BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 4783087 · Received May 19, 2015

    Report

    Report Number
    2953200-2015-00916
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    July 23, 2010
    Report Date
    April 29, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THIS JOURNAL ARTICLE: RISK FACTORS FOR LATE MORTALITY AFTER ENDOVASCULAR REPAIR OF THE THORACIC AORTA. JAYER CHUNG, MD, MATTHEW A. CORRIERE, MD, MS, RAVI K. VEERASWAMY, MD, KARTHIKESHWAR KASIRAJAN, MD, ROSS MILNER, MD, THOMAS F. DODSON, MD, ATEF A. SALAM, MD, AND ELLIOT L. CHAIKOF, MD, PHD, ATLANTA, GA (J VASC SURG. 2010 SEP;52(3):549-54; EPUB 2010 JUL 23) A TALENT TAA STENT GRAFT WAS IMPLANTED IN PATIENTS THAT WERE TREATED FOR DEGENERATIVE ANEURYSM, AORTIC DISSECTION, PENETRATING AORTIC ULCER OR INTRAMURAL HEMATOMA, MYCOTIC ANEURYSM, TRAUMATIC PSEUDOANEURYSM OR TRANSECTION, ANASTOMOTIC PSEUDOANEURYSM, OR OTHER PATHOLOGY, SUCH AS KOMMERELL DIVERTICULUM, ¿FLOATING¿ INTRA-AORTIC THROMBI, OR RESTENOSIS OF A PRIOR AORTIC COARCTATION REPAIR. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: CARDIAC, STROKE/SPINAL CORD ISCHEMIA, PULMONARY, RENAL FAILURE, MALIGNANCY, MESENTERIC ISCHEMIA, FAILED EXCLUSION OF THORACIC AORTIC RUPTURE, INFRARENAL ANEURYSM RUPTURE, AND DEATH. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVE: THIS STUDY WAS CONDUCTED TO IDENTIFY RISK FACTORS FOR LATE MORTALITY AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). METHODS: A RETROSPECTIVE ANALYSIS OF CONSECUTIVE TEVAR WAS CONDUCTED. MEDICAL RECORD REVIEW, TELEPHONE CONTACT, OR QUERY OF THE SOCIAL SECURITY DEATH INDEX WAS USED TO DETERMINE 30-DAY AND LATE SURVIVAL. LATE MORTALITY WAS ASSESSED WITH RESPECT TO PATIENT CHARACTERISTICS AT THE TIME OF THE INITIAL TREATMENT, PREOPERATIVE LABORATORY VALUES, PATHOLOGY, CLINICAL PRESENTATION, AND TREATMENT ADJUNCTS. SIGNIFICANT UNIVARIATE PREDICTORS OF DEATH WERE ENTERED INTO A MULTIVARIATE COX PROPORTIONAL HAZARDS MODEL. RESULTS: FROM 1998 TO 2009, 252 PATIENTS (149 MEN; MEAN AGE, 68 YEARS) UNDERWENT TEVAR FOR DEGENERATIVE THORACIC AORTIC ANEURYSM (TAA, N _ 143), TYPE B DISSECTION (N _ 62), MYCOTIC ANEURYSM (N _ 13), TRAUMATIC DISRUPTION (N _ 12), PENETRATING ULCER OR INTRAMURAL HEMATOMA (N _ 10), ANASTOMOTIC PSEUDOANEURYSM (N _ 4), OR OTHER PATHOLOGY (N _ 8). THE 30-DAY MORTALITY WAS 9.5%, WITH STROKE OR SPINAL CORD INJURY IN 5.6%. MEAN FOLLOW-UP WAS 22 _ 22 MONTHS. KAPLAN-MEIER MEAN SURVIVAL WAS 53 MONTHS. PREDICTORS OF LATE MORTALITY BY UNIVARIATE ANALYSIS INCLUDED AGE (P <(><<)> .01), CARDIAC ARRHYTHMIA (P _ .03), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (P _ .05), ANEURYSM DIAMETER (P <(><<)> .01), RUPTURE (P <(><<)> .01), DEBRANCHING (P _ .02), LEUKOCYTOSIS (WHITE BLOOD CELL COUNT > 10.0 _ 103/_L; P <(><<)> .01), ALBUMIN, (P <(><<)> .01), AND CREATININE > 1.7 MG/DL (P _ .01). MULTIVARIATE PREDICTORS OF MORTALITY INCLUDED RUPTURE (HAZARD RATIO [HR], 3.10; 95% CONFIDENCE INTERVAL [CI], 1.02-9.44; P _ .03), DEBRANCHING (HR, 2.20; 95% CI, 1.09-4.24; P _ .03), PREOPERATIVE LEUKOCYTOSIS (HR, 1.23; 95% CI, 1.09-1.39; P _ .001), AND ANEURYSM DIAMETER (HR, 1.02; 95% CI, 1.01-1.03; P _ .04). SUBGROUP ANALYSIS OF PATIENTS UNDERGOING TEVAR FOR ASYMPTOMATIC, NONRUPTURED TAA DEMONSTRATED THAT DEBRANCHING (HR, 2.47; 95% CI, 1.13-5.39; P _ .02), WHITE BLOOD CELL COUNT (HR, 1.19; 95% CI, 1.01-1.40; P <(><<)> .04), AND ANEURYSM DIAMETER (HR, 1.03; 95% CI, 1.01-1.05, P <(><<)> .01) REMAIN INDEPENDENTLY PREDICTIVE OF LATE MORTALITY. CONCLUSIONS: PREOPERATIVE LEUKOCYTOSIS, ANEURYSM DIAMETER, AND CONCURRENT DEBRANCHING INDEPENDENTLY PREDICT LATE MORTALITY IRRESPECTIVE OF CLINICAL PRESENTATION AND MAY ASSIST IN RISK STRATIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326399 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention