BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 9626893 · Received January 24, 2020

    Report

    Report Number
    9612164-2020-00398
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Date of Event
    January 20, 2020
    Report Date
    March 12, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION:IT WAS CONFIRMED THAT THE 200-LONG STENT'S PROXIMAL END WAS IN A TORTUOUS POSITION AT THE ARCH AND THE DISTAL END WAS JUST AT THE TWIST OF T11, AND THE STENT WAS STUCK BETWEEN THESE TWO TWISTED ANATOMICAL AREAS. AS A RESULT THE PHYSICIAN REPLACED THIS DEVICE WITH THE 3232150 STENT GRAFT, IT WAS FELT THAT THIS DEVICE'S SHEATH WAS THINNER AND MORE RESISTANT TO BENDING. THIS STENT WAS NOT AFFECTED WHEN BEING PASSED THROUGH THE TWO PREVIOUSLY NOTED TORTUOUS POSITIONS OF THE AORTA. IT WAS NOTED THAT THIS DEVICES DELIVERY SYSTEM WAS MORE FLEXIBLE AND WAS EASIER TO MANEUVER AROUND THE TWISTED T11 POSITION OF THE AORTA. ANALYSIS SUMMARY: TWO (2) PHOTOS OF THE DEVICE WERE RECEIVED. THE PHOTOS CAPTURE A KINK ON THE GRAFT COVER AT THE DISTAL END OF THE STENT STOP. BLOOD IS VISIBLE UNDER THE GRAFT COVER AT THE TIP. FILM REVIEW: THE REPORTED INABILITY TO ADVANCE THE STENT GRAFT TO THE INTENDED POSITION ACROSS THE THORACIC ARCH WAS CONFIRMED. FROM THE FILM RETURNED IT APPEARS LIKELY THAT THE HIGHLY TORTUOUS ANATOMY AND RESULTING LACK OF STENT GRAFT SUPPORT LED TO THE EVENTS. THE ARCH WAS ACUTELY ANGULATED ~90 DEG, AND THERE WAS TRUE LUMEN DIAMETER NARROWING OF THE DISSECTION AT THE MID-DESCENDING THORACIC WHICH WAS ALSO ANGULATED. IT IS ALSO POSSIBLE THAT THE IN-VITRO FENESTRATION MODIFICATION PERFORMED PRIOR TO IMPLANT MAY HAVE ALSO CONTRIBUTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT AS THE PATIENT HAS A HIGHLY ANGULATED AORTIC ARCH A FENESTRATION WAS MADE IN THE STENT GRAFT IN-VITRO TO MAINTAIN ACCESS TO THE LEFT SUBCLAVIAN ARTERY. IT WAS REPORTED THAT WHEN THE DELIVERY SYSTEM REACHED THE DESCENDING AORTIC ARCH THE DELIVERY SYSTEM WAS UNABLE TO BE TWISTED PAST THE AORTA AT THE T11 POSITION. A SNARE WAS USED TO ACCESS THE TIP OF THE SUPER-HARD GUIDEWIRE THROUGH THE RIGHT SUBCLAVIAN ARTERY, AND THROUGH STRETCHING OF THE GUIDEWIRE FURTHER SUPPORT WAS PROVIDED. HOWEVER, THE DELIVERY SYSTEM STILL COULD NOT PASS THE T11 POSITION AND THE TWISTED PART OF THE ARCH DESPITE REPEATED ATTEMPTS. IT WAS REPORTED THE DELIVERY SYSTEM BENT AT THE DISTAL END OF THE STENT DUE TO THE TWO TIPS OF THE 200MM LONG STENT BEING LOCATED BETWEEN THE BENT STENTS IN T11 AND THE ARCH, AND SO COULD NOT PASS THROUGH THE TWISTED PORTION OF THE ANATOMY. THE DEVICE WAS REPLACED WITH A 3232150 STENT GRAFT AND THE PROCEDURE SUCCESSFULLY COMPLETED - NO FENESTRATION WAS PERFORMED ON THIS GRAFT AND HALF OF THE LEFT SUBCLAVIAN WAS RETAINED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT¿S SEVERELY ANGULATED ARCH AND T11 POSITION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90116 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF3434C200TE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR