BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2823334 · Received November 7, 2012

    Report

    Report Number
    2953200-2012-02154
    Event Type
    Death
    Date Received
    November 7, 2012
    Report Date
    October 12, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (RUPTURE, INFECTION), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-STENT GRAFT IMPLANTATION INFECTION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-STENT GRAFT IMPLANTATION INFECTION).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: ENDOVASCULAR TREATMENT OF INFECTED AORTIC ANEURYSMS, EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY 44 (2012) 385-394. OBJECTIVE: TO REPORT ON THE SHORT- AND LONG-TERM OUTCOMES OF PATIENTS WITH PRIMARY INFECTED AORTIC ANEURYSM (IAA) TREATED BY STENT GRAFT (SG) IN TWO CENTERS. MATERIAL AND METHOD: OVER A PERIOD OF 15 YEARS, (B)(4) PATIENTS WITH IAA UNDERWENT ENDOVASCULAR TREATMENT. NONE HAD UNDERGONE PREVIOUS AORTIC SURGERY. THE CAUSAL RELATIONSHIP WAS GASTROINTESTINAL INFECTION IN (B)(4) PATIENTS (B)(4), ENDOVASCULAR DIAGNOSTIC/THERAPEUTIC PROCEDURES/RESUSCITATION IN (B)(4), WOUND INFECTION AFTER PREVIOUS SURGERIES IN (B)(4), URINARY INFECTION IN (B)(4), UROLOGY OR GASTROENTEROLOGY PROCEDURES IN (B)(4), PANCREATITIS IN (B)(4), ENDOCARDITIS IN (B)(4),AND PHLEBITIS IN (B)(4) PATIENT. WE IMPLANTED 11 BIFURCATED, 10 TUBULAR THORACIC, 4 AORTO-UNI-ILIAC, 4 TUBULAR ABDOMINAL AND 1 ILIAC SG. TWO OTHER SURGERIES WERE HYBRID PROCEDURES. RESULTS: THE ETIOLOGICAL AGENT WAS IDENTIFIED IN (B)(4) PATIENTS. (B)(4) PATIENTS SURVIVED THE 30-DAY POSTOPERATIVE PERIOD. (B)(4) SURVIVED TO 1-YEAR FOLLOW-UP AND (B)(4) SURVIVED TO 3-YEAR FOLLOW-UP. THREE PATIENTS HAVE SURVIVED FOR LESS THAN 1 YEAR AND A FURTHER 3 FOR LESS THAN 3 YEARS, SO FAR. AMONG PATIENTS WITH ANEURYSMS SITUATED IN CENTRAL PARTS OF THE THORACIC AND INFRARENAL AORTA THERE WAS A BETTER DEATH/SURVIVAL RATIO THAN AMONG PATIENTS WITH A PROXIMAL OR DISTAL ANEURYSM LOCATION. CONCLUSION: THE IMPLANTATION OF A SG MAY BE AN ALTERNATIVE TO OPEN SURGERY IN SELECTED GROUPS OF PATIENTS WITH PRIMARY IAA. ANEURYSMS OF THE CENTRAL PART.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention