BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2895683 · Received January 3, 2013

    Report

    Report Number
    2953200-2013-00019
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION, ANEURYSM RUPTURE); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFIED AND THROMBOSED VESSELS). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (CALCIFIED AND THROMBOSED VESSELS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE PROXIMAL AORTIC NECK WAS 28, 29, 32 MM IN DIAMETER FROM PROXIMAL TO DISTAL. THERE WAS MILD PROXIMAL NECK ANGULATION. MILD PROXIMAL NECK THROMBUS WITH NO CALCIFICATION. THE RIGHT AND LEFT ILIAC ARTERIES HAD MILD CALCIFICATION. THE ILIAC ARTERIES WERE TORTUOUS BILATERALLY. AN ENDURANT BIFURCATED STENT GRAFT (B)(4) WAS IMPLANTED FROM THE LEFT AND AN ENDURANT CONTRALATERAL LIMB (B)(4) WAS IMPLANTED FROM THE RIGHT SIDE INITIALLY WITHOUT COMPLICATION. IT WAS REPORTED THAT THREE DAYS LATER THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM. UPON ARRIVAL AT THE HOSPITAL, IMAGES DEMONSTRATED A PATENT ABDOMINAL STENT GRAFT WITH A LARGE TYPE IB ENDOLEAK. THE PHYSICIAN WAS UNABLE TO DETERMINE WHERE THE ENDOLEAK WAS ARISING FROM, BUT BELIEVED IT WAS COMING FROM THE LEFT LIMB. A 20 X 20 X 82 ENDURANT EXTENSION CUFF WAS SUCCESSFULLY PLACED. UPON FURTHER IMAGING IT WAS DISCOVERED THAT THE RIGHT ILIAC LIMB ALSO HAD A TYPE IB ENDOLEAK. THIS APPEARED TO BE THE LARGER OF THE TWO ENDOLEAKS. THE PREVIOUS STENT GRAFT WAS APPROXIMATELY 1CM FROM THE HYPOGASTRIC ARTERY AND THE PHYSICIAN DECIDED TO EMBOLIZE THE RIGHT INTERNAL ILIAC AND EXTEND THE LIMB INTO THE RIGHT EXTERNAL ILIAC ARTERY. FIVE COILS WHERE PLACED IN THE RIGHT INTERNAL ILIAC AND A 14F SHEATH WAS THEN ADVANCED IN THE RIGHT EXTERNAL ILIAC. A 16 X 13 X 124 ENDURANT LIMB WAS PLACED THROUGH THE 14F SHEATH AND DEPLOYED. FINAL IMAGES DEMONSTRATED NO EVIDENCE OF AN ENDOLEAK, BUT THERE WAS MODERATE THROMBUS IN THE RIGHT LIMB OF THE STENT GRAFT. NO HEPARIN WAS GIVEN DURING THE CASE BECAUSE THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL ANEURYSM. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE THROMBUS; HOWEVER, THE THROMBUS MIGRATED DOWN THE PATIENT'S RIGHT LEG. THE PHYSICIAN WAS ABLE TO RESTORE FLOW THROUGH THE GRAFT, BUT THE PATIENT DISTAL RUNOFF WAS OCCLUDED (RESTORED FLOW TO THE POPLITEAL). TWO DAYS LATER IT WAS REPORTED THAT THE PATIENT HAD AN ABOVE KNEE AMPUTATION. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    FILMS PRE-IMPLANT SHOW A 6.3 CM DIAMETER AAA WHICH CONTAINS THROMBUS AND CALCIFICATION. THE ILIACS ARE TORTUOUS BILATERALLY. THE REPORTED EVENTS AND STENT GRAFT CONFIGURATION COULD NOT BE ASSESSED SINCE FILMS POST-IMPLANT WERE NOT PROVIDED. THROMBUS FORMATION LIKELY DUE NO HEPARIN GIVEN DURING THE PROCEDURE FOR THE EMERGENT RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01732575

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention