BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3013231 · Received March 20, 2013

    Report

    Report Number
    2953200-2013-00493
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: (FILM). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY RUPTURED ANEURYSM). UNAPPROVED USE OF DEVICE (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY RUPTURED ANEURYSM). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED 70 MM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE VESSELS WERE MODERATELY TORTUOUS WITH MODERATE CALCIFICATION. THE BIFURCATED STENT GRAFT WAS IMPLANTED AND ALL SEEMED FINE ON THE FINAL RUN; HOWEVER, THE PATIENT'S SYMPTOMS OF STOMACH PAIN CONTINUED AFTER STENT GRAFT PLACEMENT AND THE PATIENT HAD SOME BLEEDING FROM AN UNKNOWN LOCATION. THE PATIENT WAS TAKE BACK TO OPERATING ROOM OPENED THE PATIENT AND THERE WAS BLOOD SEEN LEAKING THROUGH THE MAIN BODY OF THE STENT GRAFT MATERIAL. IT WAS APPROXIMATELY 10MM DISTAL TO THE AORTIC BIFURCATION. THE STENT GRAFT WAS SUTURED IN AN ATTEMPT TO ADDRESS THE ENDOLEAK. THIS REDUCED THE ENDOLEAK BUT DID NOT COMPLETELY RESOLVE IT. IT WAS CONFIRMED THAT THE ENDOLEAK RESOLVED AT A LATER FOLLOW-UP; HOWEVER, THE PATIENT HAS HAD OTHER COMPLICATIONS RELATED TO THE ANEURYSM RUPTURE. THE PATIENT HAD BLOOD CLOTTING DISORDERS. A NORMAL AMOUNT OF HEPARIN WAS USED DURING THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. REVIEW OF RETURNED ANGIO IMAGES AT IMPLANT SHOW THAT THE BIFURCATE IPSILATERAL LIMB WAS PLACED ON THE LEFT SIDE. THE CONTRALATERAL WAS PLACED WITH CORRECT GATE OVERLAP. NO OBVIOUS ENDOLEAKS WERE SEEN POST-BALLOONING THE ENTIRE STENT GRAFT. AN EXTENSION WAS PLACED IN BOTH THE RIGHT AND LEFT LIMBS; NO ENDOLEAK OR OTHER STENT GRAFT ISSUES WERE SEEN AT THE FINAL ANGIO IMAGE. THE CAUSE OF THE FABRIC ENDOLEAKS SEEN POST-IMPLANT WHEN THE PATIENT WAS OPENED COULD NOT BE DETERMINED, AND IMAGES OF THE REPORTED LEAK WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116292 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01712544

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention