BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3182183 · Received June 21, 2013

    Report

    Report Number
    2953200-2013-01168
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 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). RESULTS: INHERENT RISK OF PROCEDURE (CARDIAC TAMPONADE). CONCLUSIONS: KNOWN INHERENT RISK OF A PROCEDURE (CARDIAC TAMPONADE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM ABDOMINAL AORTIC ANEURYSM. THE MAXIMUM ANEURYSM DIAMETER WAS 48MM. THE PROXIMAL AORTIC NECK WAS 19-20MM IN DIAMETER AND 13MM LONG. THE RIGHT COMMON ILIAC ARTERY WAS 28-17MM IN DIAMETER, AND THE LEFT COMMON ILIAC ARTERY WAS 30-24MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY WAS 7MM IN DIAMETER, AND THE LEFT WAS 6MM IN DIAMETER. THE RIGHT AND LEFT ILIAC ARTERIES WERE SEVERELY TORTUOUS. THE MEDICAL HISTORY WAS NOT REPORTED. IT WAS REPORTED THAT ANOTHER MANUFACTURER¿S GUIDE WIRES WERE USED BILATERALLY DUE TO THE SEVERE ILIAC TORTUOSITY. ALL FOUR ENDURANT DEVICES WERE IMPLANTED AND REMODELED USING ANOTHER MANUFACTURER¿S BALLOON. AFTER FINAL ANGIOGRAPHY, THE PATIENT¿S MEAN ARTERIAL PRESSURE WAS 43 MMHG AND WOULD NOT RISE. THERE WAS NO EVIDENCE OF AN ENDOLEAK AND NO EVIDENCE OF A DISSECTION. IT WAS THEN DISCOVERED THAT THE PATIENT HAD DEVELOPED CARDIAC TAMPONADE. THE EXCESS FLUID WAS DRAINED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE AND TRANSFERRED TO THE ICU. THE PHYSICIAN STATED THAT THE CARDIAC TAMPONADE WAS CAUSED BY A PERFORATION FROM A GUIDE WIRE. NO ADDITIONAL INFORMATION REGARDING THE CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283254 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04031623

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention