BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3252211 · Received July 29, 2013

    Report

    Report Number
    2953200-2013-01463
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    April 13, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSIONS: (PRE-OPERATIVE RUPTURE). (ENDOLEAK, RESPIRATORY FAILURE, LYMPHOCELE). (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. USE OF THE ENDURANT STENT GRAFT SYSTEM FOR RUPTURED INFRARENAL AORTIC ANEURYSMS: SHORT-TERM EXPERIENCE IN NINE PATIENTS. YUYA KOIKE, MD, JUN-ICHI NISHIMURA, MD, PHD, HIROSHI NISHIMAKI, MD, PHD, SOICHIRO HASE, MD, PHD, NOBUKAZU MORIYA, MD, SUSUMU OSHIMA, MD, TAKUYA FUJIKAWA, MD, AND YUJI SEKINE, MD. J VASC INTERV RADIOL 2013. HTTP://DX.DOI.ORG/10.1016/J.JVIR.2013.04.020, PATIENT 4: IT WAS REPORTED THAT AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM DIAMETER WAS 69 MM. COIL EMBOLIZATION MAY HAVE BEEN PERFORMED BECAUSE OF THE POSSIBLE PRESENCE OF A CONCOMITANT ILIAC ANEURYSM. THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND VITAL SIGNS INDICATING SHOCK. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: RESPIRATORY FAILURE, LYMPHOCELE. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. PURPOSE: TO REPORT THE EARLY RESULTS OF USE OF THE ENDURANT STENT GRAFT IN THE TREATMENT OF RUPTURED ABDOMINAL AORTIC ANEURYSMS (AAAS). MATERIALS AND METHODS: NINE CONSECUTIVE PATIENTS (SEVEN MEN AND TWO WOMEN; MEAN AGE, 76Y; RANGE,65¿87 Y) UNDERWENT ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR A RUPTURED AAA WITH THE ENDURANT STENT GRAFT BETWEEN APRIL AND DECEMBER 2012. EVAR WAS EMERGENT IN ALL CASES. EARLY TECHNICAL SUCCESS, CLINICAL SUCCESS, MAJOR COMPLICATION, AND MORTALITY RATES WERE ANALYZED. RESULTS: INTRAOPERATIVE IMMEDIATE TECHNICAL SUCCESS WAS ACHIEVED IN ALL NINE PATIENTS. THE 30-DAY CLINICAL SUCCESS RATE WAS 67% (SIX OF NINE PATIENTS). THE 30-DAY MORTALITY RATE WAS 33% (THREE OF NINE PATIENTS). DURING A MEAN FOLLOW-UP OF 6 MONTHS (RANGE, 3¿10 MO), NONE OF THE CASES REQUIRED REINTERVENTION; THERE WAS ONE LATE DEATH ATTRIBUTED TO PROBABLE ENDOGRAFT INFECTION. CONCLUSIONS: THE SHORT-TERM RESULTS OF EVAR WITH THE ENDURANT STENT GRAFT IN PATIENTS WITH RUPTURED AAAS ARE ENCOURAGING. DISCUSSION: A POTENTIAL DISADVANTAGE OF THE ENDURANT STENT GRAFT IS THAT TYPE IV ENDOLEAKS WERE OBSERVED IN 67% (SIX OF NINE) OF PATIENTS ON COMPLETION ANGIOGRAPHY. A TYPE IV ENDOLEAK IS DEFINED AS BLOOD FLOW THROUGH AN INTACT BUT OTHERWISE POROUS FABRIC OBSERVED DURING THE FIRST 30 DAYS AFTER GRAFT IMPLANTATION. THE OCCURRENCE RATE OF 12% (18 OF150) WAS REPORTED IN A U.S. REGULATORY STUDY. THE POLYESTER FABRIC AND SEWING PINHOLE OF THE ENDURANT STENT GRAFT IS SUSPECTED TO BE A CAUSE OF THESE ENDOLEAKS. IN ELECTIVE CASES, TYPE IV ENDOLEAKS ARE OF RELATIVELY MINOR IMPORTANCE IN THE CLINICAL SETTING. HOWEVER, IN RUPTURED AAAS, TYPE IV ENDOLEAKS CARRY THE RISK OF ONGOING BLEEDING AND ABDOMINAL COMPARTMENT SYNDROME. FURTHER INVESTIGATIONS OF TYPE IV ENDOLEAKS IN THE ENDURANT STENT GRAFT PROCEDURES ARE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353647 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention