EVOLUT FX VALVE
Report
- Report Number
- 2025587-2024-03148
- Event Type
- Malfunction
- Date Received
- May 29, 2024
- Date of Event
- May 27, 2024
- Report Date
- July 30, 2024
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- 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 D-EVOLUTFX-34 (LOT: 0012150019); PRODUCT TYPE: 0195-HEART VALVES PRODUCT ID D-EVOLUTFX-34 (LOT: 0012174630); PRODUCT TYPE: 0195-HEART VALVES PRODUCT ID EVOLUTFX-34 (J173857); 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.
PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE VALVE WAS RECEIVED IN ITS ORIGINAL CONTAINER JAR SUBMERGED IN CLOUDY SOLUTION. THE VALVE WAS DISCOLORED SHOWING EVIDENCE OF BLOOD CONTACT. THE FRAME APPEARED TO BE IN A PARTIALLY CRIMPED STATE. AS RECEIVED, ALL LEAFLETS WERE PARTIALLY WAVY IN A CLOSED POSITION WITH A GAP AT THE POINT OF COAPTATION. THE LEAFLETS WERE FLEXIBLE AND INTACT. ALL LEAFLETS EXHIBITED SIGNS OF MINOR CREASES AND FRAME IMPRINTS. ALL COMMISSURES WERE INTACT. THE VALVE WAS SUBMERGED IN BODY-TEMP (APPROXIMATE 37 CELSIUS) SALINE. THE FRAME EXPANDED TO FULL DILATION. NO KINKS OR DISTORTIONS WERE NOTED ON THE FRAME. THE VALVE WAS PLACED IN A COLD SALINE BATH TO PERFORM LOADING SIMULATION PER INSTRUCTIONS FOR USE (IFU). UPON LOADING, FRAME PADDLES WERE SEATED WITHIN THE PADDLE ATTACHMENT POCKETS WITHOUT ISSUE. THE CAPSULE WAS ADVANCED COVERING THE FRAME PADDLES AND OUTFLOW CROWN STRUTS. THE CAPSULE WAS ADVANCED UNTIL THE CAPSULE GUIDE TUBE COVERED THE COMMISSURE PAD OF THE VALVE. THE INFLOW CONE WAS ADVANCED TO CRIMP THE INFLOW PORTION OF THE VALVE; NO ISSUES WERE NOTED. THE CAPSULE WAS FULLY ADVANCED OVER THE VALVE. NO VISUAL OR TACTILE ANOMALIES WERE NOTED DURING THE LOADING SIMULATION. TO EVALUATE AGAINST THE REPORTED EVENT OF INFOLDING, THE VALVE WAS DEPLOYED IN A BODY-TEMP (APPROXIMATE 37 CELSIUS) SALINE BATH. THE DEPLOYMENT KNOB WAS ROTATED TO EXPOSE THE VALVE AT THE INFLOW; NO ANOMALIES WERE OBSERVED. THE VALVE CONTINUED TO BE DEPLOYED UP TO THE POINT OF NO RECAPTURE WITHOUT ISSUE. THE VALVE WAS FULLY DEPLOYED. NO ANOMALIES WERE NOTED DURING THE DEPLOYMENT SIMULATION. IMAGE REVIEW: FOUR STATIC IMAGES AND FIFTEEN MEDIA FILES WERE PROVIDED FOR REVIEW. THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. FLUOROSCOPIC VALVE LOAD INSPECTION WAS PERFORMED AND A MISLOAD WAS PRESENT BY OVERLAP TO NODE 4. HOWEVER, A MISLOAD WAS NOT IDENTIFIED AND THE VALVE WAS ATTEMPTED TO BE IMPLANTED RESULTING IN AN INFOLD, WHICH WAS CONFIRMED ON THE PROVIDED IMAGES. IT WAS REPORTED THAT THE INFOLDED VALVE WAS RECAPTURED AND REMOVED. SUBSEQUENTLY, A NEW FLUOROSCOPIC VALVE LOAD INSPECTION WAS PERFORMED, AND ANOTHER MISLOAD WAS PRESENT BY OVERLAP TO NODE 4, CONFIRMED ON THE PROVIDED IMAGES. PER THE IMAGE REVIEW, THIS MISLOAD RESULTED IN ANOTHER INFOLD DURING DEPLOYMENT. 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. THE VALVE WAS DEPLOYED ON THE STERILE FIELD AND THE EVIDENCE PROVIDED CONFIRMED AN INFOLD. IT WAS REPORTED THAT A THIRD VALVE WAS USED AND SUCCESSFULLY IMPLANTED. UPDATED 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 B.5 AND IMF CODE. 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 RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE (B)(6) WAS LOADED AND FLUOROSCOPIC LOADING CHECK SHOWED A CROWN OVERLAP UNTIL NODE 4, WHICH WAS ACCEPTED FOR USE. WHILE ATTEMPTING TO IMPLANT THE VALVE, SEVERE INFOLDING WAS SEEN SO THAT THE VALVE WOULD BE UNABLE TO DEVELOP PROPERLY. THE VALVE WAS IMMEDIATELY RECAPTURED AND REMOVED FROM THE PATIENT. A NEW VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE USED TO ATTEMPT IMPLANT AGAIN. THE SECOND VALVE (B)(6) WAS CHECKED WITH FLUOROSCOPY AND AGAIN, AN OVERLAP UP TO NODE 4 WAS VISIBLE, WHICH WAS DEEMED ACCEPTABLE FOR USE. THE FIRST POSITIONING WAS CONSIDERED TOO LOW, SO THE VALVE WAS RECAPTURED AND REPOSITIONED. AFTER ACHIEVING A MORE SUITABLE POSITION, INFOLDING OF THE VALVE WAS SEEN BEFORE FINAL RELEASE. THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A THIRD VALVE (B)(6) WAS SUCCESSFULLY IMPLANTED WITH NO INFOLDING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED THAT A PROCEDURE DELAY OCCURRED AS A RESULT OF THE INFOLDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1940252 | EVOLUT FX VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTFX-34 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | SEE H11... |