BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2180831 · Received July 22, 2011

    Report

    Report Number
    2953200-2011-01321
    Event Type
    Death
    Date Received
    July 22, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (BALLOONING OUTSIDE OF THE STENT GRAFT). (HIGHLY ANGULATED NECK). (DEATH). (HIGHLY ANGULATED NECK). EVALUATION, CONCLUSION: (BALLOONING OUTSIDE OF THE STENT GRAFT). (HIGHLY ANGULATED NECK).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 80.5 MM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS A PROXIMAL NECK DIAMETER OF 24.2 MM; A DISTAL NECK DIAMETER OF 23.6 MM; PROXIMAL NECK LENGTH OF 10.0 MM; A MAXIMUM OUTER ANEURYSM DIAMETER OF 101.3 MM; A MAXIMUM LUMEN ANEURYSM DIAMETER OF 80.5 MM; A DISTAL AORTA DIAMETER OF 33.6 MM; A RENAL-AORTIC BIFURCATE LENGTH OF 158 MM; A LEFT COMMON PROXIMAL ILIAC DIAMETER OF 11.5 TO 15.8 MM; A LEFT COMMON DISTAL ILIAC DIAMETER OF 10 MM; A LEFT COMMON ILIAC LENGTH OF 35 MM; A RIGHT COMMON ILIAC DIAMETER OF 18.2 MM; A RIGHT COMMON DISTAL ILIAC DIAMETER OF 11.5 MM; A RIGHT COMMON ILIAC LENGTH OF 26 MM; A TOTAL ENDOGRAFT COVERED LENGTH, RIGHT SIDE OF 186 MM; A TOTAL ENDOGRAFT COVERED LENGTH, LEFT SIDE OF 195 MM; A MODERATELY TORTUOUS, SEVERELY CALCIFIED ILIAC ARTERIES WITH A HIGHLY ANGULATED NECK. IT WAS REPORTED THAT AS THE DELIVERY SYSTEM WAS BEING RETRIEVED, IT WAS NOTED THAT THE FIRST STENT STRUT GOT CAUGHT AND MOVED WITH THE NOSE CONE. THE STENT GRAFT WAS NOT FULLY FREED FROM THE DELIVERY SYSTEM; THEREFORE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE TAPER TIP TO RECAPTURE THE SPINDLE THOUGH THE BACK-END WHEEL WAS FULLY ADVANCED TO THE OPEN POSITION. (REF. MFR. 2953200-2011-01321). THE DEPLOYMENT DIFFICULTIES APPEARED TO BE RELATED TO THE ANATOMY; MOREOVER, DURING THE INITIAL INTRODUCTION OF THE MAIN BODY, THE DELIVERY SYSTEM MANAGED TO TRACK THROUGH THE ANATOMY SMOOTHLY WITHOUT ANY RESISTANCE OR SHOWING ANY SIGN OF KINKING. THE DEPLOYMENT PROCESS WAS ALSO SMOOTH; THE ONLY DIFFICULTY WAS DURING THE RECAPTURING OF SPINDLE DUE TO A HIGHLY ANGULATED NECK. A RELIANT BALLOON (REF. MFR. # 2953200-2011-01325) WAS USED TO TRY TO FREE THE SPINDLE. THE RELIANT BALLOON RUPTURED DURING INFLATION; HOWEVER, IT DID NOT RUPTURE ANY BLOOD VESSELS. A SECOND BALLOON WAS THEN USED FOR SEVERAL INFLATIONS; HOWEVER, THIS WAS UNSUCCESSFUL. DISASSEMBLY OF THE HANDLE WAS SIMILARLY INEFFECTIVE. FINALLY, SNARING THE NOSE CONE VIA A LEFT BRACHIAL ACCESS WAS SUCCESSFUL IN FREEING THE SPINDLE FROM THE SUPRARENAL STENT. FINALLY, SNARING