BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 21157176 · Received January 15, 2025

    Report

    Report Number
    9612164-2025-00279
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    January 13, 2025
    Report Date
    June 5, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    DEVICE EVALUATION SUMMARY: THE SIDEPORT ASSEMBLY WAS DETACHED ON RECEIPT OF DEVICE AND DID NOT RETURN FOR ANALYSIS. THE GRAFT COVER PARTIALLY RETRACTED ON RECEIPT OF DEVICE WITH STENT GRAFT PARTIALLY EXPOSED, THE FREEFLO STRUTS WERE STILL CAPTURED ON THE TIP CAPTURE MECHANISM. A SLIGHT BEND WAS EVIDENT TO THE NOSECONE. DEFORMATION WAS EVIDENT TO THE SCREWGEAR THREADS. A CURVE WAS EVIDENT TO THE GRAFT COVER IN ORDER TO SUPPORT ROOT CAUSE DETERMINATION CROSS-FUNCTIONAL REVIEW WAS PERFORMED WITH R<(>&<)>D, PMQ AND MANUFACTURING SMES. THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED WITH HIGH DEPLOYMENT FORCE REQUIRED AND FRICTION NOTED BETWEEN STENT GRAFT AND GRAFT COVER. NO ISSUE WERE NOTED WITH THE EXTERNAL SLIDER. A LARGE AMOUNT OF FORCE WAS REQUIRED TO RELEASE THE FREE-FLO STRUTS FROM THE TIP CAPTURE MECHANISM. THE REAR HANDLE WAS OPENED AND A KINK WAS EVIDENT TO THE PROXIMAL PEEK TUBING. THE SILICONE SEAL HAD ADHERED TO THE PEEK TUBING. THE EXTERNAL SLIDER WAS OPENED AND INTERNAL SLIDER AND TRIGGER MECHANISM WERE REMOVED. NO DEFORMATION WAS EVIDENT TO THE TRIGGER MECHANISM OR SPRING. NO OTHER DEFORMATION EVIDENT TO THE REMAINDER OF THE DEVICE. THE REPORTED DEPLOYMENT DIFFICULTIES COULD BE CONFIRMED DURING ANALYSIS. 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

    CORRECTION TO H2, FILM EVALUATION SUMMARY: THE PREVIOUSLY REPORTED SENTENCE: "ALTHOUGH THE EVENT COULD NOT BE CONFIRMED, IT IS POSSIBLE THAT THE OBSERVED AORTIC ARCH ANGULATION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT" SHOULD READ: ALTHOUGH THE EVENT COULD NOT BE CONFIRMED, THE OBSERVED ARCH ANATOMY WOULD BE UNLIKELY TO HAVE CONTRIBUTED TO THE DEPLOYMENT ISSUES, ESPECIALLY CONSIDERING THE SUBSEQUENT SUCCESSFUL IMPLANTATION OF ANOTHER DEVICE. 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

    PRODUCT ANALYSIS CONCLUSION: THE REPORTED DEPLOYMENT DIFFICULTY COULD NOT BE FULLY CONFIRMED BASED ON THE LIMITED FILMS PROVIDED AS THE GRAFT COVER WAS ABLE TO BE SLOWLY PULLED BACK FOR THE ENTIRE 19-SECOND DURATION OF THE VIDEO. ALTHOUGH THE EVENT COULD NOT BE CONFIRMED, IT IS POSSIBLE THAT THE OBSERVED AORTIC ARCH ANGULATION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. FIVE (5) IMAGES OF THE VALIANT CAPTIVIA DEVICE WERE RECEIVED. DAMAGE WAS OBSERVED TO A NUMBER OF THE EXTERNAL SLIDER SCREW GEAR THREADS. THE GRAFT COVER WAS SEVERELY CURVED OVER THE END OF THE STENT STOP AND THE DISTAL SECTION OF THE STENT GRAFT. THE GRAFT COVER HAD BEEN RETRACTED TO EXPOSE THE FREEFLO PROXIMAL STENTS. THE REPORTED DEPLOYMENT/EXPANSION ISSUE WAS CONFIRMED BASED ON THE IMAGE REVIEW. B5; ADDITIONAL INFORMATION RECEIVED ; IT WAS REPORTED THAT THE DEVICE APPEARED NORMAL UPON INSPECTION PRIOR TO BEING USED. IT WAS CONFIRMED THAT THE DEVICE WAS DEPLOYED PER THE INSTRUCTIONS FOR USE (IFU). 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

    A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 439MM THORACIC AORTIC DISSECTION ON. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE STENT GRAFT WAS ACCURATELY POSITIONED AND READY TO BE DEPLOYED, HOWEVER THE PHYSICIAN ENCOUNTERED RESISTANCE IN THE HANDPIECE AND THE STENT GRAFT COULD NOT BE DEPLOYED. ANOTHER VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED SUCCESSFULLY INSTEAD. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO A MANUFACTURING PROCESS ISSUE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832210 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF3228C150TE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male