EVOLUT PRO PLUS VALVE
Report
- Report Number
- 9617601-2025-02192
- Event Type
- Injury
- Date Received
- October 23, 2025
- Date of Event
- October 20, 2025
- Report Date
- November 25, 2025
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000655433
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID D-EVPROP34 (LOT: 0012443480); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID L-EVPROP34 (LOT: 0012362256); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID L-EVPROP23-29 (LOT: 0012702011); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVPROP23-29 (LOT: 0012799577); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVPROP23-29 (LOT: 0012799577); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID SENSH1828W (LOT: P2F25D0065); PRODUCT TYPE: 0199-INTRODUCER; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID EVPROPLUS-34 (J340905); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVPROPLUS-29 (K035344); 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. 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: ONE INTRAPROCEDURAL FLUOROSCOPIC IMAGE WAS PROVIDED FOR REVIEW. THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. THE ONLY AVAILABLE IMAGE WAS OBTAINED PRIOR TO VALVE IMPLANTATION AND DEMONSTRATES A PIGTAIL CATHETER ACROSS THE AORTIC VALVE AND POSITIONED IN THE LEFT VENTRICLE. NO ADDITIONAL SUPPORTING DOCUMENTATION OR IMAGING WAS PROVIDED; CONSEQUENTLY, THIS REVIEW REMAINS INCONCLUSIVE. 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.
UPDATED: B5, H6. CORRECTED: D4, G1. 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: B5. 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 OF THE 34 MM TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-BALLOON DILATION WAS PERFORMED WITH A 25X50 MM BALLOON. THE VALVE WAS LOADED SUCCESSFULLY AND VERIFIED VIA FLUOROSCOPY. THE VALVE WAS DEPLOYED AND AN INFOLD WAS NOTED. THE VALVE WAS RECAPTURED AND REMOVED. A 29 MM VALVE WAS DETERMINED TO BE IMPLANTED. THE PATIENT BECAME UNSTABLE AND THERE WAS NO TIME TO FURTHER PRE-DILATE. THE VALVE WAS DEPLOYED AND AN INFOLD WAS OBSERVED. THE PATIENT WENT INTO CARDIAC ARREST. IT WAS DETERMINED TO RELEASE THE VALVE AND AN EMERGENCY DILATION WAS PERFORMED. THE PATIENT RETURNED TO NORMAL RHYTHM HOWEVER THE VALVE DISLODGED. A SECOND 29 MM VALVE WAS IMPLANTED IN A GOOD POSITION. MILD-MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. NO TREATMENT WAS PERFORMED AS THE PATIENT WAS STABLE.
ADDITIONAL INFORMATION WAS RECEIVED THAT CARDIOPULMONARY RESUSCITATION MEASURES WERE PERFORMED FOR THE CARDIAC ARREST.
IT WAS REPORTED THAT DURING THE IMPLANT OF THE 34 MM TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-BALLOON DILATION WAS PERFORMED WITH A 25X50 MM BALLOON. THE VALVE WAS LOADED SUCCESSFULLY AND VERIFIED VIA FLUOROSCOPY. THE VALVE WAS DEPLOYED AND AN INFOLD WAS NOTED. THE VALVE WAS RECAPTURED AND REMOVED. A 29 MM VALVE WAS DETERMINED TO BE IMPLANTED. THE PATIENT BECAME UNSTABLE AND THERE WAS NO TIME TO FURTHER PRE-DILATE. THE VALVE WAS DEPLOYED AND AN INFOLD WAS OBSERVED. THE PATIENT WENT INTO CARDIAC ARREST. IT WAS DETERMINED TO RELEASE THE VALVE AND AN EMERGENCY DILATION WAS PERFORMED. THE PATIENT RETURNED TO NORMAL RHYTHM HOWEVER THE VALVE DISLODGED. A SECOND 29 MM VALVE WAS IMPLANTED IN A GOOD POSITION. MILD-MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. NO TREATMENT WAS PERFORMED AS THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE NATIVE VALVE WAS EXTREMELY CALCIFIED AND BICUSPID. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFOLD IN THE VALVE FRAME WAS FIRST NOTICED DURING FIRST DEPLOYMENT. A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD. PER THE PHYSICIAN, THE NATIVE BICUSPID VALVE CONTRIBUTED TO THE INFOLD. THE FIRST VALVE 29 MM VALVE WAS RELEASED IN SHALLOW MODE. DURING POST-DILATION, THE VALVE MIGRATED BUT IT WAS NOT ATTRIBUTED DIRECTLY TO THE BALLOON DILATION. TREATMENT WAS PROVIDED FOR THE CARDIAC ARREST.
IT WAS REPORTED THAT DURING THE IMPLANT OF THE 34 MM TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-BALLOON DILATION WAS PERFORMED WITH A 25X50 MM BALLOON. THE VALVE WAS LOADED SUCCESSFULLY AND VERIFIED VIA FLUOROSCOPY. THE VALVE WAS DEPLOYED AND AN INFOLD WAS NOTED. THE VALVE WAS RECAPTURED AND REMOVED. A 29 MM VALVE WAS DETERMINED TO BE IMPLANTED. THE PATIENT BECAME UNSTABLE AND THERE WAS NO TIME TO FURTHER PRE-DILATE. THE VALVE WAS DEPLOYED AND AN INFOLD WAS OBSERVED. THE PATIENT WENT INTO CARDIAC ARREST. IT WAS DETERMINED TO RELEASE THE VALVE AND AN EMERGENCY DILATION WAS PERFORMED. THE PATIENT RETURNED TO NORMAL RHYTHM HOWEVER THE VALVE DISLODGED. A SECOND 29 MM VALVE WAS IMPLANTED IN A GOOD POSITION. MILD-MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. NO TREATMENT WAS PERFORMED AS THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE NATIVE VALVE WAS EXTREMELY CALCIFIED AND BICUSPID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1930419 | EVOLUT PRO PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVPROPLUS-29 | 00763000655433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Male | Life Threatening| R |