BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT THORACIC STENT GRAFT SYSTEM

    MDR report key: 3013561 · Received March 20, 2013

    Report

    Report Number
    2953200-2013-00494
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    April 21, 2008
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS AND CONCLUSIONS: INHERENT RISK OF PROCEDURE (ANEURYSM EXPANSION); LACK OF INFORMATION (UNKNOWN CAUSE OF ANEURYSM ENLARGEMENT).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 39 MM DIAMETER THORACIC AORTIC ANEURYSM IN ZONE 3 APPROXIMATELY 66 MONTHS AGO. THE PROXIMAL AORTA WAS 30 MM IN DIAMETER. DISTAL AORTA WAS 28 MM IN DIAMETER. RIGHT ILIAC ARTERY WAS 6 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 8 MM IN DIAMETER. THE RIGHT FEMORAL ARTERY WAS 8 MM IN DIAMETER. IT WAS REPORTED THAT TWO DAYS POST IMPLANT A VALIANT (B)(4) WAS IMPLANTED IN ZONE 3. A CT WITH CONTRAST ONE MONTH POST IMPLANT SHOWED MAXIMUM ANEURYSM DIAMETER AS 38.3 MM. NO ENDOLEAKS WERE NOTED. FIVE MONTHS AFTER THAT A CT WITH CONTRAST SHOWED MAXIMUM ANEURYSM DIAMETER AS 53 MM. NO ENDOLEAKS NOTED. NO INTERVENTION WAS PERFORMED. EVENT IS CONTINUING. THE INVESTIGATOR ASSESSED THIS EVENT AS NOT PROCEDURE RELATED AND UNKNOWN IF DEVICE RELATED. FIVE MONTHS AFTER THAT A CT WITH CONTRAST SHOWED MAXIMUM ANEURYSM DIAMETER AS 41 MM. NO ENDOLEAKS NOTED. TWO YEARS POST IMPLANT A CT WITH CONTRAST SHOWED MAXIMUM ANEURYSM DIAMETER AS 42 MM. NO ENDOLEAKS NOTED. THREE YEARS POST IMPLANT A CT WITH CONTRAST SHOWED MAXIMUM ANEURYSM DIAMETER AS 38 MM. NO ENDOLEAKS NOTED. FOUR YEARS POST IMPLANT A CT WITH CONTRAST SHOWED MAXIMUM ANEURYSM DIAMETER AS 42 MM. NO ENDOLEAKS NOTED. FIVE YEARS POST IMPLANT A CT WITH CONTRAST SHOWED MAXIMUM ANEURYSM DIAMETER AS 46 MM. NO ENDOLEAKS NOTED. PLEASE NOTE THAT THIS MODEL NUMBER TF3636C200XC IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE VAMC3636C200TE WHICH IS APPROVED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116278 VALIANT THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00004458

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR