BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY

    MDR report key: 3723920 · Received February 24, 2014

    Report

    Report Number
    9680654-2014-00003
    Event Type
    Death
    Date Received
    February 24, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 20, 2014
    Manufacturer
    WILLIAM COOK AUSTRALIA
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS.

    Description of Event or Problem · 1

    THE PT EXPIRED DUE TO BOWEL ISCHEMIA. PT UNDERGOING IMPLANTATION OF ZENITH FENESTRATED ENDOVASCULAR STENT GRAFT IN THE ABDOMINAL AORTA. THE DEVICE WOULD INVOLVE THE SUPRA-RENAL AND INFRA-RENAL SEGMENT OF THE AORTA. PER STANDARD PROCEDURE BOTH OF THE PT'S COMMON FEMORAL ARTERIES WERE EXPOSED AND ACCESSED VIA A WIRE GUIDE AND SHEATH. ONCE THE ANGIOGRAM HAD BEEN PERFORMED (OF NOTE SMA FILLED, BUT VERY FAINTLY AND SLUGGISH PRIOR TO INTRODUCTION OF THE STENT GRAFT) USING PIG-TAIL CATHETER CONFIRMING POSITION OF RENAL ARTERIES, THE PROXIMAL BODY WAS INTRODUCED. CARE WAS TAKEN PRIOR TO INTRODUCTION OF DEVICE TO RE-CONFIRM DEVICE ORIENTATION AND FENESTRATION POSITIONS UNDER FLUOROSCOPY. DEVICE WAS INTRODUCED WITHOUT ISSUES AND FENESTRATIONS WERE POSITIONED AT/NEAR RENAL ARTERY OSTIUM(S). PROXIMAL DEVICE WAS THEN UNSHEATHED UNTIL OPEN FROM BELOW AND PROXIMAL BODY WAS CANNULATED FROM THE CONTRALATERAL SIDE WITH GLIDE WIRE AND CATHETER. LUNDERQUIST WIRE WAS EXCHANGED VIA CATHETER AND CONTRALATERAL SHEATH WAS ADVANCED WITH DILATOR INTO THE PROXIMAL BODY WITHOUT INCIDENT. HIFLEX ANSEL 1 SHEATHS WERE INTRODUCED THROUGH SEPARATE PUNCTURES IN THE 20FR SHEATH AND ADVANCED TO THE LEVEL OF THE RENAL FENESTRATIONS. THE RIGHT LOWER RENAL WAS CANULATED THROUGH THE RIGHT SMALL 6X8 FENESTRATION WITH A .014 BOSTON SCIENTIFIC JOURNEY WIRE. BALLOON ANGIOPLASTY WAS PERFORMED ON THIS RENAL DUE TO PLAQUE LESION, THUS ALLOWING .035 WIRE GUIDES AND CATHETERS TO PASS. A 260CM ROSEN WIRE GUIDE DID PASS THROUGH THE LESION AND REMAINED IN THE RENAL AS THE PHYSICIAN BEGAN TO CANULATE THE LEFT (HIGHER) RENAL ARTERY. OF NOTE DURING THIS PART OF THE PROCEDURE, A CLOT WAS OBSERVED IN THE HEMOSTATIC VALVE OF THE UNSHEATHED PROXIMAL BODY. ACTS WERE TAKEN AND CAME BACK LOWER THAN EXPECTED. MORE HEPARIN WAS GIVEN, BUT THE ACTS STILL SEEMED LOW. FFP AND THROMBATE WERE BOTH ADMINISTERED TO THE PT. CASE CONTINUED ON AND LEFT RENAL ARTERY WAS CANULATED WITHOUT TOO MUCH DIFFICULTY. BOTH HIFLEX ANSEL 1 SHEATHS WERE PLACED IN THE LEFT AND RIGHT RENAL ARTERY AND ATRIUM CAST 5X22 (RIGHT) AND 6X22 COVERED STENTS WERE PLACED IN RENAL SHEATHS. WITH STENTS IN BOTH RENALS, THE PROXIMAL BODY DEVICE DIAMETER REDUCING TIES WERE DEPLOYED, THE PROXIMAL TRIGGER WIRE RELEASE MECHANISM WAS PULLED OFF THE DELIVERY SYSTEM, AND THE TOP CAP WAS ADVANCED DEPLOYING ACTIVE FIXATION OF THE BARE METAL STENT. A CODA BALLOON WAS USED TO BALLOON SEAL ZONE (FIRST TWO STENTS). BOTH STENTS WERE DEPLOYED IN THE RENALS WITHOUT INCIDENT AND FLARED WITH 8X2CM ANGIO BALLOON. SHEATHS WERE RE-INTRODUCED INTO DEPLOYED RENAL STENTS AND CONTRAST WAS INJECTED INTO SHEATH TO VISUALIZE RENAL ARTERY AND FLOW. NITROGLYCERIN WAS INJECTED THROUGH THE SHEATHS INSIDE THE RENALS. RENAL GRAMS SHOWED GOOD FLOW. WIRES AND SHEATHS WERE PULLED OUT OF THE RENALS AND THE UNIVERSAL DISTAL BODY DEVICE WAS INTRODUCED (ONCE THE PROXIMAL BODY SHEATH SYSTEM WAS REMOVED). DISTAL DEVICE WAS INTRODUCED WITHOUT INCIDENT AND MAXIMUM (54MM+) OVERLAP WAS OBTAINED. DEVICE WAS DEPLOYED DOWN TO DISTAL END OF IPSILATERAL STENT. CONTRALATERAL GATE WAS CANULATED WITHOUT INCIDENT AND A BALLOON WAS USED TO CONFIRM THE WIRE WAS INSIDE THE DISTAL BODY. CONTRALATERAL ZSLE LIMB WAS INTRODUCED AND DEPLOYED WITHOUT INCIDENT. ANOTHER ZSLE IPSILATERAL LIMB WAS INTRODUCED THROUGH THE DISTAL BODY SHEATH AND DEPLOYED WITHOUT INCIDENT. FINAL GRAFT-O-GRAM REVEALED NO ENDOLEAK(S) AND BOTH LEFT AND RIGHT RENAL ARTERIES WERE VISUALIZED. SMA WAS NOT VISUALIZED UPON FINAL COMPLETION GRAFT-O-GRAM. AS PHYSICIANS WERE CLOSING, THE PT'S GROIN RIGHT LEG WAS DETERMINED TO NOT HAVE A PULSE. PLAQUE WAS RETRIEVED FROM THE RIGHT AND PULSE WAS RESTORED. THE PT WAS EMERGENTLY BROUGHT BACK INTO THE OPERATING ROOM ON (B)(6) AND A #3 FOGARTY BALLOON WAS INTRODUCED INTO THE SMA. NO CLOT OR MATTER WAS OBSERVED TO BE PULLED OUT OF THE SMA. A SELF EXPANDING STENT WAS PLACED INTO THE SMA IN A LATERAL VIEW (C-ARM) AND IT WAS OBSERVED BY PHYSICIAN THAT THE DEVICE AT THE LEVEL OF THE 10X12 SCALLOP DID MOVE. PT EXPIRED DUE TO BOWEL ISCHEMIA. IT IS UNK IF THE PLACEMENT OF THE SCALLOP OF THE PROXIMAL BODY DEVICE PLAYED ANY ROLE IN THE SMA OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112944 ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY NONE MIH WILLIAM COOK AUSTRALIA AC931663

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death