THE NOSE CONE VIA A LEFT BRACHIAL ACCESS WAS SUCCESSFUL IN FREEING THE SPINDLE FROM THE SUPRARENAL STENT AND THE DEVICE WAS FULLY IMPLANTED. THE PHYSICIAN'S ASSESSMENT WAS THAT THE ISSUES WITH THE TIP CAPTURE HAD NOTHING TO DO WITH THE PLACEMENT OF THE STENT GRAFT AND THE FINAL OUTCOME OF THE PROCEDURE. THERE WAS A DISTAL TYPE I ENDOLEAK IN THE CONTRALATERAL LIMB WHICH RESOLVED WITH AN EXTENSION LIMB (REF. MFR. # 2953200-2011-01326). THE PATIENT WAS DOING FINE AT THE END OF THE PROCEDURE. THE PATIENT'S COURSE POST-OPERATIVELY WAS STORMY AND CHARACTERIZED BY SEVERE METABOLIC ACIDOSIS, HYPOTENSION, ANEMIA AND ACUTE RENAL FAILURE. THE PATIENT EXPIRED THREE DAYS AFTER THE IMPLANT (REF MFR. # 2953200-2011-01322, 2953200-2011-01323, 2953200-2011-01324). THE PHYSICIAN ALSO ASSESSED THAT TAKING INTO CONSIDERATION THE PATIENT'S OVERALL HEALTH STATUS, AND HIS AGE, EVAR WAS A BETTER OPTION FOR ANEURYSM REPAIR THAN AN OPEN SURGERY PROCEDURE. AN INTERNAL FIRM REVIEW OBSERVED THE FOLLOWING: THE ANEURYSM IS LARGE, WITH BLOOD FLOW MEASURING 9.5 CM IN ITS LARGEST CROSS SECTION. THE ILIAC VESSELS ARE ALSO VERY TORTUOUS AND HIGHLY CALCIFIED. THE PROXIMAL AORTIC NECK IS ABOUT 54 MM IN LENGTH AND CALCIFIED, AND THE INFRARENAL ANGULATION - FORMED BY THE TAKEOFF OF THE RENAL ARTERIES, THE START OF ANEURYSM, AND AORTIC BIFURCATION - IS APPROXIMATELY 85 DEGREES. THE INTRA-OPERATIVE ANGIOGRAMS SHOW THAT THE DELIVERY SYSTEM IS BIASED TOWARD THE RIGHT AORTIC WALL AT THE PROXIMAL AORTIC NECK AND BIASED TOWARD THE LEFT WALL AT THE DISTAL AORTIC NECK. FURTHERMORE, THE INTRA-OPERATIVE ANGIOGRAMS SHOW THE FOLLOWING SEQUENCE OF DELIVERY SYSTEM MANEUVERS: THE ADVANCEMENT OF THE DELIVERY SYSTEM PRIOR TO DEPLOYMENT; THE RELEASE OF THE SUPRARENAL STENTS; A STENT APEX CAUGHT BETWEEN THE SPINDLE AND THE SPINDLE SLEEVE AFTER HAVING RECAPTURED THE NOSE CONE; SNARING OF THE NOSE CONE VIA BRACHIAL ACCESS; AND POST-WITHDRAWAL OF THE ENDURANT BIFURCATED DELIVERY SYSTEM. HOWEVER, AS THERE WERE NO INTRA-OPERATIVE IMAGES SHOWING THE RECAPTURING OF THE SPINDLE OR THE CATCHING OF THE SPINDLE/NOSE CONE ON THE SUPRARENAL STENTS, OUR INVESTIGATION INTO THE EXACT ROOT CAUSE OF THE REMOVAL DIFFICULTIES IS LIMITED. ACCORDING TO THE DEATH CERTIFICATE, THE IMMEDIATE CAUSE OF DEATH WAS SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, WITH AN ANTECEDENT CAUSE OF SHOCK AND ACUTE RENAL FAILURE WITH SEVERE METABOLIC ACIDOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00801489

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death