BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3701615 · Received March 26, 2014

    Report

    Report Number
    2953200-2014-00589
    Event Type
    Death
    Date Received
    March 26, 2014
    Date of Event
    March 15, 2013
    Report Date
    March 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; PATHOLOGY-SPECIFIC SECONDARY AORTIC INTERVENTIONS AFTER THORACIC ENDOVASCULAR AORTIC REPAIR. SALVATORE T. SCALI, MD, ADAM W. BECK, MD, KHAYREE BUTLER, MD, ROBERT J. FEEZOR, MD, TOMAS D. MARTIN, MD, PHILIP J. HESS, MD, THOMAS S. HUBER, MD, PHD, AND CATHERINE K. CHANG, MD. (J VASC SURG 2014;59:599-607.) A TALENT AND VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF DESCENDING THORACIC ANEURYSM DISEASE. DURING THE RETROSPECTIVE STUDY, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA, TYPE IB, TYPE II, TYPE III (SEPARATION), TYPE IV ENDOLEAK, OPEN REPAIR, GRAFT COMPLICATIONS (IN FOLDING, INFECTION, RUPTURE), DISEASE PROGRESSION, TRANSVERSE ARCH REPLACEMENT, FISTULA, DEATH, NEUROLOGIC COMPLICATIONS, ISCHEMIA, STROKE, PULMONARY COMPLICATIONS, CARDIAC COMPLICATIONS, BLEEDING. OBJECTIVE: DESPITE IMPROVED SHORT-TERM OUTCOMES, CONCERNS REMAIN REGARDING DURABILITY OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). THE PURPOSE OF THIS ANALYSIS WAS TO EVALUATE THE PATHOLOGY-SPECIFIC INCIDENCE OF SECONDARY AORTIC INTERVENTIONS (SAI) AFTER TEVAR AND THEIR IMPACT ON SURVIVAL. METHODS: RETROSPECTIVE REVIEW WAS PERFORMED OF ALL TEVAR PROCEDURES AND SAI AT ONE INSTITUTION FROM 2004-2011. KAPLAN-MEIER ANALYSIS WAS USED TO ESTIMATE SURVIVAL. RESULTS: OF 585 PATIENTS, 72 (12%) REQUIRED SAI AT A MEDIAN OF 5.6 MONTHS (INTERQUARTILE RANGE, 1.4-14.2) WITH 22 (3.7%) REQUIRING MULTIPLE SAI. SAI INCIDENCE DIFFERED SIGNIFICANTLY BY PATHOLOGY (P [.002) [ACUTE DISSECTION (21.3%), POSTSURGICAL (20.0%), CHRONIC DISSECTION (16.7%), DEGENERATIVE ANEURYSM (10.8%), TRAUMATIC TRANSECTION (8.1%), PENETRATING ULCER (1.5%), AND OTHER ETIOLOGIES (14.8%)]. MOST COMMON INDICATIONS AFTER DISSECTION WERE PERSISTENT FALSE LUMEN FLOW AND PROXIMAL/DISTAL EXTENSION OF DISEASE. FOR DEGENERATIVE ANEURYSMS, SAI WAS PERFORMED PRIMARILY TO TREAT TYPE I/III ENDOLEAK. SAI PATIENTS HAD A GREATER MEAN NUMBER OF COMORBIDITIES (P <(><<)> .0005), STENTS PLACED (P [.0002), AND POSTOPERATIVE COMPLICATIONS AFTER THE INDEX TEVAR (P <(><<)> .0005) COMPARED WITH THOSE WITHOUT SAI. FREEDOM FROM SAI AT 1 AND 5 YEARS (95% CONFIDENCE INTERVAL) WAS ESTIMATED TO BE 86% (82%-90%) AND 68% (57%-76%), RESPECTIVELY. THERE WERE NO DIFFERENCES IN SURVIVAL (95% CONFIDENCE INTERVAL) BETWEEN PATIENTS REQUIRING SAI AND THOSE WHO DID NOT [SAI 1-YEAR, 88% (77%-93%); 5-YEAR, 51% (37%-63%); AND NO SAI 1-YEAR, 82% (79%-85%); 5-YEAR, 67% (62%-71%) (LOG-RANK, P[.2)]. CONCLUSIONS: SAI AFTER TEVAR IS NOT UNCOMMON, PARTICULARLY IN PATIENTS WITH DISSECTION, BUT DOES NOT AFFECT LONG-TERM SURVIVAL. AORTIC PATHOLOGY IS THE MOST IMPORTANT VARIABLE IMPACTING SURVIVAL AND DICTATED NEED, TIMING, AND MODE OF SAI. THE VARYING INCIDENCE OF SAI BY INDICATION UNDERSCORES THE NEED FOR DILIGENT SURVEILLANCE PROTOCOLS THAT SHOULD BE PATHOLOGY-SPECIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177367 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death| R