EVOLUT FX DCS
Report
- Report Number
- 9612164-2025-04956
- Event Type
- Injury
- Date Received
- October 7, 2025
- Date of Event
- September 10, 2025
- Report Date
- April 29, 2026
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: BRAND NAME [TAV EVFXPLUS-26 PRODUCT ID [EVFXPLUS-26] (SERIAL: [SERIAL # (B)(6); BRAND NAME [GUIDEWIRE GWBC30 CONFIDA 26L PRODUCT ID [GWBC30] (SERIAL: [LOT #UNKNOWN]). SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: BRAND NAME DELIV SYS D-EVOLUTFX; PRODUCT ID D-EVOLUTFX-2329 (0012896872); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE N/A ; EXPLAN T DATE N/A BRAND NAME EVOLUT FX PLUS VALVE; PRODUCT ID EVFXPLUS-29 (SERIAL: (B)(6); PRODUCT TYPE: 0195-HEART VALVES; BRAND NAME: UNKNOWN VASCULAR BALLOON; PRODUCT ID: UNKNOWN (LOT: UNKNOWN); PRODUCT TYPE: VASCULAR BALLOON, IMPLANT DATE N/A; EXPLANT DATE N/A H6: B17 (GUIDEWIRE), B18 (DCS), B21 (VALVE) D9 FOR SYSTEM REPORTED VALVE (K949910): DEVICE AVAILABLE FOR EVALUATION: YES RETURN DATE: 2025-SEP-24 PRODUCT ANALYSIS (VALVE K949910): THE PRODUCT HAS BEEN RETURNED FOR ANALYSIS. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE ANALYSIS. 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.
PRODUCT ANALYSIS: BOTH VALES RETURNED ON 2025-SEP-24 VALVE 1: THE VALVE WAS RECEIVED IN A HEART VALVE RETURN KIT JAR FULLY SUBMERGED IN CLEAR 0.2% GLUTARALDEHYDE SOLUTION. WITH VISUAL EVALUATION THE VALVE SHOWED REMNANTS OF COAGULATED BLOOD. THE VALVE FRAME WAS RECEIVED SLIGHTLY COMPRESSED AT THE INFLOW. AS RECEIVED. ALL LEAFLETS APPEARED TO BE IN A PARTIALLY CLOSED POSITION WITH A GAP BETWEEN THE FREE EDGES. ALL LEAFLETS WERE FLEXIBLE AND SHOWED SIGNS CREASES AND FRAME IMPRINTS. ALL COMMISSURES APPEARED INTACT. ALL SUTURES APPEARED INTACT. THE VALVE WAS SUBMERGED IN A WARM (APPROXIMATELY 37 °C) SALINE BATH, RESULTING IN EXPANSION OF THE FRAME. NO DAMAGES SUCH AS BENDS OR KINKS WERE OBSERVED ON THE FRAME. VALVE 2: THE VALVE WAS RECEIVED IN A HEART VALVE RETURN KIT JAR FULLY SUBMERGED IN CLEAR 0.2% GLUTARALDEHYDE SOLUTION. VISUAL EVALUATION OF THE VALVE NOTED DISCOLORATION WHICH SHOWED EVIDENCE OF BLOOD CONTACT. THE VALVE FRAME WAS RECEIVED SLIGHTLY COMPRESSED AT THE INFLOW. AS RECEIVED, LEAFLETS 1 (L1) AND 2 (L2) WERE IN A CLOSED POSITION WHILE LEAFLET 3 APPEARED PARTIALLY OPEN. ALL LEAFLETS WERE FLEXIBLE AND SHOWED SIGNS CREASES AND FRAME IMPRINTS. ALL COMMISSURES APPEARED INTACT. ALL SUTURES APPEARED INTACT. THE VALVE WAS SUBMERGED IN A WARM (APPROXIMATELY 37 °C) SALINE BATH, RESULTING IN EXPANSION OF THE FRAME. NO DAMAGES SUCH AS BENDS OR KINKS WERE OBSERVED ON THE FRAME. UPDATED DATA: B5, H3, 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.
UPDATED DATA: B5, 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.
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE, A PRE-IMPLANT BALLOON VALVULOPLASTY WAS PERFORMED PER STANDARD PROCEDURE OF THE IMPLANTING PHYSICIAN. OF NOTE, THE ANATOMY HAD MEASURED IN-BETWEEN A 26 MILLIMETER (MM) TRANSCATHETER VALVE AND A 29 MM TRANSCATHETER VALVE, AND THERE WAS ¿VERY LITTLE¿ CALCIUM PRESENT. THE PHYSICIAN ATTEMPTED PLACEMENT OF THE 26 MM VALVE, BUT THE VALVE DISLODGED AORTIC PRIOR TO REACHING 80% DEPLOYMENT FROM THE DCS. THREE PLACEMENT ATTEMPTS OCCURRED WITH THIS 26 MM VALVE. ALL ATTEMPTS HAD THE SAME RESULT WITH THIS VALVE SYSTEM. THIS SYSTEM WAS REMOVED FROM THE PATIENT. A DIFFERENT DCS AND A 29 MM VALVE WERE THEN ATTEMPTED BUT THE SAME ISSUE OCCURRED. DISLODGEMENT OF THE 29 MM VALVE WHILE STILL ATTACHED TO THE DCS WAS OBSERVED. THIS SECOND SYSTEM WAS REMOVED FROM THE PATIENT. AS REPORTED, PATIENT ANATOMY WAS A FACTOR AS THERE WAS ¿VERY LITTLE¿ CALCIUM FOR THE VALVES TO BE HELD IN PLACE. ULTIMATELY, THE PATIENT DID NOT RECEIVE AN IMPLANTED VALVE DURING THIS IMPLANT PROCEDURE. ADDITIONALLY, DURING THIS IMPLANT PROCEDURE COMPLETE HEART BLOCK (CHB) DEVELOPED. A TEMPORARY PACEMAKER WAS REQUIRED AND REMAINED THROUGH HOSPITAL COURSE. THE DAY FOLLOWING THE IMPLANT PROCEDURE A PERMANENT PACEMAKER WAS IMPLANTED. THE CHB EVENT RESOLVED THIS SAME DATE. THE PATIENT WAS DISCHARGED 2 DAYS FOLLOWING THE VALVE IMPLANT. PER THE PHYSICIAN, THIS EVENT WAS RELATED TO THE IMPLANT PROCEDURE, THE ATTEMPTED VALVES, BOTH DCS, AND AN UNSPECIFIED GUIDEWIRE.
ADDITIONAL INFORMATION RECEIVED INDICATED THE COMPLETE HEART BLOCK (CHB) PROLONGED HOSPITALIZATION. THE CHB EVENT RESOLVED WITH SEQUELAE AND WAS REPORTED AS CAUSAL RELATED TO THE IMPLANT PROCEDURE AND VALVE.
APPROXIMATELY 4.5 MONTHS FOLLOWING THE ATTEMPT VALVE IMPLANT A PACEMAKER INTERROGATION WAS PERFORMED WHICH INDICATED THE PACEMAKER DEPENDENCY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268703 | EVOLUT FX DCS | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC IRELAND | D-EVOLUTFX-2329 | 0012896872 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |