BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3727812 · Received April 4, 2014

    Report

    Report Number
    2953200-2014-00635
    Event Type
    Death
    Date Received
    April 4, 2014
    Date of Event
    May 5, 2011
    Report Date
    March 10, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: ENDOVASCULAR TREATMENT OF THORACIC AORTIC DISEASES. LAZAR DAVIDOVI, MIODRAG JEVTI, DJORDJE RADAK, DRAGAN SAGI, IVAN MARJANOVI, IGOR KONAR, MOMILO OLI, SINI¿A RUSOVI, ¿ELIMIR ANTONI. VOJNOSANIT PREGL 2013; 70(1): 32¿37. ACCEPTED ON (B)(6) 2011. THE PATIENTS DESCRIBED IN THIS ARTICLE HAD ENDOVASCULAR REPAIR FOR TREATMENT OF DEGENERATIVE THORACIC ANEURYSM, PENETRATING THORACIC AORTIC ULCER, TRAUMATIC THORACIC ANEURYSM, ANASTOMOTIC THORACIC ANEURYSM, RUPTURED THORACIC ANEURYSM, AND DISSECTED THORACIC ANEURYSM. PRIOR TO IMPLANT THERE WERE HYBRID PROCEDURES PERFORMED, A SUBCLAVIAN TRANSPOSITION, CAROTID-SUBCLAVIAN BYPASS, ILIAC CONDUIT, ABDOMINAL AORTIC RECONSTRUCTION, AORTIC ARCH DEBRANCHING, AND VISCERAL DEBRANCHING. THE FOLLOWING EVENTS WERE OBSERVED IN THIS JOURNAL ARTICLE; TYPE II ENDOLEAK, AORTOESOPHAGEAL FISTULA, REMOVAL OF IMPLANT, STROKE, COMA, INFECTION, AND DEATH. THERE IS NO FURTHER INFORMATION AVAILABLE. BACKGROUND/AIM. ENDOVASCULAR TREATMENT OF THORACIC AORTIC DISEASES IS AN ADEQUATE ALTERNATIVE TO OPEN SURGERY. THIS METHOD WAS FIRSTLY PERFORMED IN SERBIA IN 2004, WHILE ROUTINE USAGE STARTED IN 2007. AIM OF THIS STUDY WAS TO ANALYSE INITIAL EXPERIENCE IN ENDOVASCULAR TREATMENT OF THORACIC AORTIC DISEASES OF THREE MAIN VASCULAR HOSPITALS IN BELGRADE ¿ CLINIC FOR VASCULAR AND ENDOVASCULAR SURGERY OF THE CLINICAL CENTER OF SERBIA, CLINIC FOR VASCULAR SURGERY OF THE MILITARY MEDICAL ACADEMY, AND CLINIC FOR VASCULAR SURGERY OF THE INSTITUTE FOR CARDIOVASCULAR DISEASES ¿DEDINJE¿. METHODS BETWEEN (B)(6) 2004 AND (B)(6) 2010. PATIENTS WERE TREATED IN THESE THREE HOSPITALS DUE TO DIFFERENT DISEASES OF THE THORACIC AORTA. A TOTAL OF 21 PATIENTS HAD DEGENERATIVE ATHEROSCLEROTIC ANEURYSM, 6 PATIENTS HAD PENETRATING AORTIC ULCER, 6 HAD POSTTRAUMATIC ANEURYSM, 4 PATIENTS HAD RUPTURED THORACIC AORTIC ANEURYSM, 1 HAD FALSE ANASTOMOTIC ANEURYSM AFTER OPEN REPAIR, AND 3 PATIENTS HAD DISSECTED THORACIC ANEURYSM OF THE THORACOABDOMINAL AORTA. IN 15 CASES THE ENDOVASCULAR PROCEDURE WAS PERFORMED AS A PART OF THE HYBRID PROCEDURE, AFTER CAROTID SUBCLAVIAN BYPASS IN 4 PATIENTS AND SUBCLAVIAN ARTERY TRANSPOSITION IN 1 PATIENT DUE TO THE SHORT ANEURYSMATIC NECK; IN 2 PATIENTS ILIAC CONDUIT WAS USED DUE TO HYPOPLASTIC OR STENOTIC ILIAC ARTERY; IN 5 PATIENTS PREVIOUS RECONSTRUCTION OF ABDOMINAL AORTA WAS PERFORMED; IN 1 PATIENT COMPLETE DEBRANCHING OF THE AORTIC ARCH, AND IN 2 PATIENTS VISCERAL ABDOMINAL DEBRANCHING WERE PERFORMED. RESULTS. THE INTRAHOSPITAL MORTALITY RATE (30 DAYS) WAS 7.26% (3 PATIENTS WITH RUPTURED THORACIC ANEURYSMS DIED). ENDOLEAK TYPE II IN THE FIRST CONTROL EXAM WAS REVEALED IN 3 PATIENTS (7. 26%). THE PATIENTS WERE FOLLOWED UP IN A PERIOD OF 1¿72 MONTHS, ON AVERAGE 29 MONTHS. THE MOST DEVASTATING COMPLICATION DURING A FOLLOWUP PERIOD WAS AORTOESOPHAGEAL FISTULA IN 1 PATIENT A YEAR AFTER THE TREATMENT OF POSTTRAUMATIC ANEURYSM. CONVERSION WAS PERFORMED WITH EXPLANTATION OF STENT-GRAFT AND OPEN AORTIC IN SITU RECONTRUCTION, FOLLOWED BY ESOPHAGECTOMY AND THE CREATION OF CERVICAL AND GASTRICAL STOMA. CONCLUSION. HAVING IN MIND INITIAL RESULTS OF THE 3 MAIN VASCULAR CLINICS IN BELGRADE, SERBIA, ECONOMICAL SITUATION IN OUR COUNTRY, AS WELL AS THE PUBLISHED INTERNATIONAL RESULTS, ENDOVASCULAR TREATMENT OF THORACIC AORTIC DISEASES IS INDICATED IN HEMODYNAMICALLY UNSTABLE PATIENTS WITH ACUTE TRAUMATIC ANEURYSM, OR IN STABILE PATIENTS OLDER THAN 65, AS WELL AS IN CASE OF CHRONIC DISEASES OF THE THORACIC AORTA IN PATIENTS WITH SIGNIFICANT COMORBID CONDITIONS OR IN PATIENTS OLDER THAN 65 YEARS. ENDOVASCULAR PROCEDURES ON THE THORACIC AORTA COULD BE PERFORMED, HOWEVER, ONLY IN HIGH-VOLUME CENTERS WITH EXPERIENCE IN ROUTINE OPEN SURGERY OF THORACIC AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204512 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death