BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3483472 · Received November 22, 2013

    Report

    Report Number
    2953200-2013-02286
    Event Type
    Injury
    Date Received
    November 22, 2013
    Date of Event
    September 12, 2012
    Report Date
    October 29, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). (UNKNOWN CAUSE OF EVENT). EVALUATION CONCLUSION: (UNKNOWN CAUSE OF EVENT). KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK).

    Description of Event or Problem · 1

    THE DOUBLE TWO-CHIMNEY TECHNIQUE FOR COMPLETE RENOVISCERAL REVASCULARIZATION IN A SUPRARENAL ANEURYSM. JIP L. TOLENAAR. J VASC SURG 2013;58:478-81. PURPOSE: AORTIC ANEURYSMS WITH AORTIC SIDE BRANCH INVOLVEMENT REQUIRE EXTENSIVE OPEN SURGICAL REPAIR AND ARE ASSOCIATED WITH HIGH MORBIDITY AND MORTALITY RATES COMPARED WITH STANDARD OPEN SURGICAL REPAIR. BRANCHED AND FENESTRATED STENT GRAFTS OFFER AN ATTRACTIVE TREATMENT OPTION IN HIGH RISK PATIENTS BUT ARE NOT YET GENERAL APPLICABLE IN THE ACUTE SETTING. MOREOVER, SEVERAL PATIENTS HAVE AN UNFAVORABLE ANATOMY FOR THESE TYPES OF STENT GRAFTS AND ARE CONSIDERED UNSUITABLE. AT 3-5 TO OBVIATE THIS PROBLEM, ALTERNATIVE INTERVENTIONS LIKE THE DOUBLE-BARREL TECHNIQUE, SANDWICH TECHNIQUE, AND THE CHIMNEY PROCEDURE HAVE BEEN DEVELOPED. METHOD: A CHIMNEY PROCEDURE WITH PRESERVATION OF THE CELIAC TRUNK, SMA, AND BOTH RENAL ARTERIES WAS PLANNED. DURING PREOPERATIVE PLANNING, THE AREA OF THE AORTIC LUMEN THAT WOULD BE COMPROMISED BY THE GRAFTS WAS CALCULATED TO ENSURE DISTAL CIRCULATION. STENT GRAFTS ARE ROUTINELY OVERSIZED BETWEEN 20 PERCENT AND 30 PERCENT. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA, AND OPEN EXPOSURE OF THE FEMORAL ARTERIES AND LEFT BRACHIAL ARTERY WAS OBTAINED. THROUGH THE LEFT BRACHIAL ARTERY, A 10F SHEATH WAS ADVANCED BY, AND THE SMA AND CELIAC TRUNK WERE ACCESSED. A SELF-EXPANDABLE STENT GRAFT WAS DEPLOYED IN THE CELIAC TRUNK AND SUBSEQUENTLY, A SELF-EXPANDABLE STENT GRAFT IN THE SMA. AFTER BOTH CHIMNEY GRAFTS WERE DEPLOYED, THEY WERE EXTENDED PROXIMALLY WITH BALLOON EXPANDABLE STENTS WITH SUCH AN OVERLAP THAT THE SELF-EXPANDABLE STENT GRAFTS WERE PRIMARILY REINFORCED AT THE LEVEL OF THE AORTIC LUMEN. AN ENDURANT TUBE GRAFT WAS DEPLOYED WITH THE PROXIMAL LANDING ZONE OF 3.9 CM FROM THE CELIAC TRUNK AND DISTAL LANDING ZONE 1 CM PROXIMAL TO THE MOST PROXIMAL RENAL ARTERY. THEN, THE 10F SHEATH FROM THE ARM WAS REPOSITIONED AND ADVANCED IN THE AORTIC EXTENDER CUFF, FROM WHICH BOTH RENAL ARTERIES WERE CATHETERIZED. THEREAFTER, ANOTHER MANUFACTURER¿S STENT GRAFTS WERE DEPLOYED IN BOTH RENAL ARTERIES PARTIALLY STRENGTHENED WITH BALLOON-EXPENDABLE BARE STENTS. ANOTHER MANUFACTURER¿S BIFURCATED STENT GRAFT WAS THEN DEPLOYED JUST BELOW THE PROXIMAL END OF THE CHIMNEYS IN THE RENALS AND WITH 3 CM OVERLAP WITH THE ENDURANT AORTIC CUFF, AND FINALLY, BOTH LIMBS WERE EXTENDED WITH EXTENSION GRAFTS. RESULTS: COMPLETION ANGIOGRAPHY SHOWED A SMALL TYPE III ENDOLEAK ORIGINATING FROM THE OVERLAP BETWEEN THE BIFURCATED GRAFT AND THE EXTENSION CUFF, AND AN EXPECTATIVE POLICY WAS CONDUCTED. ON THE SECOND POSTOPERATIVE DAY, A COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED GOOD PATENCY OF THE CHIMNEY GRAFTS AND A PERSISTENT TYPE III ENDOLEAK. HOSPITALIZATION WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY 4 IN GOOD HEALTH. FOLLOW-UP SCAN AFTER 4 MONTHS SHOWED ADEQUATE PATENCY OF ALL FOUR CHIMNEY GRAFTS WITH DISAPPEARANCE OF THE TYPE III ENDOLEAK EXCEPT FOR A SMALL TYPE II ENDOLEAK. DESPITE THE ENDOLEAK, THE MAXIMUM ANEURYSM DIAMETER HAD DECREASED FROM 66.0 TO 65.1 MM AND ANEURYSM VOLUME FROM 202.1 TO 161.8 ML. AFTER 1 AND 6 MONTHS, LABORATORY TESTING REVEALED NORMAL CREATININE LEVELS (111 AND 108 MMOL/L, RESPECTIVELY), AND THE PATIENT FELT WELL WITHOUT ABDOMINAL COMPLAINTS. CONCLUSIONS: SUPRARENAL PATHOLOGIES CAN BE TREATED WITH THE DOUBLE TWO-CHIMNEY TECHNIQUE USING DIRECTLY AVAILABLE DEVICES, WHICH OFFERS A BAILOUT IN PATIENTS NOT ELIGIBLE FOR A BRANCHED OR FENESTRATED STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608646 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR