BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4110821 · Received September 23, 2014

    Report

    Report Number
    2953200-2014-01898
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    November 19, 2013
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. FOLLOW-UP OUTCOMES OF HYBRID PROCEDURES FOR THORACOABDOMINAL AORTIC PATHOLOGIES WITH SPECIAL FOCUS ON GRAFT PATENCY AND LATE MORTALITY. CLAUDIO BIANCHINI MASSONI, PHILIPP GEISBÜSCH, ENRICO GALLITTO, MAANI HAKIMI, MAURO GARGIULO, AND DITTMAR BÖCKLER. (J VASC SURG 2 014;59:1265-73.) ON UNKNOWN DATES BETWEEN JANUARY 2001 AND DECEMBER 2012, A VALIANT AND TALENT STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF ATHEROSCLEROTIC ANEURYSMS, DISSECTIONS, PENETRATING AORTIC ULCERS AND PSEUDOANEURYSMS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: OCCLUSION, STROKE, MI, RENAL FAILURE, ENDOLEAKS, DEATH, UNINTENTIONAL VESSEL COVERAGE, ISCHEMIA, TYPE A DISSECTION, PNEUMONIA. CARDIAC ISSUES, PULMONARY INSUFFICIENCIES/COMPLICATIONS, HERNIA OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO ANALYZE MIDTERM RESULTS OF BYPASS PATENCY AND OVERALL AND AORTIC-RELATED MORTALITY RATES OF HYBRID AORTIC PROCEDURES FOR THORACOABDOMINAL AORTIC PATHOLOGIES. METHODS: A RETROSPECTIVE STUDY WAS PERFORMED CONSIDERING PROSPECTIVELY COLLECTED DATA IN TWO CENTERS. FROM JANUARY 2001 TO DECEMBER 2012, 45 PATIENTS (33 MEN; MEAN AGE, 67.8 6 7.6 YEARS) RECEIVED HYBRID AORTIC PROCEDURES FOR THORACOABDOMINAL AORTIC DISEASES (31 ATHEROSCLEROTIC ANEURYSMS, 7 CHRONIC EXPANDING TYPE B AORTIC DISSECTIONS, 2 PENETRATING AORTIC ULCERS, AND 5 PSEUDOANEURYSMS), CORRESPONDING TO 155 REVASCULARIZED VISCERAL ABDOMINAL ARTERIES. ELECTIVE/ EMERGENCY AND STAGED/SIMULTANEOUS APPROACHES WERE 31 OF 14 AND 28 OF 17, RESPECTIVELY. PATIENT DEMOGRAPHICS, CLINICAL RISK FACTORS, AND AORTIC MORPHOLOGICAL AND PROCEDURAL DATA WERE COLLECTED. END POINTS WERE TECHNICAL SUCCESS, 30-DAY MORBIDITY, REINTERVENTION AND MORTALITY, BYPASS GRAFT PATENCY, FREEDOM FROM REINTERVENTION, AND OVERALL AND AORTIC RELATED MORTALITY DURING MIDTERM FOLLOW-UP. MEAN FOLLOW-UP WAS 2.2 6 2.4 YEARS. RESULTS: TECHNICAL SUCCESS WAS ACHIEVED IN 86.6% (39/45) OF PATIENTS. THIRTY-DAY MORBIDITY RATE WAS 60% (PARAPLEGIA/PARAPARESIS: 13.3%, STROKE: 6.7%, RENAL FAILURE: 31.3%, PERMANENT DIALYSIS: 4.4%). THIRTY-DAY FREEDOM FROM REINTERVENTION RATES WERE 67.1% AND 78.5%, RESPECTIVELY. THIRTY-DAY OCCLUSION OF REVASCULARIZED VISCERAL VESSELS OCCURRED IN 11 (7.1%, 11/155) TARGET ARTERIES. IN-HOSPITAL MORTALITY RATE WAS 24.4%. PRIMARY GRAFT PATENCY AFTER 1, 2, AND 4 YEARS WAS 89.7%, 85.3%, AND 79%, RESPECTIVELY. BYPASS THROMBOSIS OR STENOSIS DEVELOPED IN NINE (6.8%, 9/132) VESSELS DURING FOLLOW-UP. OF THESE, THREE PATIENTS REQUIRED REINTERVENTION AND ONE DIED. FREEDOM FROM REINTERVENTION RATES AFTER 1, 2, AND 4 YEARS WERE 45.6%, 45.6%, AND 34.2%, RESPECTIVELY. OVERALL AND AORTIC-RELATED MORTALITY RATES AFTER 1, 2, AND 4 YEARS WERE 32.6%, 41.4%, AND 45.3% AND 9.1%, 13.9%, AND 13.9%, RESPECTIVELY. CONCLUSIONS: A HYBRID PROCEDURE FOR THORACOABDOMINAL AORTIC PATHOLOGIES IN HIGH-RISK PATIENT IS FEASIBLE BUT CARRIES A SIGNIFICANT RATE OF EARLY AND MIDTERM REINTERVENTION AND DEATH. LONG-TERM SURVEILLANCE OF THE VISCERAL BYPASS IS NECESSARY BECAUSE ONE-THIRD OF THE PATIENTS WILL HAVE BYPASS-RELATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590455 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention