EVOLUT PRO PLUS DCS
Report
- Report Number
- 9612164-2025-05363
- Event Type
- Malfunction
- Date Received
- October 31, 2025
- Date of Event
- October 23, 2025
- Report Date
- January 14, 2026
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NPT
- UDI-DI
- 00763000572044
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- 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.
SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME EVOLUT PRO PLUS VALVE; PRODUCT ID: EVPROPLUS-23, (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2025, 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.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE IMPLANTATION WITH THE EVOLUT 23 MILLIMETER VALVE AND ASSOCIATED DELIVERY SYSTEM, A FRAME OVERLAP TO THE SECOND NODE WAS OBSERVED DURING FLUOROSCOPY. SEVERAL RECAPTURES WERE REQUIRED DURING THE DEPLOYMENT PHASE TO OPTIMIZE POSITIONING AND ALIGNMENT OF THE PROSTHESIS WITH THE PATIENT¿S ANATOMY. DURING THE FINAL RELEASE, ONE OF THE VALVE PADDLES APPEARED PARTIALLY ADHERENT TO THE PADDLE ATTACHMENT POCKETS OF THE DELIVERY SYSTEM, RESULTING IN DIFFICULT AND DELAYED DETACHMENT. THE OPERATOR ATTEMPTED TO PUSH THE DELIVERY SYSTEM AND CLOSE THE CAPSULE, BUT THESE ACTIONS WERE INEFFECTIVE; AFTER REPEATED ATTEMPTS, FULL DETACHMENT WAS ACHIEVED WITH NO APPARENT STRUCTURAL CONSEQUENCES TO THE DEVICE. THE PIG TAIL RECAPTURE AT THE NON-CORONARY CUSP WAS CHALLENGING, LIKELY DUE TO THE SMALL ANATOMY OF THE AORTIC ROOT AND LIMITED MANEUVERING SPACE. DESPITE THESE PROCEDURAL DIFFICULTIES, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A GOOD HEMODYNAMIC OUTCOME AND SATISFACTORY VALVE POSITIONING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAPSULE RESPONDED APPROPRIATELY TO ACTUATOR ROTATION THROUGHOUT THE DEPLOYMENT. MORE THAN THREE RECAPTURES WERE PERFORMED TO OPTIMIZE VALVE POSITIONING BEFORE THE FINAL RELEASE. MINOR DIFFICULTY WAS NOTED DURING RECAPTURE, PARTICULARLY DUE TO THE LIMITED SPACE WITHIN THE AORTIC ROOT, BUT THE VALVE WAS SUCCESSFULLY RECAPTURED EACH TIME. A SINGLE DEPLOYMENT WAS COMPLETED AFTER THE POSITIONING WAS OPTIMIZED THROUGH MULTIPLE RECAPTURES. THE PATIENT'S ANATOMY WAS REPORTED TO CONTRIBUTE TO THE DEPLOYMENT ISSUE AS COMPUTED TOMOGRAPHY (CT) ANALYSIS SHOWING A SMALL, CALCIFIED AORTIC ROOT WITH A NARROW AND PARTIALLY CALCIFIED SINOTUBULAR JUNCTION (STJ). A SMALL CALCIUM DEPOSIT WAS ALSO NOTED BELOW THE LEFT CORONARY CUSP (LCC). THE LEFT VENTRICULAR HYPERTROPHY AND THE LIMITED SPACE WITHIN THE ROOT MAY HAVE CONTRIBUTED TO THE CHALLENGES ENCOUNTERED DURING VALVE RELEASE AND PIGTAIL RECAPTURE.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE IMPLANTATION WITH THE EVOLUT 23 MILLIMETER VALVE AND ASSOCIATED DELIVERY SYSTEM, A FRAME OVERLAP TO THE SECOND NODE WAS OBSERVED DURING FLUOROSCOPY. SEVERAL RECAPTURES WERE REQUIRED DURING THE DEPLOYMENT PHASE TO OPTIMIZE POSITIONING AND ALIGNMENT OF THE PROSTHESIS WITH THE PATIENT¿S ANATOMY. DURING THE FINAL RELEASE, ONE OF THE VALVE PADDLES APPEARED PARTIALLY ADHERENT TO THE PADDLE ATTACHMENT POCKETS OF THE DELIVERY SYSTEM, RESULTING IN DIFFICULT AND DELAYED DETACHMENT. THE OPERATOR ATTEMPTED TO PUSH THE DELIVERY SYSTEM AND CLOSE THE CAPSULE, BUT THESE ACTIONS WERE INEFFECTIVE; AFTER REPEATED ATTEMPTS, FULL DETACHMENT WAS ACHIEVED WITH NO APPARENT STRUCTURAL CONSEQUENCES TO THE DEVICE. THE PIG TAIL RECAPTURE AT THE NON-CORONARY CUSP WAS CHALLENGING, LIKELY DUE TO THE SMALL ANATOMY OF THE AORTIC ROOT AND LIMITED MANEUVERING SPACE. DESPITE THESE PROCEDURAL DIFFICULTIES, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A GOOD HEMODYNAMIC OUTCOME AND SATISFACTORY VALVE POSITIONING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1715278 | EVOLUT PRO PLUS DCS | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC IRELAND | D-EVPROP23-29 | 0013025873 | 00763000572044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |