BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 6038960 · Received October 19, 2016

    Report

    Report Number
    2953200-2016-01816
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    September 23, 2016
    Report Date
    January 12, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) UNAPPROVED OR CONTRAINDICATED USE (AORTIC DIAMETER LESS THAN 20 MM). 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

    FILM EVALUATION SUMMARY: THE EXACT CAUSE OF INACCURATE DELIVERY AND REMOVAL DIFFICULTY, LEADING TO VESSEL PERFORATION, WHICH RESULTED IN THE PATIENT DEATH COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PRE-IMPLANT CTA'S PROVIDED. THE FILMS AT IMPLANT WERE NOT PROVIDED. IT IS POSSIBLE THAT IMPLANTING THE 42 MM DIAMETER VALIANT STENT GRAFT IN A SMALL TRUE LUMEN (OVERSIZING) MAY HAVE CONTRIBUTED TO THE EVENTS. THE PRE-IMPLANT CTA'S SHOWED THAT THE TRUE LUMEN DIAMETER JUST CAUDAL TO THE LSA MEASURED ~12 MM, AT 4 CM DISTALLY WAS ~10 MM, AND AT 8 CM DISTALLY WAS ~ 12 MM. 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

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE REPORTED REMOVAL DIFFICULTY LEADING TO THE STENT GRAFT BEING PULLED DOWN, WHICH RESULTED IN THE INACCURATE PLACEMENT OF THE STENT GRAFT, PERFORATION OF THE AORTA AND PATIENT DEATH CANNOT BE CONFIRMED AS EVENTS OCCURRED IN-VIVO. THE EXACT CAUSE OF EVENTS CANNOT BE CONCLUSIVELY DETERMINED. INSPECTION OF THE RETURNED DEVICE DID NOT REVEAL ANY OBVIOUS DEVICE ISSUE. IT IS POSSIBLE THAT IMPLANTING THE STENT GRAFT IN A SMALL TRUE LUMEN (10-14 MM IN DIAMETER AS STATED BY THE REPORTED INFORMATION) MAY HAVE CONTRIBUTED TO THE EVENTS. 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.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE B THORACIC DISSECTION. THE VALIANT STENT GRAFT WAS OVERSIZED. DURING THE INDEX PROCEDURE, THE VALIANT STENT GRAFT WAS DEPLOYED WITH THE DISTAL END OF THE STENT GRAFT LANDED IN A VERY SMALL IN DIAMETER TRUE LUMEN (10-14 MM) WHICH WAS CLOSE TO BEING COLLAPSED. THE PHYSICIAN HAD DIFFICULTIES REMOVING THE DELIVERY SYSTEM PULLING DOWN THE VALIANT STENT GRAFT RESULTING IN THE INACCURATE PLACEMENT AND PERFORATION OF THE AORTA, DUE TO THE SMALL TRUE LUMEN. THE PHYSICIAN INSERTED A SECOND VALIANT STENT GRAFT TO EXTEND THE FIRST VALIANT STENT GRAFT PROXIMALLY. IT WAS REPORTED THAT DURING THE INSERTION OF THE SECOND VALIANT STENT GRAFT THE PATIENT EXPIRED. PER THE PHYSICIAN, THE CAUSE OF THE PATIENT'S DEATH WAS NOT RELATED TO THE DEVICE BUT WAS DUE TO RUPTURING/PERFORATION OF THE AORTA. NO ADDITIONAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692228 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF4242C200TE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death