EVOLUT PRO PLUS VALVE
Report
- Report Number
- 9617601-2025-01816
- Event Type
- Malfunction
- Date Received
- October 6, 2025
- Date of Event
- October 2, 2025
- Report Date
- November 25, 2025
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID: D-EVPROP34 (LOT: 0012873638); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID: L-EVPROP34 (LOT: 0012497770); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID: EVPROPLUS-34 (K057078); 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.
UPDATED DATA: H2 H3 H6. IMAGE REVIEW: AN INCOMPLETE SET OF INTRAPROCEDURAL FLUOROSCOPIC IMAGES WAS PROVIDED FOR REVIEW OF THE EVENT. PATIENT¿S EXECUTIVE SUMMARY WAS PROVIDED FOR ANATOMICAL REVIEW. PATIENT ANNULUS PERIMETER MEASURED 84.6 MILLIMETER (MM) WITH A PERIMETER DERIVED DIAMETER OF 26.9MM SUGGESTING A 34MM EVOLUT. THERE WAS PROTRUDING CALCIFICATION IN THE AORTIC ANNULUS EXTENDING TO THE LEFT VENTRICULAR OUTFLOW TRACK AND SIGNIFICANT LEAFLET CALCIFICATION. FLUOROSCOPIC VALVE LOAD INSPECTION OF THE FIRST VALVE WAS NOT INCLUDED THUS IT IS NOT POSSIBLE TO VALIDATE A GOOD LOAD. HOWEVER, A MISLOAD WAS NOT REPORTED. PRE BALLOON AORTIC VALVULOPLASTY WAS PERFORMED PRIOR TO THE VALVE IMPLANT ATTEMPT. IT WAS REPORTED THAT THE VALVE WAS RECAPTURED THREE TIMES RESULTING IN AN INFOLD. THE DEPLOYMENT ATTEMPTS WERE NOT INCLUDED IN THE DATASET. AN INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW. INFOLDING COULD OCCUR DUE TO 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. EVIDENCE SUPPORTS THAT THE INFOLDED VALVE WAS RECAPTURED, REMOVED AND A NEW VALVE WAS LOADED. FLUOROSCOPIC VALVE LOAD INSPECTION OF THE NEW VALVE VALIDATED A GOOD LOAD. THE VALVE WAS THEN DEPLOYED JUST PRIOR TO THE POINT OF NO RECAPTURE, AND DEPTH ASSESSMENT ON THE LEFT CORONARY CUSP APPEARED TO BE 0MM IN A LEFT ANTERIOR OBLIQUE (LAO) VIEW. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), THE RECOMMENDED TARGET DEPTH IS 3 MM RELATIVE TO THE VALVE ANNULUS. IF THE IMPLANT DEPTH IS <(><<)>1 MM OR >5 MM, CONSIDER RECAPTURE. THE VALVE WAS RECAPTURED, AND SUBSEQUENT DEPLOYMENT ATTEMPT RESULTED IN AN INFOLD. EVIDENCE SUPPORTS THAT THE INFOLDED VALVE WAS RELEASED AND EVEN THOUGH THE INFOLD APPEARED TO BE LESS SIGNIFICANT, IT WAS STILL PRESENT. CONSEQUENTLY, A POST IMPLANT DILATATION WAS PERFORMED WHICH RESOLVED THE INFOLD AND NO EVIDENCE OF AORTIC REGURGITATION/PARAVALVULAR LEAK. 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.
THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: BRAND NAME: EVOLUTPROPLUS DELIVERY CATHETER SYSTEM (DCS), PRODUCT ID: D-EVPROP34, LOT: 0012873638, USE BY DATE: 2027-06-17, UDI: (B)(4). UPDATED: A4, B5, H6, H11. 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 HEART VALVE PROCEDURE, A PRE-DILATION WAS PERFORMED WITH A 23 X 40 MILLIMETER NON-COMPLIANT BALLOON. UPON LOADING THE VALVE, THE VALVE INFOLDED HOWEVER DID NOT EXCEED THE 4TH NODE. THE VALVE WAS IMPLANTED IN A CUSP-OVERLAP VIEW. THE VALVE WAS DEPLOYED AND RECAPTURED THREE TIMES. AFTER THE THIRD RECAPTURE, JUST BEFORE RELEASE, COMPLETE INFOLDING OF THE VALVE WAS OBSERVED IN THE LEFT ANTERIOR OBLIQUE (LAO) VIEW, PROMPTING RECAPTURE AND REMOVAL OF THE ENTIRE DEVICE. A NEW VALVE WAS LOADED, WITH INFOLDING UP TO THE SECOND NODE, AND IMPLANTED IN A CUSP-OVERLAP VIEW. THE VALVE WAS DEPLOYED AND RECAPTURED. DURING THE SECOND DEPLOYMENT, AN INFOLDING LINE WAS IDENTIFIED IN THE LAO VIEW, NOT EXCEEDING TWO RHOMBUSES. THE DECISION WAS MADE TO RELEASE AND POST-DILATE WITH A 25 X 40 MILLIMETER BALLOON, WHICH RESULTED IN THE DISAPPEARANCE OF THE INFOLDING. A COMMISSURAL ALIGNMENT TECHNIQUE WAS USED, AND THE IMPLANT DEPTH IN THE NON-CORONARY CUSP WAS 3 MILLIMETERS. THE CALCIFIED ANATOMY OF THE VALVE WAS IDENTIFIED AS A DETERMINING FACTOR IN THE FOLDING OF BOTH VALVES. THE PHYSICIAN WAS CONSULTED AFTER IMPLANTATION AND AGREED THAT A MORE AGGRESSIVE IMPLANTATION SHOULD HAVE BEEN USED. THE PATIENT REMAINED STABLE.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE, A PRE-DILATION WAS PERFORMED WITH A 23 X 40 MILLIMETER NON-COMPLIANT BALLOON. UPON LOADING THE VALVE, THE VALVE INFOLDED HOWEVER DID NOT EXCEED THE 4TH NODE. THE VALVE WAS IMPLANTED IN A CUSP-OVERLAP VIEW. THE VALVE WAS DEPLOYED AND RECAPTURED THREE TIMES. AFTER THE THIRD RECAPTURE, JUST BEFORE RELEASE, COMPLETE INFOLDING OF THE VALVE WAS OBSERVED IN THE LEFT ANTERIOR OBLIQUE (LAO) VIEW, PROMPTING RECAPTURE AND REMOVAL OF THE ENTIRE DEVICE. A NEW VALVE WAS LOADED, WITH INFOLDING UP TO THE SECOND NODE, AND IMPLANTED IN A CUSP-OVERLAP VIEW. THE VALVE WAS DEPLOYED AND RECAPTURED. DURING THE SECOND DEPLOYMENT, AN INFOLDING LINE WAS IDENTIFIED IN THE LAO VIEW, NOT EXCEEDING TWO RHOMBUSES. THE DECISION WAS MADE TO RELEASE AND POST-DILATE WITH A 25 X 40 MILLIMETER BALLOON, WHICH RESULTED IN THE DISAPPEARANCE OF THE INFOLDING. A COMMISSURAL ALIGNMENT TECHNIQUE WAS USED, AND THE IMPLANT DEPTH IN THE NON-CORONARY CUSP WAS 3 MILLIMETERS. THE CALCIFIED ANATOMY OF THE VALVE WAS IDENTIFIED AS A DETERMINING FACTOR IN THE FOLDING OF BOTH VALVES. THE PHYSICIAN WAS CONSULTED AFTER IMPLANTATION AND AGREED THAT A MORE AGGRESSIVE IMPLANTATION SHOULD HAVE BEEN USED. THE PATIENT REMAINED STABLE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE FIRST VALVE WAS RECAPTURED THREE TIMES BECAUSE THE POSITION WAS UNSTABLE (IT WAS DEEPENING OR DISLODGING) AND WAS NOT AT THE CORRECT DEPTH (BETWEEN 1MM AND 5 MM). THE SECOND VALVE WAS RECAPTURED FOR THE SAME REASONS AS IT REMAINED TOO DEEP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2654198 | EVOLUT PRO PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVPROPLUS-34 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male |