BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 4102148 · Received September 19, 2014

    Report

    Report Number
    2953200-2014-01869
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    December 18, 2013
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENT WAS OBSERVED: ANEURYSM RUPTURE, RETROGRADE TYPE A DISSECTION, TYPE I ENDOLEAK, PERSISTENT VISCERAL AND LOWER LIMB MALPERFUSION, FISTULA, TYPE B DISSECTION, OPEN SURGERY, RUPTURED ACCESS VESSELS, STROKE, PARAPLEGIA, TYPE II LEAK, THROMBOSIS OF THE FALSE LUMEN, RENAL FAILURE, MIGRATION, MODULAR DISCONNECTION, EMBOLI, OVER STENTING OF THE CELIAC ARTERY, DEVICE RELATED MULTIORGAN FAILURE, POST IMPLANTATION SYNDROME. BACKGROUND THE AIM OF THIS STUDY WAS TO DETERMINE MORBIDITY AND 30-DAY MORTALITY RATES OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR STANFORD B DISSECTION OVER A 16-YEAR PERIOD AND DETERMINE IF THESE RATES HAVE IMPROVED WITH BETTER STENT-GRAFT TECHNOLOGY AND SURGICAL TECHNIQUE. METHODS ELECTRONIC DATABASES WERE SEARCHED IN ALL LANGUAGES AND A SYSTEMATIC REVIEW CONDUCTED. A COMPARISON OF THE EARLY (1998¿2007 ¼ 787 PATIENTS) AND LATER (2007¿2013 ¼ 787 PATIENTS) HALVES OF THE PATIENT POPULATION WAS DONE. STUDIES WERE CHOSEN BASED ON AVAILABILITY OF DETAILS REGARDING MORBIDITY AND MORTALITY. AMBIGUOUS STUDIES WERE EXCLUDED. RESULTS A TOTAL OF 69 SUITABLE STUDIES PUBLISHED BETWEEN 1998 AND 2013 (1,574 PATIENTS) WERE EXAMINED INCLUDING 1 RANDOMIZED CONTROL TRIAL, 55 RETROSPECTIVE STUDIES, 3 PROSPECTIVE, 1 MIXED, AND 9 CASE REPORTS. OVERALL MORTALITY AND MORBIDITY RATES FOR TEVAR WAS 8.07% (N ¼ 127) AND 30.8% (N ¼ 485), RESPECTIVELY. THE STENT-GRAFT¿RELATED DEATH RATE WAS 6.20% (97 CASES EXCLUDING MEDICALLY RELATED DEATHS). THE ENDOLEAK RATE WAS 5.9% OF WHICH MOST WERE TYPE I. MAJOR COMPLICATIONS INCLUDE STROKE (2.7%), PARAPLEGIA (1.9%), PARTIAL THROMBOSIS OF FALSE LUMEN (2.5%), RETROGRADE TYPE A DISSECTION (3.1%), VISCERAL MALPERFUSION (2.0%), CONVERSION TO OPEN INTERVENTION (1.9%), AND SECONDARY INTERVENTION (4.1%). THE STENT-GRAFT¿RELATED MORTALITY RATE INCREASED IN THE 2007 TO 2013 GROUP COMPARED WITH THE 1998 TO 2007 GROUP (56.2 VS. 24% OF PATIENTS WHO DIED; P <(><<)> 0.05). THERE WAS ALSO AN INCREASE IN THE OVERALL MORBIDITY RATES FROM 25% (1998¿2007) TO 36.6% (2007¿2013) BUT DID NOT REACH STATISTICAL SIGNIFICANCE P > 0.05. CONCLUSION MORTALITY AND MORBIDITY RATES FOR TEVAR SEEMED TO HAVE INCREASED OVER THE PAST 16 YEARS DESPITE IMPROVED TECHNOLOGY AND SURGICAL TECHNIQUE. THIS MAY BE EXPLAINED BY THE INCREASING LIBERAL USE OF TEVAR INTERVENTION AND QUITE POSSIBLY BETTER REPORTING. THE CURRENT DATA ARE HIGHLY HETEROGENOUS MAKING IT DIFFICULT FOR SOLID CONCLUSIONS TO BE DRAWN. THE ONLY WAY FORWARD IS THROUGH BETTER DATA REGISTRIES AND WELL-DESIGNED CLINICAL TRIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583624 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention