EVOLUT FX VALVE
Report
- Report Number
- 9617601-2025-02532
- Event Type
- Malfunction
- Date Received
- November 5, 2025
- Date of Event
- October 30, 2025
- Report Date
- January 28, 2026
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000370626
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID EVOLUTFX-29 (K036117); 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.
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.
PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE DEVICE WAS RECEIVED IN ITS ORIGINAL PRODUCT PACKAGING. THE STATE OF THE JAR SAFETY SEAL WAS BROKEN. DUE TO THE RECEIPT CONDITION, A TORQUE ASSESSMENT TO EVALUATE AGAINST THE ¿DIFFICULT TO OPEN JAR¿ ALLEGATION COULD NOT BE PERFORMED. IT IS POSSIBLE A READING FROM THE TORQUE TESTER WOULD BE UNRELIABLE AS THE JAR HAS BEEN PREVIOUSLY OPENED. THERE WAS NO PRESENCE OF GASKET REMNANTS ON THE RIM OF THE JAR. THERE WAS NO PRESENCE OF CRYSTALLIZED, DRIED GLUTARALDEHYDE ALONG THE THREADS OF THE JAR. THERE WERE LOOSE PIECES OF THE GASKET NOTED ON THE RIM AND OUTSIDE OF THE JAR. THERE WAS THE PRESENCE OF WHITE PARTICULATE IN THE SOLUTION. THERE WAS NO DAMAGE ON THE THREADS OF THE LID. PITS AND PEELING WERE OBSERVED ON THE GASKET. LOOSE PIECES OF GASKET WERE NOT NOTED INSIDE OF THE LID. THE TEMPERATURE INDICATOR WAS NOT ACTIVATED. THE MOLD CAVITY NUMBERS ON THE JAR AND LID WERE 8 AND 2. WHITE PARTICULATE WAS FOUND IN THE JAR AND/OR LID UPON OPENING. 16 SIMILAR COMPLAINTS HAD BEEN COMPLETED, AND FOURIER TRANSFORM INFRARED (FTIR) ANALYSIS WAS PERFORMED TO CONFIRM THE WHITE PARTICULATES WERE FROM THE GASKET INSIDE THE LID. AS A RESULT, NO FURTHER PARTICULATE ANALYSIS IS REQUIRED; A VISUAL INSPECTION USING A MICROSCOPE AT 10X MAGNIFICATION IS SUFFICIENT. THESE PARTICULATES CAN BE TESTED IN THE FUTURE IF NEEDED AS THE RETURNED DEVICES ARE RETAINED FOR 5 YEARS PER THE RETENTION POLICY. CAPA 684613 IS OPENED TO INVESTIGATE THE DIFFICULTY OF JAR TO OPEN COMPLAINTS AND THESE WHITE PARTICULATES FROM THE GASKET IS PART OF THE FAILURE MODE OBSERVED FROM THE RETURNED DEVICES. UPDATED D9. H3. AND 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, E1, 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 WHITE LOOSE PARTICLES WERE VISIBLE ON THE GLASS AFTER OPENING THE JAR CONTAINING TWO DIFFERENT EVOLUTFX-29 VALVES. THERE WAS NO PATIENT INVOLVED.
IT WAS REPORTED THAT WHITE LOOSE PARTICLES WERE VISIBLE ON THE GLASS AFTER OPENING THE JAR CONTAINING TWO DIFFERENT EVOLUTFX-29 VALVES. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT DIFFICULTY OPENING THE VALVE JAR RESULTED IN A WHITE, LOOSE PARTICULATE FROM THE JAR LID SEAL/GASKET. DAMAGE TO THE SEAL WAS PRESUMED AS WHITE PARTICLES WERE STUCK ON THE GASKET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2677155 | EVOLUT FX VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVOLUTFX-29 | 00763000370626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |