BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 2309699 · Received October 26, 2011

    Report

    Report Number
    2953200-2011-01861
    Event Type
    Injury
    Date Received
    October 26, 2011
    Report Date
    September 27, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INFORMATION DOES NOT MATCH INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC. CONTINUED FROM BLOCK. EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, OCCLUSION).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE, WHICH IS SUMMARIZED AS FOLLOWS: IMPACT OF STENT-GRAFT DEVELOPMENT ON OUTCOME OF ENDOVASCULAR REPAIR OF ACTUE TRAUMATIC TRANSECTION OF THE THORACIC AORTA. J ENDOVASC THER 2011; 18:485-490. TALENT AND VALIANT THORACIC STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ACUTE TRAUMATIC AORTIC RUPTURES. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. RESULTS WITH FIRST AND SECOND GENERATION STENT GRAFTS FOR REPAIR OF ACUTE TRAUMATIC THORACIC AORTIC TRANSECTION ARE COMPARED. FROM (B)(6) 2001 TO (B)(6) 2007, 32 PATIENTS WERE TREATED WITH THE FIRST GENERATION OF COMMERCIALLY AVAILABLE THORACIC STENT-GRAFTS (TALENT, AND TWO OTHER MANUFACTURERS). FROM (B)(6) 2007 TO (B)(6) 2011, 16 PATIENTS WERE TREATED WITH SECOND-GENERATION THORACIC STENT-GRAFTS (VALIANT, AND ONE OTHER MANUFACTURER). THE TWO GROUPS WERE STATISTICALLY COMPARABLE. THERE WAS NO MORTALITY RATE RELATED TO AORTIC REPAIR. THE MORBIDITY RATE WAS SIGNIFICANTLY REDUCED (P=0.0003) FROM 18.7% (FIRST GENERATION) TO 6.2% (SECOND GENERATION). TYPE I ENDOLEAK, INADVERTENT COVERAGE OF THE SUPRA-AORTIC TRUNKS, AND STENT-GRAFT COLLAPSE OCCURRED ONLY WITH THE FIRST-GENERATION STENT-GRAFTS. ONE ILIAC ARTERY RUPTURE OCCURRED WITH A SECOND-GENERATION STENT-GRAFT. ENHANCED STENT-GRAFT CONFORMABILITY AND MORE ACCURATE DELIVERY SYSTEMS HAVE SIGNIFICANTLY DECREASED THE MORBIDITY OF ENDOVASCULAR REPAIR OF ACUTE TRAUMATIC TRANSECTION OF THE THORACIC AORTA. THE INCREASING CLINICAL EXPERIENCE MAY ALSO HAVE CONTRIBUTED TO IMPROVED RESULTS. THE PATIENTS ARE FINE. ((B)(6)).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention