BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX VALVE

    MDR report key: 19791466 · Received July 22, 2024

    Report

    Report Number
    2025587-2024-04076
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    May 3, 2024
    Report Date
    September 30, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE DEVICE WAS RECEIVED VIA FEDEX IN ITS ORIGINAL PRODUCT PACKAGING. THE SAFETY SEAL ON THE JAR WAS RECEIVED BROKEN. THE JAR WAS NOT EVALUATED FOR DIFFICULTY TO OPEN ALLEGATION BECAUSE IT HAD ALREADY BEEN OPENED. THE JAR WAS OPENED, AND WHITE PARTICULATES WERE FOUND INSIDE THE JAR. PIECES OF GASKET MATERIAL WAS OBSERVED ON THE RIM OF THE JAR. THE GASKET AROUND THE JAR LID SHOWED DAMAGE. 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.

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ACCORDING TO THE MANUFACTURING ASSESSMENT AND INVESTIGATION, ELEVEN POTENTIAL ROOT CAUSES WERE IDENTIFIED, HOWEVER NONE COULD BE CONFIRMED FROM THE AVAILABLE INFORMATION. THE DEVICE COMPLIED THROUGH ALL MANUFACTURING PROCESS REQUIREMENTS AND INSPECTION CRITERIA WERE MET. THE CURRENT MANUFACTURING PROCESS IS ROBUST AND HAS PREVENTION AND DETECTION CONTROLS TO AVOID AND DETECT THE CONDITION OF THE COMPLAINT. TWO PRIMARY PACKAGING IMPROVEMENTS WERE IMPLEMENTED. ONE IMPROVEMENT IS TO PREVENT THE VALVE FROM BEING INCORRECTLY TORQUED. TO PREVENT RISK OF EXTERNAL CONTAMINATION FROM THE TRANSPORT OF PACKAGED VALVES, THE TORQUE OPERATION MUST BE PERFORMED INSIDE THE FLOW HOOD. THIS IMPLEMENTATION ALLOWS PERFORMING THE TORQUE OPERATION IN ONE MOVEMENT, PREVENTING AN INCORRECTLY SEALED JAR OR INCORRECT TORQUE. THE SECOND IMPROVEMENT WAS RELATED TO THE SEMI-AUTOMATED SOLUTION DISPENSER TO PREVENT OVERFILLING OF THE STERILANT SOLUTION. THIS SEMI-AUTOMATED SOLUTION DISPENSER IS INTENDED TO FILL THE PACKAGING JAR USING A PEDAL IN ORDER TO START THE FILLING PROCESS AND THE EQUIPMENT WILL AUTOMATICALLY STOP FILLING ONCE THE REQUIRED SOLUTION LEVEL IS ACHIEVED. THIS PROCESS IMPROVEMENT CONTRIBUTES TO LOW-HUMAN DEPENDENCY TO PROPERLY FILL UP THE VALVE CONTAINER WITH STERILANT SOLUTION AT THE REQUIRED LEVEL, LEADING TO REDUCED OCCURRENCE FOR POTENTIAL ISSUES RELATED TO THE LID, SEAL, AND JAR, SUCH AS THE JAR WAS NOT FILLED UP WITH THE SPECIFIED VOLUME OF PACKAGING SOLUTION. THIS EVENT DOES NOT INDICATE DEVICE MISUSE. THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. MEDTRONIC WILL CONTINUE TO MONITOR FOR FUTURE OCCURRENCES AND TRENDS. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (J152879), THE JAR WAS DIFFICULT TO OPEN. UPON OPENING THE JAR, PIECE OF THE JAR SEAL WERE OBSERVED FLOATING IN THE FLUID. THE VALVE WAS NOT USED. A SECOND VALVE (J152656) WAS LOADED ONTO THE DELIVERY CATHETER SYSTEM (DCS) AND THE VALVE CHECK SHOWED AN INFOLD TO THE 3RD NODE. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED THREE TIMES WITH A 22 MILLIMETER (MM) NON-MEDTRONIC BALLOON. THE VALVE WAS DEPLOYED IN A GOOD POSITION AND APPEARED CONSTRICTED. THE VALVE WAS PARTIALLY RECAPTURED WHILE MAINTAINING THE POSITION TO ATTEMPT TO MANUALLY EXPAND THE ANNULUS. THE VALVE WAS DEPLOYED AGAIN AND APPEARED TO OPEN MORE HOWEVER WAS STILL CONSTRICTED AND AN INFOLD WAS OBSERVED ON FLUOROSCOPY. THE VALVE WAS REMOVED FROM THE PATIENT. ANOTHER VALVE (J138595) WAS GOING TO BE PREPARED HOWEVER THE JAR WAS DIFFICULT TO OPEN. UPON OPENING THE JAR, PIECES OF THE JAR SEAL WERE OBSERVED FLOATING IN THE FLUID. THE VALVE WAS NOT USED. A DIFFERENT VALVE (J152168) WAS LOADED ON THE DCS AND THE VALVE CHECK SHOWED AN INFOLD TO THE 3RD NODE. A PRE-BAV WAS PERFORMED TWO TIMES WITH A 25 MM NON-MEDTRONIC VALVE. THE VALVE WAS DEPLOYED TOO SHALLOW AND WAS FULLY RECAPTURED. THE SECOND DEPLOYMENT THE VALVE WAS SUCCESSFULLY DEPLOYED AT 2 MM AND WAS FULLY IMPLANTED. NEW LEFT BUNDLE BRANCH BLOCK (LBBB) WAS OBSERVED. IT WAS REPORTED THAT PER THE PHYSICIAN, THE INFOLD AND VALVE CONSTRICTION WAS DUE TO A HEAVY CALCIFIED BICUSPID SIEVERS 0 AORTIC VALVE ANATOMY. THE PATIENT'S DIAMETER WAS 25.4 X 26.8 MM, THE PERIMETER WAS 82.3 MM, AND THE AREA WAS 516 MM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737445 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-29

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown