EVOLUT PRO PLUS VALVE
Report
- Report Number
- 2025587-2025-04963
- Event Type
- Malfunction
- Date Received
- July 12, 2025
- Date of Event
- July 3, 2025
- Report Date
- October 6, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- UDI-DI
- 00763000655440
- 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-EVPROP34 (LOT: 0012756386); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID L-EVPROP34 (LOT: 0012710782); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVPROPLUS-34 (J253805); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVPROP34 (0012792506); PRODUCT TYPE: 0195-HEART VALVES. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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.
IMAGE REVIEW: PRE-IMPLANT COMPUTED TOMOGRAPHY (CT) IMAGING PROVIDED FROM (B)(6) 2025. AORTIC VALVE IS TRILEAFLET. AORTIC VALVE LEAFLETS APPEAR MILDLY CALCIFIED. ANNULUS PERIMETER IS 85.9 MM WITH A PERIMETER DERIVED DIAMETER OF 27.3 MM SUGGESTING A 34 MM EVOLUT. LEFT VENTRICULAR OUTFLOW TRACT (LVOT) MEASURES A PERIMETER OF 79.2 MM AND PERIMETER DERIVED DIAMETER OF 25.2 MM CONSISTENT WITH 34 MM EVOLUT. SINUS OF VALSALVA (SOV) DIAMETERS ARE WITHIN RECOMMENDED RANGE. ALL SINUS AND CORONARY HEIGHTS ARE WITHIN RECOMMENDED RANGE. AORTIC ROOT ANGULATION IS 61°. INTRAPROCEDURAL FLUOROSCOPIC IMAGES WERE PROVIDED FOR REVIEW FOR THIS EVENT. FLUOROSCOPY VALVE LOAD INSPECTION WAS PERFORMED AND A MISLOAD APPEARED TO BE PRESENT BY OVERLAP TO NODE 4. PER MEDTRONIC BEST PRACTICES, OVERLAP PRIOR TO NODE 4 IS CONSIDERED A GOOD LOAD; OVERLAP AT NODE 4 AND BEYOND IS CONSIDERED A MISLOAD. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), IF A MISLOAD IS DETECTED, DO NOT ATTEMPT TO RELOAD THE BIOPROSTHESIS. DISCARD THE ENTIRE SYSTEM. THE VALVE, CATHETER, LOADING SYSTEM, LOADING TRAY, AND SALINE MUST ALL BE REPLACED WITH NEW STERILE COMPONENTS. HOWEVER, THE MISLOADED VALVE WAS USED FOR THE PROCEDURE. A PRE BALLOON AORTIC VALVULOPLASTY WAS PERFORMED PRIOR TO THE VALVE IMPLANT ATTEMPT. DURING THE DEPLOYMENT, AN INFOLD WAS EVIDENT. THE VALVE WAS RECAPTURED, AND DEPLOYMENT WAS RE-ATTEMPTED RESULTING IN A PERSISTENT INFOLD. THE INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW. INFOLDING COULD OCCUR DUE A MISLOADED VALVE, ANATOMICAL CHARACTERISTICS SUCH AS CALCIUM, AND RECAPTURES. ACCORDING TO MEDTRONIC BEST PRACTICES, IF AN INFOLD IS IDENTIFIED, THE VALVE SHOULD BE RECAPTURED, REMOVED FROM THE BODY, AND DISCARDED. NEW STERILE COMPONENTS MUST BE USED. FURTHERMORE, RECAPTURING AN INFOLDED VALVE WILL NOT RESOLVE THE INFOLD. IT WAS REPORTED THAT THE SAME VALVE WAS RE-LOADED, AND FLUOROSCOPIC CHECK SHOWED A GOOD LOAD. HOWEVER, AS STATED IN THE IFU, IF A BIOPROSTHESIS AND CATHETER HAVE BEEN REMOVED FROM A PATIENT, DISPOSE OF BOTH THE BIOPROSTHESIS AND CATHETER; DO NOT ATTEMPT TO REUSE EITHER COMPONENT. BOTH THE BIOPROSTHESIS AND CATHETER MUST BE REPLACED WITH NEW STERILE COMPONENTS. DEPLOYMENT ATTEMPT WITH THE SAME VALVE RESULTED IN ANOTHER INFOLD. SUBSEQUENTLY, THE INFOLDED VALVE WAS REMOVED AND REPLACED WITH A NEW VALVE AND SYSTEM. FLUOROSCOPY VALVE LOAD INSPECTION OF THE NEW VALVE WAS PERFORMED AND A MISLOAD APPEARED TO BE PRESENT BY OVERLAP TO NODE 4 . DEPLOYMENT ATTEMPT OF THE NEW VALVE RESULTED IN ANOTHER INFOLD, MOST LIKELY DUE TO THE MISLOAD. FURTHER ATTEMPTS TO IMPLANT A VALVE WERE ABORTED. 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.
UPDATED DATA: 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 RPA LAB, LOOSE IN A BAG ALONGSIDE THE DELIVERY SYSTEM. THE VALVE WAS FORWARDED TO THE SANTA ANA RPA LAB IN A RETURN KIT JAR SUBMERGED IN CLEAR 0.2% GLUTARALDEHYDE SOLUTION. THE VALVE WAS RECEIVED SEVERELY DEHYDRATED SHOWING EVIDENCE OF BLOOD CONTACT. AS RECEIVED, LEAFLET 1 AND LEAFLET 2 APPEARED PARTIALLY CLOSED WHILE LEAFLET 3 APPEARED OPEN. ALL LEAFLETS AND VALVE SKIRT APPEARED SEVERELY DEHYDRATED WITH A TRANSLUCENT APPEARANCE. LEAFLETS WERE STIFF WITH MODERATE FLEXIBILITY. ALL COMMISSURES APPEARED INTACT. ALL SUTURES APPEARED INTACT. THERE WAS NO EVIDENCE OF BENDS OR KINKS TO THE FRAME. DUE TO THE RETURNED CONDITION OF THE VALVE, A DEPLOYMENT SIMULATION COULD NOT BE PERFORMED. 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.
UPDATED DATA: B5. A SECOND PARAGRAPH WAS ADDED. H10. CORRECTED DATA: ADDITIONAL CODES. ANNEX F CODE FOR NO HEALTH CONSEQUENCE OR IMPACT WAS REPLACED WITH ABSENCE OF TREATMENT. 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 A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE WITH AN EVOLUT PRO+ 34 MILLIMETER VALVE, INITIAL PREDILATATION WAS PERFORMED USING A 23 MILLIMETER SEMI-COMPLIANT BALLOON. AT THE FIRST IMPLANTATION ATTEMPT, THE VALVE EXHIBITED INFLO-OVERLAP UP TO THE THIRD NODE UNDER FLUOROSCOPY AND APPEARED INFOLDED UPON DEPLOYMENT. THE VALVE WAS RECAPTURED, AND A SECOND DEPLOYMENT ATTEMPT AGAIN RESULTED IN INFOLDING. THE DELIVERY SYSTEM WAS REMOVED TO ALLOW REMOUNTING OF THE SAME VALVE. AFTER PASSING FLUOROSCOPIC INSPECTION, THE VALVE WAS REDEPLOYED; HOWEVER, AT APPROXIMATELY 80% DEPLOYMENT, A POP-OUT OCCURRED, FOLLOWED BY ADDITIONAL INFOLDING DURING RECAPTURE. THE MEDICAL TEAM DECIDED TO REPLACE BOTH THE VALVE AND THE DELIVERY SYSTEM. UPON MOUNTING, THE NEW VALVE SHOWED INFLO-OVERLAP NEAR THE FOURTH NODE, BUT THE DECISION WAS MADE TO PROCEED WITH DEPLOYMENT. THE VALVE REMAINED CONSTRAINED AND INFOLDED AFTER OPENING. A FURTHER REMOUNTING OF THE SAME PROSTHESIS WAS PERFORMED, BUT THE SUBSEQUENT DEPLOYMENT ALSO RESULTED IN INFOLDING. DUE TO REPEATED DEPLOYMENT FAILURE, THE PROCEDURE WAS ULTIMATELY ABORTED. FLUOROSCOPIC INSPECTION WAS CONDUCTED THROUGHOUT THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE WITH AN EVOLUT PRO+ 34MM VALVE, INITIAL PREDILATATION WAS PERFORMED USING A 23MM SEMI-COMPLIANT BALLOON. AT THE FIRST IMPLANTATION ATTEMPT, THE VALVE EXHIBITED INFLO-OVERLAP UP TO THE THIRD NODE UNDER FLUOROSCOPY AND APPEARED INFOLDED UPON DEPLOYMENT. THE VALVE WAS RECAPTURED, AND A SECOND DEPLOYMENT ATTEMPT AGAIN RESULTED IN INFOLDING. THE DELIVERY SYSTEM WAS REMOVED TO ALLOW REMOUNTING OF THE SAME VALVE. AFTER PASSING FLUOROSCOPIC INSPECTION, THE VALVE WAS REDEPLOYED; HOWEVER, AT APPROXIMATELY 80% DEPLOYMENT, A POP-OUT OCCURRED, FOLLOWED BY ADDITIONAL INFOLDING DURING RECAPTURE. THE MEDICAL TEAM DECIDED TO REPLACE BOTH THE VALVE AND THE DELIVERY SYSTEM. UPON MOUNTING, THE NEW VALVE SHOWED INFLO-OVERLAP NEAR THE FOURTH NODE, BUT THE DECISION WAS MADE TO PROCEED WITH DEPLOYMENT. THE VALVE REMAINED CONSTRAINED AND INFOLDED AFTER OPENING. A FURTHER REMOUNTING OF THE SAME PROSTHESIS WAS PERFORMED, BUT THE SUBSEQUENT DEPLOYMENT ALSO RESULTED IN INFOLDING. DUE TO REPEATED DEPLOYMENT FAILURE, THE PROCEDURE WAS ULTIMATELY ABORTED. FLUOROSCOPIC INSPECTION WAS CONDUCTED THROUGHOUT THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT A PROCEDURAL DELAY AND, IT WAS NOTED AFTER TWO HOURS, THE VALVE IMPLANT PROCEDURE WAS ABORTED. PER THE PHYSICIAN, THE PATIENT'S ANATOMY WAS UNREMARKABLE; THERE WAS NO ANOMALOUS PATIENT ANATOMY TO CONTRIBUTE TO THE INFOLD THAT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679018 | EVOLUT PRO PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVPROPLUS-34 | 00763000655440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | SEE H11... |