BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX - UNK

    MDR report key: 5654175 · Received May 13, 2016

    Report

    Report Number
    2953200-2016-01021
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    January 1, 2003
    Report Date
    May 3, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATES OF THE EVENTS ARE UNKNOWN. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; MORPHOLOGICAL AND FUNCTIONAL MODIFICATIONS OF THE ANEURYSM-ENDOGRAFT COMPLEX FOLLOWING ENDOLUMINAL EXCLUSION IN 30 CONSECUTIVE CASES MAURO FREGO, GIORGIO BIANCHERA, DIMITRIOS KONTOTHANASSIS, FABIO PILON, GIOVANNI AMBROSINO, LORETTA DI CRISTOFARO, ELISA BONELLO, DIEGO MIOTTO, CLAUDIO FITT, GIUSEPPE TROPEANO, GIULIO BARBIERO (ACTA BIO MEDICA 2003; 74; SUPPL. 2: 45-50) TALENT AAA AND ANEURX STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: MYOCARDIAL INFARCTION, ANEURYSM RUPTURE, TYPE III FABRIC ENDOLEAK, EPIGASTRIC PAIN, OCCLUSION, PARIETAL THROMBOSIS OF THE STENT GRAFT, MIGRATION, PROXIMAL TYPE I ENDOLEAK THAT SELF-RESOLVED, TYPE II ENDOLEAK. ABSTRACT. DATA FROM 30 CONSECUTIVE EXCLUDED ABDOMINAL AORTIC ANEURYSMS (AAA) HAVE BEEN ANALYSED, TO VERIFY WHETHER IMPORTANT MORPHOLOGICAL CHANGES TAKE PLACE AFTER EXCLUSION, AND WHETHER THESE CAN BE CONSIDERED AS RISK FACTORS FOR FUNCTIONAL (LEAKS, FLOW ALTERATIONS) AND CLINICAL COMPLICATIONS (RUPTURE, OBSTRUCTION). ALL AAAS HAVE BEEN INITIALLY SUCCESSFULLY EXCLUDED AND PATIENTS HAVE BEEN FOLLOWED UP BY CLINICAL EXAMINATIONS AND CT SCAN CONTROLS POST-OPERATIVELY, AT THE THIRD AND SIXTH MONTH, THEN YEARLY. AT A MEAN FOLLOW-UP OF 17 MONTHS, DIMENSION OF THE PROXIMAL NECK INCREASED SIGNIFICANTLY (>2 MM IN DIAMETER) IN FIVE PTS AND GRAFT WAS DISTALLY DISLODGED IN TWO. MAXIMUM ANEURYSM DIAMETER REDUCED SIGNIFICANTLY (AT EAST 10% THAN ORIGINALLY) IN HALF OF THE CASES AND MORE THAN 25% IN 10% OF CASES. FOUR AAAS PRESENTED AN INITIAL INCREASE, THAT REDUCED ONLY IN TWO. CALCULATION OF STRENGTH OF THE AAA WAS UNRELIABLE DUE TO TORTUOSITY. TWO SECONDARY TYPE II LEAKS AND ONE SECONDARY TYPE III LEAK WERE OBSERVED ASSOCIATED TO STABLE OR SLIGHTLY INCREASED AAA DIAMETER (THE LATTER PATIENT SUDDENLY DIED PROBABLY FOR MYOCARDIAL INFARCTION, BUT A RUPTURE COULD NOT BE FORMALLY EXCLUDED). MARKED TORTUOSITY OF THE GRAFT WAS SEEN IN FIVE PATIENTS, ALL ASSOCIATED WITH FRANK SHRINKAGE OF THE ANEURYSMAL SAC. PARIETAL THROMBOSIS WITHOUT EXPLANATION WAS OBSERVED IN FIVE, AND IN ONE PROGRESSED TO OBSTRUCTION OF AN ILIAC BRANCH. TWO PTS NEEDED ANTICOAGULATION. THESE DATA INDICATE THAT ENDOLUMINAL ANEURYSM EXCLUSION CAN NOT BE CONSIDERED AS A DEFINITIVE SOLUTION, FOR LONG-TERM OUTCOME IS UNFORESEEABLE IN A NUMBER OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308753 ANEURX - UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention