BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3238908 · Received July 22, 2013

    Report

    Report Number
    2953200-2013-01407
    Event Type
    Death
    Date Received
    July 22, 2013
    Date of Event
    September 14, 2012
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF DEATH IS UNKNOWN. THE EXACT DATE OF EVENT IS UNKNOWN. (B)(4). EVALUATION CODES, RESULTS: INHERENT RISK OF PROCEDURE (INFECTION, PARALYSIS, DISSECTION, FISTULA, ENDOLEAK, ANEURYSM ENLARGEMENT); (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN); UNAPPROVED USE OF DEVICE (IMPLANTING IN ZONE 0 AND 1). CONCLUSION: INHERENT RISK OF A PROCEDURE (INFECTION, PARALYSIS, DISSECTION, FISTULA, ENDOLEAK, ANEURYSM ENLARGEMENT); OFF ¿LABEL, UNAPPROVED OR CONTRAINDICATED USE (IMPLANTING IN ZONE 0 AND 1); (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    RESULTS OF HIGH-RISK ENDOVASCULAR PROCEDURES IN PATIENTS WITH NON-DISSECTED THORACIC AORTIC PATHOLOGY: INTERMEDIATE OUTCOMES. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 44 (2013) 156¿162 / DOI:10.1093/EJCTS/EZS694 THE FOLLOWING COMMERCIALLY AVAILABLE DEVICES WERE IMPLANTED: 91 TALENT/VALIANT OR VALIANT CAPTIVIA (MEDTRONIC VASCULAR, SANTA ROSA, CA, USA), 10 TAG/C¿TAG (W.L. GORE AND ASSOCIATES, FLAGSTAFF, AZ, USA) AND 4 RELAY NBS PLUS (BOLTON MEDICAL, INC., SUNRISE, FL, USA). STENT GRAFT SIZING WAS BASED ON PREOPERATIVE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IN ALL PATIENTS. OBJECTIVES TO INVESTIGATE MID-TERM OUTCOME IN PATIENTS UNDERGOING THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR NON-DISSECTED AORTIC PATHOLOGY WITH FAVOURABLE AND UNFAVOURABLE LANDING ZONE AND AORTIC ANATOMY. METHODS BETWEEN 2000 AND 2011, TEVAR WAS PERFORMED IN 208 PATIENTS WITH DESCENDING THORACIC AORTIC DISEASE. OF 105 PATIENTS WITH NON-DISSECTED THORACIC AORTIC PATHOLOGY, 69 PRESENTED WITH UNFAVOURABLE ANATOMY AS DEFINED BY SHORT LENGTH (<(><<)>15 MM), LARGE DIAMETER (>42 MM), ANGULATION OF >60° OF THE PROXIMAL OR DISTAL LANDING ZONE OR EXTREME AORTIC TORTUOSITY. THE ENDPOINTS PERIOPERATIVE MORTALITY, 1-YEAR SURVIVAL, ENDOLEAK OCCURRENCE AND INCIDENCE OF SECONDARY INTERVENTION WERE COMPARED WITH THE REMAINING 36 PATIENTS WITH FAVOURABLE ANATOMY. RESULTS MEDIAN FOLLOW-UP WAS 18 MONTHS. TEVAR WAS PERFORMED EMERGENTLY IN 24 OF 69 (35%) PATIENTS WITH UNFAVOURABLE ANATOMY AND IN 11 OF 36 (31%) OF THOSE WITH FAVOURABLE ANATOMY (P = 0.68). NO PATIENTS UNDERWENT CONVERSION TO OPEN SURGERY, NO PERI-INTERVENTIONAL RUPTURE WAS OBSERVED. PERIOPERATIVE MORTALITY DID NOT DIFFER BETWEEN COHORTS (1/69 VS 1/36, P = 0.78). POSTOPERATIVE PERMANENT SPINAL CORD ISCHEMIA OCCURRED IN PATIENTS WITH UNFAVOURABLE ANATOMY ONLY (2/69 VS 0/36, P = 0.78). EARLY ENDOLEAK AND SECONDARY INTERVENTION WERE MORE FREQUENT IN PATIENTS WITH UNFAVOURABLE ANATOMY (19/69 VS 7/36 AND 13/69 VS 1/36), BUT NOT STATISTICALLY SIGNIFICANT (P = 0.5 AND P = 0.13, RESPECTIVELY). ONE-YEAR AORTA-RELATED SURVIVAL RATES WERE SIMILAR IN BOTH GROUPS (66/69 VS 33/36, P = 0.45). CONCLUSIONS MID-TERM OUTCOME AFTER TEVAR DOES NOT DIFFER BETWEEN PATIENTS WITH FAVOURABLE AND UNFAVOURABLE LANDING ZONE ANATOMY IN TERMS OF AORTA-RELATED SURVIVAL. HOWEVER, THE MORE FREQUENT NEED FOR SECONDARY INTERVENTION WARRANTS A MORE RIGOROUS FOLLOW-UP AFTER TEVAR IN PATIENTS WITH UNFAVOURABLE ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339796 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death