BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3484217 · Received November 22, 2013

    Report

    Report Number
    2953200-2013-02298
    Event Type
    Injury
    Date Received
    November 22, 2013
    Date of Event
    November 12, 2012
    Report Date
    October 30, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (RENAL FAILURE); OTHER (UNKNOWN CAUSE OF EVENT). CONCLUSION: OTHER (UNKNOWN CAUSE OF EVENT); KNOWN INHERENT RISK OF A PROCEDURE (RENAL FAILURE).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED TECHNICAL CONSIDERATIONS AND RESULTS OF CHIMNEY GRAFTS FOR THE TREATMENT OF JUXTARENAL ANEURYSMS. JIP L. TOLENAAR. J VASC SURG 2013;58:607-15.) ON AN UNKNOWN DATE, AN UNKNOWN ENDURANT STENT GRAFT (PLI-10) WAS IMPLANTED IN THE PATIENT FOR THE TREATMENT OF A 7.2 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. PATIENT NUMBER 13: THE PATIENT DEVELOPED ACUTE RENAL FAILURE (MAXIMAL CREATININE, 711 MMOL/L), HE WAS SUBMITTED TO THE INTENSIVE CARE UNIT FOR HEMODIALYSIS AFTER WHICH CREATININE LEVELS STABILIZED TO 212 MMOL/L (GLOMERULAR FILTRATION RATE, 27 ML/MIN/1.73 M2) AT DISCHARGE. OBJECTIVE: TO PRESENT OUR INITIAL EXPERIENCE AND TECHNICAL CONSIDERATIONS FOR THE USE OF CHIMNEY GRAFTS IN THE TREATMENT OF PATIENTS THAT REQUIRE ENDOVASCULAR ANEURYSM REPAIR WITH AORTIC BRANCH PRESERVATION. METHODS: ALL PATIENTS TREATED WITH A CHIMNEY PROCEDURE BETWEEN OCTOBER 2009 AND JUNE 2011 WERE INCLUDED IN OUR ANALYSES. CHIMNEY PROCEDURES WERE ONLY PERFORMED IN PATIENTS THAT WERE UNSUITABLE FOR OPEN REPAIR AND WITHOUT OPPORTUNITY TO USE FENESTRATED GRAFTS (BECAUSE OF UNSUITABLE ANATOMY OR EMERGENCY OPERATION). OPEN BRACHIAL OR AXILLARY ACCESS WAS USED TO DEPLOY COVERED CHIMNEY GRAFTS IN THE TARGET VESSELS, AND SUBSEQUENTLY, A STENT GRAFT WAS DEPLOYED VIA FEMORAL CUT-DOWN ACCESS. RESULTS: THIRTEEN PATIENTS (12 MALES; MEAN AGE, 77.2 6 6.2 YEARS; MEAN MAXIMAL DIAMETER, 71.4 6 10.2 MM) UNDERWENT A CHIMNEY PROCEDURE WITH THE PRESERVATION OF 22 AORTIC SIDE BRANCHES. PRIMARY TECHNICAL SUCCESS WAS 92.3% DUE TO OCCLUSION OF ONE RENAL ARTERY WITHIN 24 HOURS. THIRTY-DAY MORTALITY WAS 0%. INFRARENAL MEAN NECK LENGTH WAS 2.6 MM 6 3.2 MM (RANGE, 0-8 MM) AND COULD BE EXTENDED TO 27.3 MM 6 9.9 MM (RANGE, 18-53 MM) BY THE USE OF CHIMNEY GRAFTS. DURING FOLLOW-UP (MEDIAN, 10.8 MONTHS; INTERQUARTILE RANGE, 7.4-19.4), ONE PATIENT DIED FROM COMPLICATIONS FROM MESENTERIC ISCHEMIA BASED ON A STENOSIS OF THE CELIAC TRUNK ATTRIBUTABLE TO THE BARE STENT OF THE STENT GRAFT, AND ONE PATIENT DIED FROM ANEURYSM RUPTURE. OTHER COMPLICATIONS INCLUDED LATE OCCLUSION OF ONE RENAL ARTERY AND A TYPE II ENDOLEAK, WHICH WAS UNSUCCESSFULLY TREATED WITH COIL EMBOLIZATION AND REQUIRED LAPAROTOMY. IF WE DISREGARD THE RUPTURED PATIENT WHO HAD AN ENORMOUS INCREASE OF ANEURYSM DIAMETER, MEAN AORTIC ANEURYSM DIAMETER REDUCED FROM 70.7 6 10.3 MM (RANGE, 54-89 MM) TO 66.7 6 13.9 MM (RANGE, 48-96 MM) DURING FOLLOW-UP (P [ .13). IN THREE PATIENTS, THE ANEURYSM DIAMETER DECREASED BY MORE THAN 5 MM AND IN TWO PATIENTS, THE DIAMETER INCREASED BY MORE THAN 5 MM. THE ANEURYSM DIAMETER REMAINED STABLE IN THE OTHER EIGHT PATIENTS. CONCLUSIONS: UNTIL OFF-THE-SHELF FENESTRATED OR BRANCHED STENT GRAFTS BECOME AVAILABLE, THE CHIMNEY PROCEDURE OFFERS A MINIMALLY INVASIVE TREATMENT OPTION IN PATIENTS REQUIRING ANEURYSM EXCLUSION WITH SIDE BRANCH REVASCULARIZATION. ALTHOUGH LONG-TERM FOLLOW-UP HAS TO BE AWAITED, THE INITIAL RESULTS SHOW THAT CHIMNEY GRAFTS CAN HELP TO DECREASE OR STABILIZE THE ANEURYSM DIAMETER IN MOST PATIENTS, BUT ANEURYSM RUPTURE WAS NOT PREVENTED IN ALL PATIENTS. (J VASC SURG2013;58:607-15.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609124 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR