTFX-34 (LOT: 0012637274); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: NON-IMPLANTABLE DEVICE PRODUCT ID L-EVOLUTFX-34 (LOT: 0012432656); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: NON-IMPLANTABLE DEVICE PRODUCT ID EVFXPLUS-34 (K063647); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. H6. THE CODES PRESENT IN SECTION H6 CORRESPOND TO MULTIPLE COMPONENTS/PRODUCTS THAT COMPRISE THIS REPORTED EVENT. 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: D4 D9 H2 H3 H6 PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE VALVE WAS RETURNED TO THE GALWAY PRODUCT ANALYSIS LAB LOADED INSIDE THE DELIVERY SYSTEM. THE VALVE WAS REMOVED FROM THE DELIVERY SYSTEM AND FORWARDED TO THE SANTA ANA PRODUCT ANALYSIS LAB. THE VALVE WAS RECEIVED FULLY SUBMERGED IN CLOUDY 0.2% GLUTARALDEHYDE IN A RETURN KIT JAR. THE VALVE WAS DISCOLORED SHOWING EVIDENCE OF BLOOD CONTACT. THE VALVE WAS RETURNED IN A HEAVILY COMPRESSED STATE WITH THE OUTFLOW FRAME DISPLAYING AN ELLIPTICAL APPEARANCE AND INFLOW DISPLAYING A RENIFORM APPEARANCE. AS RECEIVED, ALL LEAFLETS APPEARED PARTIALLY CLOSED WITH A GAP BETWEEN THE FREE MARGINS. ALL LEAFLETS WERE PLIABLE AND EXHIBITED SIGNS OF SEVERE CREASES AND FRAME IMPRINTS. ALL COMMISSURES APPEARED INTACT. THE VALVE WAS SUBMERGED IN A WARM (APPROXIMATELY 37 CELSIUS) SALINE BATH; THE FRAME EXPANDED WITH THE OBSERVED CRIMPED STATE AND OUTFLOW/INFLOW ELLIPTICAL AND RENIFORM APPEARANCES RESOLVING. THE VALVE APPEARED TO RETAIN A COMPRESSED STATE POSSIBLY FROM BEING INSIDE THE CAPSULE OF THE DELIVERY SYSTEM FOR AN UNKNOWN DURATION OF TIME. THE TISSUE ALONG THE OUTER WRAP APPEARED DRY. THERE WERE NO BENDS OR KINKS TO THE FRAME. SCRATCHES WERE OBSERVED ON THE MARGIN OF ATTACHMENT OF ALL LEAFLETS. THE FRAME SIZE DIAMETER WAS VERIFIED USING A PRODUCTION INSPECTION FIXTURE FOR SIZE 34 MM. THE VALVE¿S INFLOW CROWN WAS INSERTED INTO THE FIXTURE. THE VALVE¿S INFLOW CROWN APPEARED TO TOUCH THE INNER BLACK LIMITS OF THE FIXTURE. THIS OBSERVATION WAS ESCALATED TO POST MARKET ENGINEERING FOR ADDITIONAL INVESTIGATION. DUE TO THE RECEIVED CONDITION OF THE VALVE, A DEPLOYMENT SIMULATION COULD NOT BE PERFORMED TO ADDRESS THE REPORTED INFOLDING ALLEGATION. 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: B5. ADDITIONAL CODES. 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 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. 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 THAT DURING THE PROCEDURE INVOLVING A TRANSCATHETER AORTIC VALVE IMPLANTATION USING THE EVOLUT FX+34 VALVE, A PRE-IMPLANT BALLOON DILATION WAS PERFORMED WITH A 22MM BALLOON. THE FIRST ATTEMPT TO IMPLANT THE VALVE REQUIRED REPOSITIONING, AND THE FIRST RECAPTURE ATTEMPT RESULTED IN INFOLDING OF THE VALVE FRAME. THE VALVE WAS WITHDRAWN AND REPLACED WITH ANOTHER EVOLUT FX+34 VALVE. HOWEVER, DURING THE RECAPTURE ATTEMPT WITH THE SECOND VALVE FOR REPOSITIONING, INFOLDING OCCURRED AGAIN. ANOTHER PRE-IMPLANT BALLOON DILATION USING THE SAME 22MM BALLOON WAS PERFORMED. SUBSEQUENTLY, AN EVOLUT FX+29 VALVE WAS USED, WHICH WAS IMPLANTED SUCCESSFULLY. THE BORDERLINE SIZING OF THE AORTIC VALVE AND THE PATIENT'S ANATOMY CONTRIBUTED TO THE INFOLDING OF THE TWO EVOLUT FX+34 VALVES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1885603 | EVOLUT FX PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVFXPLUS-34 | 00763000920449 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | SEE H11... |