BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT

    MDR report key: 3680374 · Received March 14, 2014

    Report

    Report Number
    2953200-2014-00538
    Event Type
    Death
    Date Received
    March 14, 2014
    Date of Event
    June 7, 2012
    Report Date
    February 17, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSIONS: OFF-LABEL (PRE-OPERATIVE RUPTURE; PARARENAL AND THORACOABDOMINAL ANEURYSMS; CHIMNEY/PERISCOPE STENTING).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. CHIMNEY AND PERISCOPE GRAFTS OBSERVED OVER 2 YEARS AFTER THEIR USE TO REVASCULARIZE 169 RENOVISCERAL BRANCHES IN 77 PATIENTS WITH COMPLEX AORTIC ANEURYSMS. LACHAT M, VEITH FJ, PFAMMATTER T, GLENCK M, BETTEX D, MAYER D, RANCIC Z, GLOEKLER S, PECORARO F. (J ENDOVASC THER, 2013 OCT;20(5):597-605). DOI: 10.1583/13-4372.1 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE II ENDOLEAK, UNKNOWN ENDOLEAK, VESSEL OCCLUSION, RENAL FAILURE, DEATH, MULTIORGAN FAILURE, HEMATOMA, ILIAC RUPTURE, FISTULA, TYPE IA ENDOLEAK, TYPE IB ENDOLEAK, ANEURYSM ENLARGEMENT AND OCCLUSION OF THE BYPASS GRAFTS. NO FURTHER INFORMATION IS AVAILABLE FOR THESE EVENTS. PURPOSE: TO EVALUATE THE PERFORMANCE OF PERISCOPE AND/OR CHIMNEY GRAFTS (CPGS) IN THE ENDOVASCULAR TREATMENT OF PARARENAL OR THORACOABDOMINAL ANEURYSMS USING OFF-THE-SHELF DEVICES. METHODS: BETWEEN FEBRUARY 2002 AND AUGUST 2012, 77 CONSECUTIVE PATIENTS (62 MEN; MEAN AGE 73±9 YEARS) SUFFERING FROM PARARENAL AORTIC (N=55), THORACOABDOMINAL (N=16), OR ARCH TO VISCERAL ARTERY ANEURYSMS (N=6) WERE TREATED WITH AORTIC STENT-GRAFT IMPLANTATION REQUIRING CHIMNEY AND/OR PERISCOPE GRAFTS TO MAINTAIN SIDE BRANCH PERFUSION. CPGS WERE PLANNED IN ADVANCE AND WERE NOT USED AS BAILOUT. A STANDARDIZED FOLLOW-UP PROTOCOL INCLUDING COMPUTED TOMOGRAPHIC ANGIOGRAPHY, LABORATORY TESTING, AND CLINICAL EXAMINATION WAS PERFORMED AT 6 WEEKS; 3, 6, AND 12 MONTHS; AND ANNUALLY THEREAFTER. RESULTS: TECHNICAL SUCCESS WAS ACHIEVED IN 76 (99%) PATIENTS; 1 BRANCH STENT-GRAFT BECAME DISLOCATED FROM A RENAL ARTERY, WHICH COULD NOT BE RE-ACCESSED. OVERALL, 169 TARGET VESSELS (121 RENAL ARTERIES, 30 SUPERIOR MESENTERIC ARTERIES, 17 CELIAC TRUNKS, AND 1 INFERIOR MESENTERIC ARTERY) WERE ADDRESSED WITH THE CHIMNEY GRAFT CONFIGURATION IN 111 AND THE PERISCOPE GRAFT CONFIGURATION IN 58. IN TOTAL, 228 DEVICES WERE USED FOR THE CPGS: 213 VIABAHN STENT-GRAFTS AND 15 BARE METAL STENTS. OVER A MEAN 25±16 MONTHS (RANGE 1-121), 9 PATIENTS DIED OF UNRELATED CAUSES. NEARLY ALL (95%) OF THE PATIENTS DEMONSTRATED A DECREASED OR STABLE ANEURYSM SIZE ON IMAGING; THERE WAS A MEAN 13% SHRINKAGE IN ANEURYSM DIAMETER. TWENTY PATIENTS HAD PRIMARY TYPE I/III ENDOLEAKS AT DISCHARGE; IN FOLLOW-UP, ONLY 3 OF THESE WERE STILL PRESENT (NO SECONDARY OR RECURRENT ENDOLEAKS WERE NOTED). ADDITIONAL ENDOVASCULAR MANEUVERS WERE REQUIRED FOR CPG-RELATED COMPLICATIONS IN 13 PATIENTS FROM INTERVENTION THROUGHOUT FOLLOW-UP. OVERALL, 4 CPGS OCCLUDED (98% TARGET VESSEL PATENCY); NO STENT-GRAFT MIGRATION WAS OBSERVED. RENAL FUNCTION REMAINED STABLE IN ALL PATIENTS. CONCLUSION: IN THIS SERIES, THE USE OF CPGS HAS PROVEN TO BE A FEASIBLE, SAFE, AND EFFECTIVE WAY TO TREAT THORACOABDOMINAL AND PARARENAL ANEURYSMS WITH MAINTENANCE OF BLOOD FLOW TO THE RENOVISCERAL ARTERIES. NEARLY ALL OF THE ANEURYSMS SHOWED NO INCREASE IN DIAMETER OVER A >2-YEAR MEAN FOLLOW-UP, WHICH SUPPORTS THE MIDTERM ADEQUACY OF THE CPG TECHNIQUE AS A METHOD TO EFFECTIVELY REVASCULARIZE BRANCH VESSELS WITH FEW ENDOLEAKS OR BRANCH OCCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154410 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death| R