BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 6250824 · Received January 13, 2017

    Report

    Report Number
    2953200-2017-00048
    Event Type
    Death
    Date Received
    January 13, 2017
    Date of Event
    March 1, 2016
    Report Date
    January 3, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: VALIANT CAPTIVIA. FILM EVALUATION SUMMARY: FROM THE REVIEW OF SEVERAL SITE PHOTOGRAPHS DURING POST-MORTEM EXAMINATION, THE CAUSE OF THE ANEURYSM EXPANSION COULD NOT BE DETERMI NED. FILMS WERE NOT PROVIDED; THE IN-VIVO CONFIGURATION AND ENDOLEAK ASSESSMENT OF THE DEVICES DURING THE IMPLANT DURATION COULD NOT BE PERFORMED. IN ADDITION, ONLY A PARTIAL VIEW OF THE DEVICES WERE OBSERVED IN THE PHOTOGRAPHS, IMAGES OF THE CLEANED STENT GRAFT WERE NOT RETURNED, AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS, SO A COMPLETE ASSESSMENT OF THE EXPLANTED DEVICE COULD NOT BE PERFORMED. THE SIZE OF THE IMPLANTED DEVICES ARE ALSO UNKNOWN. TWO FABRIC HOLES WERE OBSERVED IN THE POST-MORTEM PHOTO¿S. A ~1.0 MM X 1.0 MM HOLE WAS SEEN LOCATED ~5 MM PROXIMAL TO THE SUPPORT STENT OF THE UNDERLYING DISTAL MAIN EXTENSION WHICH CAN BE SEEN IMPLANTED INSIDE THE PROXIMAL DEVICE. THERE WAS ALSO A POSSIBLE SMALLER TEAR (~0.5 MM X 1.0 MM) AT THE SAME LEVEL OF THE OTHER HOLE, LOCATED JUST BELOW THE ADJACENT DISTAL STENT APEX. BASED ON PREVIOUSLY OBSERVED RETURNED EXPLANTS, THESE 2 HOLES APPEARS MOST LIKELY TO BE STENT ABRASION OR CREASE FATIGUE RELATED. THE HOLES APPEAR TO BE LOCATED NEAR THE ARTICULATING COMPONENT JUNCTION, AND THEREFORE STENT GRAFT ANGULATION MAY HAVE CONTRIBUTED THE HOLES. ABRASION FROM OVERLAPPING COMPONENTS MAY HAVE ALSO BEEN A FACTOR. ALTHOUGH IT IS POSSIBLE THAT THE HOLES CONTRIBUTED TO THE TAA EXPANSION, IT IS UNKNOWN IF TISSUE/THROMBUS MAY HAVE BEEN COVERING THESE TWO HOLES IN-VIVO, AND IF THESE HOLES MAY HAVE BEEN THE SOURCE OF A TYPE III FABRIC ENDOLEAK IN-VIVO. IT WAS REPORTED THAT 3-YEARS POST-IMPLANT A DISTAL TYPE I ENDOLEAK WAS REPAIRED BY IMPLANTING A DISTAL EXTENSION, AND AT 6-YEARS DISTAL ANEURYSM EXPANSION WAS AGAIN REPORTED. THEREFORE, IT IS ALSO POSSIBLE THAT DISEASE PROGRESSION MAY HAVE BEEN THE CAUSE OF THE TAA EXPANSION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO PREVIOUS MDR: RETURN DATE: 2018-02-19. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FILM EVALUATION SUMMARY: CONCLUSIONS: THE EXACT CAUSE OF ANEURYSM EXPANSION COULD NOT BE DETERMINED FROM THE FILMS PROVIDED. PRE-IMPLANT CT¿S RETURNED REVEALED THAT THE PATIENT HAD A 64MM MAX DIAMETER TAA LOCATED JUST PAST THE AORTIC ARCH IN THE UPPER PORTION OF THE DESCENDING THORACIC. THE THORACIC HAD 2 ACUTELY ANGULATED BENDS; SEVERAL CM¿S CAUDAL TO THE LSA THE THORACIC WAS ANGULATED ~90DEG, AND JUST DISTAL TO THE TAA THE THORACIC WAS ANGULATED 90DEG PRIOR TO DESCENDING TO THE CELIAC ARTERY. THE INITIAL FOLLOW-UP CT RETURNED REVEALED THAT 2 VALIANT STENT GRAFTS HAD BEEN IMPLANTED. THE PROXIMAL CLOSED WEB DEVICE WAS POSITIONED JUST DISTAL TO THE LSA EXTENDING ACROSS THE ARCH, AND THE SECOND POSSIBLE CLOSED WEB DEVICE WAS OVERLAPPING THE PROXIMAL DEVICE ~8CM, AND EXTENDED TO WITHIN ~4CM OF THE CELIAC ARTERY. SEVERAL CM¿S DISTAL TO THE PROXIMAL MARGIN AS WELL AS NEAR THE DISTAL STENT GRAFT JUNCTION, THE STENT GRAFTS WERE ACUTELY ANGULATED ~90DEG ACROSS THE TORTUOUS BENDS. CT¿S RETURNED DURING SERIAL FOLLOW-UP¿S NOTED A CONTINUED INCREASE IN THE DIAMETER OF THE TAA, WITHIN BOTH THE PROXIMAL AND DISTAL SEGMENTS OF THE THORACIC. THE PROXIMAL TAA INCREASED FROM 64MM TO 82MM, AND THE DISTAL TAA INCREASED FROM 45MM TO 71MM IN DIAMETER. SEVERAL ENDOLEAKS WERE OBSERVED DURING FOLLOW-UP. AT THE 1 YEAR FOLLOW-UP A POSSIBLE TYPE II WAS SEEN COMING FROM NEAR THE TOP OF THE ARCH, AND THIS ENDOLEAK WAS SEEN AGAIN DURING SERIAL FOLLOW-UP¿S. BEGINNING AT 3 YEARS, CONTRAST WAS SEEN FROM A DISTAL TYPE IB ENDOLEAK. THIS ENDOLEAK WAS INITIALLY RESOLVED AFTER IMPLANTING AN ADDITIONAL DISTAL DEVICE, BUT WAS AGAIN OBSERVED AT THE 6 YEAR FOLLOW-UP. THE CAUSE OF THE TYPE IB WAS LIKELY DUE TO DISEASE PROGRESSION (THORACIC DILATATION) AND MORPHOLOGY CHANGES (INCREASING TORTUOSITY), AS THE THORACIC AORTA HAD EXPANDED TO ~63MM IN DIAMETER AT THE LEVEL OF THE DISTAL STENT GRAFT MARGIN WHICH APPEARED MORE ANGULATED. THE MOST RECENT RETURNED FILMS REVEALED A NEW AREA OF WIDESPREAD CONTRAST SEEN NEAR THE OVERLAPPING MID-LENGTH OF THE DEVICES, MOST LIKELY COMING FROM A TYPE III FABRIC ENDOLEAK, WHERE THE STENT GRAFTS WERE ANGULATED ~90DEG P-A. THE EXACT CAUSE OF THE TYPE IIIB ENDOLEAK IS UNKNOWN, AS THE EXPLANTED DEVICES WERE NOT RETURNED. HOWEVER, FROM THE FILMS AND OBSERVATION OF SEVERAL PHOTOGRAPHS OF THE EXPLANTED DEVICES WHICH NOTED 2 POTENTIAL FABRIC HOLES, THE SOURCE OF THE ENDOLEAK MAY HAVE BEEN CAUSED BY FABRIC ABRASION FROM THE OVERLAPPING COMPONENTS. THE HOLES IN THE PHOTO¿S WERE LIKELY LOCATED NEAR THE ARTICULATING COMPONENT JUNCTION. DISEASE PROGRESSION AND ANEURYSM MORPHOLOGY CHANGES APPEARED TO HAVE INCREASED THE AMOUNT OF STENT GRAFT ANGULATION DURING THE IMPLANT DURATION, AND IN CONJUNCTION WITH THE OVERLAPPING DEVICES, LIKELY CONTRIBUTED THE POTENTIAL FORMATION OF ABRASION HOLES LEADING TO THE TYPE III FABRIC ENDOLEAK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. AN ADDITIONAL VALIANT STENT GRAFT EXTENSION WAS IMPLANTED DISTALLY TO TREAT ANEURYSM EXPANSION AND A DISTAL TYPE I ENDOLEAK. IT WAS REPORTED THAT, APPROXIMATELY SIX YEARS AND THREE MONTHS POST INDEX PROCEDURE, IT WAS OBSERVED THAT THE ANEURYSM HAD EXPANDED IN THE DISTAL AREA AND THE PHYSICIAN ELECTED TO SCHEDULE AN INTERVENTION. HOWEVER, BEFORE AN INTERVENTION COULD BE PERFORMED, THE PATIENT PRESENTED EMERGENTLY AND EXPIRED WHILE UNDER ANESTHESIA. THE DEVICE WAS EXPLANTED POST MORTEM AND IT WAS DISCOVERED THAT THERE WAS A FABRIC HOLE IN THE VALIANT STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33343 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death