BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 8289120 · Received January 30, 2019

    Report

    Report Number
    1820334-2019-00269
    Event Type
    Injury
    Date Received
    January 30, 2019
    Date of Event
    January 8, 2019
    Report Date
    April 17, 2019
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002552422
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION/EVALUATION THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. IMAGING WAS PROVIDED FOR REVIEW. A DOCUMENT BASED INVESTIGATION HAS BEEN PERFORMED INCLUDING A REVIEW OF THE PROVIDED IMAGING, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCE'S WERE FOUND ASSOCIATED WITH LOT 8549729. GRAFT SUB-ASSEMBLY LOT SA7968739 WAS REVIEWED AND NO NON-CONFORMANCE'S WERE FOUND. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS THE DEVICE WAS NOT EXPLANTED FROM THE PATIENT. PRE-IMPLANTATION CTA WAS PROVIDED FOR THIS CASE. NO POST-IMPLANTATION IMAGING WAS AVAILABLE. THE RELEVANT FINDINGS FROM THE IMAGE REVIEW ARE: 2. THE LESION WAS PRIMARILY A LARGE FUSIFORM RIGHT CIA ANEURYSM DOWNSTREAM OF A BORDERLINE SMALL 39MM MAXIMAL DIAMETER INFRARENAL ANEURYSM. THE AORTIC ANEURYSM TERMINATED AT AN 80-DEGREE ACUTE AORTIC BEND POSITIONED MID-WAY BETWEEN THE RIGHT RENAL ARTERY ORIGIN AND THE AORTIC BIFURCATION. HERE, THE AORTIC LUMEN WAS FOCALLY NARROWED TO 21.3MM X 24.2MM. THE DISTAL HALF OF THE INFRARENAL ABDOMINAL AORTA PAST THE BEND WAS GENERALLY ROUND AND 27MM IN LUMEN DIAMETER. 4. THE LEFT CIA WAS SEVERELY TORTUOUS WITH A 1.4 TORTUOSITY INDEX. THE RIGHT CIA MADE A 9- DEGREE BEND WITHIN 15MM OF THE AORTIC BIFURCATION. 6. BASED ON THE AORTIC LENGTH, ZIMB MAINBODY LENGTHS OF 70MM AND 84MM WOULD HAVE LIKELY PEEN IMPLANTED. A 98MM LONG ZIMB WOULD HAVE LIKELY BEEN CONSIDERED TOO LONG AS ITS CONTRALATERAL GATE WOULD HAVE OPENED AT THE AORTIC BIFURCATION. EITHER A 70MM OR 84MM LENGTH ZIMB WOULD HAVE ALLOWED AT LEAST A 20MM ZSLE-20-74 SEAL IN THE LEFT CIA. 7. BECAUSE OF THE REVERSE FUNNEL NECK, AT LEAST A 32MM ZIMB AND MORE LIKELY A 36MM ZIMB DIAMETER WOULD HAVE LIKELY BEEN IMPLANTED. 8. THE TAPERED DISTAL STENT BODY OF AN 80MM LONG ZIMB WOULD HAVE LANDED AT THE NARROW AORTIC BEND WHILE THE FULL MAINBODY DIAMETER OF A 94MM LONG ZIMB WOULD HAVE LANDED ACROSS THE BEND. 9. EITHER CHOICE PRESENTED CHALLENGES. 94MM MAINBODY CONSTRAINT AT THE BEND MAY HAVE BEEN RELIEVABLE WITH ANGIOPLASTY AND OR ADDITIONAL STENTING. HOWEVER, THE BEND AND ITS PROXIMITY TO THE FUNNELING DISTAL MAINBODY STENTS AND THE FLOW DIVIDER WOULD HAVE MADE THIS DIFFICULT. A TAPERING 80MM MAINBODY WOULD HAVE BETTER FIT THE NARROWING. HOWEVER, BECAUSE THE FLOW DIVIDER STENT WOULD HAVE BEEN PLACED IMMEDIATELY BELOW THE NARROWED BEND, INFLOW INTO THE FLOW DIVIDER STENT GATES WOULD HAVE BEEN MORE TURBULENT AND POSSIBILITY RESTRICTED. BECAUSE THE IPSILATERAL GATE WOULD HAVE LIKELY BEEN POSITIONED ON THE INNER SIDE OF THE BEND, ITS INFLOW WAS AT GREATER RISK. THE IMAGE REVIEW CONCLUDED THE COMPLAINT OF IPSILATERAL ZSLE THROMBOSIS CANNOT BE CONFIRMED AS IMAGING OF THE COMPLAINT EVENT WAS NOT PROVIDED. THE ANATOMY, SPECIFICALLY A NARROW MID AORTIC 80-DEGREE BEND AND SEVERE LEFT CIA TORTUOSITY, PRESENTED CHALLENGES TO PATENCY. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: THE ZSLE-20-74-ZT IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU). THE IFU LISTS THE FOLLOWING INSTRUCTIONS: INDICATIONS FOR USE: ¿ THE ZENITH SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRAK INTRODUCTION SYSTEM IS INDICATED FOR USE WITH THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS, INCLUDING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT, ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT, ZENITH RENU ANCILLARY GRAFT, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT, ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT, ZENITH FLEX AUI, OR ZENITH BRANCH ILIAC ENDOVASCULAR GRAFT, DURING EITHER A PRIMARY OR A SECONDARY PROCEDURE IN PATIENTS WHO HAVE ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS. THE GRAFT IS USED IN COMBINATION WITH THESE PRODUCTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS. WARNINGS AND PRECAUTIONS: ¿ PATIENTS EXPERIENCING EDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/ OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. ¿ ADEQUATE ILIAC OR FEMORAL ACCESS IS REQUIRED TO INTRODUCE THE DEVICE INTO THE VASCULATURE. ACCESS VESSEL DIAMETER (MEASURED INNER WALL TO INNER WALL) AND MORPHOLOGY (MINIMAL TORTUOSITY, OCCLUSIVE DISEASE AND/OR CALCIFICATION) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEMS OF A 14 FRENCH TO 16 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. PRE-EXISTING REGIONS OF STENOSIS/NARROWING (LESS THAN APPROXIMATELY 20 MM ID IN THE AORTA OR 7 TO 8 MM ID IN THE ILIAC'S) HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). THE POTENTIAL FOR THIS INCREASED RISK IN THESE PATIENTS MAY PRECLUDE PLACEMENT OF AN ENDOVASCULAR GRAFT. DILATION OF THESE REGIONS WITH A NONCOMPLIANT BALLOON AND/OR STENT PLACEMENT MAY BE NECESSARY TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. FOLLOW-UP IMAGING SHOULD BE CAREFULLY REVIEWED FOR NARROWING WITHIN THE GRAFT LEG. PATIENT WITH A GRAFT LEG LUMEN OF LESS THAN APPROXIMATELY 5 MM ID MAY BE AT INCREASED RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). REINTERVENTION (E.G., NONCOMPLIANT BALLOONING OR STENTING IN THESE REGIONS) SHOULD BE CONSIDERED TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. PATIENT WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE (E.G., CANCER) MAY BE AT AN INCREASED RISK OF A THROMBOEMBOLIC EVENT. EXCESSIVE OVERLAP OF 10 MM ABOVE THE MAIN BODY GRAFT BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS. DIRECTIONS FOR USE: SECTION 11.1.5: IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT 2. ADVANCE SLOWLY UNTIL THE IPSILATERAL ILIAC LEG GRAFT OVERLAPS A MINIMUM OF ONE STENT INSIDE THE IPSILATERAL LIMB OF THE MAIN BODY. POTENTIAL ADVERSE EVENTS: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDOANEURYSM. CLAUDICATION (E.G., BUTTOCK, LOWER LIMB). GRAFT OR NATIVE VESSEL OCCLUSION. THERE ARE ADEQUATE INSTRUCTIONS AND WARNINGS TO FACILITATE PROPER PLACEMENT AND USE OF THE DEVICE. POST-IMPLANTATION CTA WAS NOT AVAILABLE, SO THE EXACT NATURE AND CAUSE OF THE OCCLUSION CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. THERE IS NO EVIDENCE THE DEVICE WAS INCORRECTLY PLACED WITHIN THE PATIENT, OR THAT THE DEVICE WAS KINKED OR INFOLDED. IT WAS STATED WITHIN THE PRE-IMPLANTATION IMAGE REVIEW THAT THERE WAS SEVERE TORTUOSITY OF THE LEFT CIA, AS WELL AS A NARROW 80-DEGREE BEND MID-AORTA. THIS PRESENTS CHALLENGES TO PATENCY OF THE ARTERIES, AND AS THE BLOOD FLOW THROUGH THE LUMEN SLOWS DOWN, THERE IS AN INCREASED CHANCE OF CLOTTING. ALTHOUGH THESE OBSERVATIONS WERE MADE PRE-IMPLANTATION, IT IS POSSIBLE THAT THE PATIENT ANATOMY CONTRIBUTED TO THIS EVENT. THE MAIN BODY GRAFT USED IN THIS PROCEDURE WAS A ZIMB-28-84 GRAFT. BASED ON THE PRE-IMPLANTATION CTA, THE IMAGE REVIEW CONCLUDED THAT A 70 TO 84 MM LONG, 32 TO 36MM WIDE GRAFT WOULD HAVE BEEN IMPLANTED AS THE MAIN BODY. THE PLANNING AND SIZING SHEET WAS NOT PROVIDED FOR THIS CASE. ALTHOUGH THROMBUS OR OCCLUSION WAS NOT REPORTED FOR THE MAIN BODY GRAFT, THE SMALLER DIAMETER OF THE GRAFT COMPARED TO THE EXPECTED COULD HAVE CONTRIBUTED TO THE SLOWING OF BLOOD FLOW INTO THE TORTUOUS ANATOMY OF THE LEFT LIMB. IT IS LIKELY THIS COMBINATION OF FACTORS CONTRIBUTED TO THE OCCLUSION OF THE LEFT LIMB. IT IS POSSIBLE AN UNINTENDED USE ERROR CONTRIBUTED TO THIS EVENT. A DEFINITIVE CONCLUSION COULD NOT BE ESTABLISHED. A QUALITY ENGINEER RISK ASSESSMENT WAS CONDUCTED TO ASSESS THE RISK OF THIS FAILURE MODE AND CONCLUDED A CHANGE IS NOT REQUIRED, THUS NO RISK REDUCTION ACTIVITIES ARE REQUIRED AT THIS TIME. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THERE HAS BEEN NO NEW PATIENT/EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 04FEB2019.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS AN OCCLUSION OF THE LEFT (IPSILATERAL) LIMB. THE PATIENT DEVELOPED LEG PAIN AND DOPPLER SHOWS AN OCCLUDED LEFT EVAR LIMB. IT WAS REPORTED THAT THEY ARE WAITING CT RESULTS AT THIS TIME. PATIENT WAS SYMPTOMATIC AND REQUIRED HOSPITAL ADMISSION. THE PATIENT PRESENTED WITH LEG PAIN ON (B)(6) 2019. NO ADDITIONAL PROCEDURES HAVE BEEN COMPLETED AT THIS TIME. THE PATIENT IS TAKING ASPIRIN AND HAD A PRE-EXISTING LARGE ILIAC ANEURYSM THAT WAS TREATED WITH A ILIAC BRANCH GRAFT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 04FEB2019. THE MAIN BODY DEVICE IMPLANTED IN THE PATIENT IS A (B)(6), LOT 8932092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82196 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC G55242 8549729 10827002552422

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization