BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA STENT GRAFT

    MDR report key: 2153071 · Received June 29, 2011

    Report

    Report Number
    2953200-2011-01223
    Event Type
    Death
    Date Received
    June 29, 2011
    Date of Event
    March 22, 2011
    Report Date
    September 20, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: DEATH, LACK OF INFORMATION PROVIDED. EVALUATION, CONCLUSIONS: LACK OF INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 62 MM DIAMETER X 70 MM LONG THORACIC AORTA ANEURYSM APPROXIMATELY ONE YEAR AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS REPORTED AS THE PROXIMAL AORTIC NECK WAS 27 MM IN DIAMETER AND 20 MM LONG. THE AORTA WAS NON-TORTUOUS. ACCESS VESSELS HAD MILD CALCIFICATION AND MILD TORTUOSITY. IT WAS REPORTED THAT FOUR MONTHS POST STENT GRAFT IMPLANT, THE ANEURYSM SIZE HAS CHANGED TO 66.8 MM X 84.6 MM LONG AND NINE MONTHS POST INITIAL IMPLANTATION, THE ANEURYSM WAS 73 MM IN DIAMETER. IT WAS REPORTED THAT THERE WAS A RECOMMENDATION FOR INTERVENTION WITH THE IMPLANTATION OF A STENT GRAFT EXTENSION: HOWEVER, THE DETAILS OF WHAT THE INTERVENTION WAS TO TREAT WERE NOT REPORTED. IT WAS REPORTED THAT THE PT EXPIRED ON AN UNK DATE. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT WAS REMOTELY RELATED TO THE STUDY DEVICE AND TO THE STUDY PROCEDURE.

    Description of Event or Problem · 1

    THE INVESTIGATOR CALLED THE PATIENT TO RECOMMEND HAVING AN ADDITIONAL STENT GRAFT IMPLANTED. THE PATIENT WANTED TO THINK ABOUT THE INTERVENTION WHEN THE PHYSICIAN CALLED AGAIN, THE PATIENT'S FAMILY CONFIRMED THAT THE PATIENT EXPIRED. THE PATIENT MAY HAVE EXPIRED FROM AN AORTIC RUPTURE. ACCORDING TO THE INVESTIGATOR, NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT CAPTIVIA STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00434937

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death