BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8591994 · Received May 8, 2019

    Report

    Report Number
    1820334-2019-01084
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    October 24, 2018
    Report Date
    June 6, 2019
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002552323
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION/EVALUATION THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. 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. PER THE IMAGING REVIEWER, ON THE RIGHT, A ZSLE-13-74 (ZSLE-13-74-ZT) EXTENDED FROM THE FLOW DIVIDER TO THE RIGHT CIA OSTIUM. THE RIGHT ILIAC LEG WAS THEN SEALED WITH A ZSLE-16-74 IN THE DISTAL RIGHT CIA JUST PROXIMAL THE IIA ORIGIN. THE SUPERIOR END OF THE ZSLE-16-90 WAS CONSTRAINED TO 9MM. AT THIS POINT, BECAUSE IT WAS INSIDE BOTH THE CONTRALATERAL GATE AND ZSLE-13-74 (ZSLE-13-74-ZT), IT MAY HAVE BEEN CONSTRAINED BY REDUNDANT FABRIC FROM THE ZSLE-13-74 (ZSLE-13-74-ZT). DESPITE THE ABRUPT NARROWING, IMMEDIATE DOWNSTREAM THROMBUS WAS ABSENT. MURAL THROMBUS BEGAN IN THE ZSLE-13-74 (ZSLE-13-74-ZT) JUST PROXIMAL THE ZSLE-16-90 AND CONTINUED DOWNSTREAM UNTIL JUST PAST AN ACUTE 45 DEGREE BEND OF THE MID ZSLE-16-90. THE ZSLE-16-90'S DIAMETER WAS 12MM X13MM AT THE BEND. THE CONTRALATERAL GATE AND ZSLE-13-74 (ZSLE-13-74-ZT) WERE NOT COMPRESSED OR IMPINGED UPON. IMPRESSIONS OF THE IMAGING REVIEWER REVEALED, ON THE RIGHT NON-OCCLUSIVE MURAL THROMBUS DEVELOPED IN A WIDELY PATENT STRAIGHT SEGMENT THAT WOULD NOT BE EXPECTED TO BE THROMBOGENIC BASED ON TURBULENCE. FURTHERMORE, A STENOSIS CAUSED BY CONSTRAINT OF THE ZSLE-13-74'S (ZSLE-13-74-ZT) SUPERIOR END WHICH SHOULD HAVE BEEN THROMBOGENIC, WAS THROMBUS FREE. THIS SUPPORTS A SYSTEMIC PREDISPOSITION TO THROMBUS FORMATION. THE PATIENT REPORTEDLY WAS NONCOMPLIANT WITH ANTIPLATELET MEDICATION. THE ENTIRE LEFT KIDNEY WAS INFARCTED. ATROPHY INDICATED THAT THE INFARCT WAS NOT ACUTE. THE PATIENT HAD THE INITIAL AAA REPAIR ON 16JAN2014 USING A TFFB MAIN BODY AND FIVE LEG EXTENSIONS. PER THE COOK REPRESENTATIVE, LOOKING AT THE 2018 CTA IT APPEARS THERE IS A 13MM ZSLE SEALING INTO THE FLEX BODY ON EACH SIDE (THAT ARE) USED AS BRIDGING LIMBS. SEALING INTO THE 13MM LEG ON THE RIGHT APPEARS TO BE THE ZSLE-16. TWO ZSLE-24'S ARE ON THE LEFT SIDE WITH ONE TELESCOPING OUT THE OTHER. HUMAN ANATOMY DID PLAY A ROLE IN THIS EVENT. PER THE INSTRUCTIONS FOR USE (IFU) T_ZAAASZ, PRE-EXISTING REGIONS OF STENOSIS/NARROWING (LESS THAN APPROXIMATELY 20MM ID IN THE AORTA OR 7 TO 8 MM ID IN THE ILIACS) HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT. A CHRONIC LEFT RENAL INFARCT WAS NOTED AS WELL. RENAL INFARCTS ARE OFTEN CAUSED BY THROMBOEMBOLI SO, THERE MAY BE A PRE-EXISTING CONDITION OF THROMBUS FORMATION. RENAL INSUFFICIENCY WOULD LIKELY RESULT FROM AN INFARCT WHICH IN TURN COULD RESULT IN INCREASED RISK OF THROMBUS FORMATION. IFU STATES THAT PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE (E.G., CANCER) MAY BE AT AN INCREASED RISK OF THROMBOEMBOLIC EVENT. IT IS ALSO IMPORTANT TO NOTE THE PATIENT HAD NOT BEEN TAKING ANY ANTICOAGULATION MEDICATION, INCLUDING STOPPING THE ASPIRIN. THE PHYSICIAN WAS CONCERNED TO HEAR THIS AND HAS PRESCRIBED A REGIMEN INCLUDING PLAVIX. IT IS ALSO NOT KNOWN IF THE PATIENT FOLLOWED UP BETWEEN 2015 THROUGH 2018. FURTHERMORE, PER THE IMAGING REVIEWER, INCONSISTENT THROMBUS DEVELOPMENT FINDING ON THE RIGHT SIDE SUPPORTS A SYSTEMIC PREDISPOSITION TO THROMBUS FORMATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR THE FINAL ASSEMBLY AND GRAFT SUBASSEMBLY RECORDS REVEALED NO NON-CONFORMANCES. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: 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: ¿ PRE-EXISTING REGIONS OF STENOSIS/NARROWING (LESS THAN APPROXIMATELY 20MM ID IN THE AORTA OR 7 TO 8 MM ID IN THE ILIACS) HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT. ¿ PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE (E.G., CANCER) MAY BE AT AN INCREASED RISK OF THROMBOEMBOLIC EVENT. ¿ ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFE-LONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THE ENDOVASCULAR GRAFT. 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 ¿ GRAFT OR NATIVE VESSEL OCCLUSION THERE IS NO REPRESENTATIVE DEVICE AVAILABLE BECAUSE THERE ARE TOO MANY UNRELATED FACTORS THAT PREVENT A TRUE COMPARISON BETWEEN ONE DEVICE AND ANOTHER. FIRST, THIS DEVICE IS A ONE DEVICE LOT. IN ADDITION, IT IS NOT REASONABLE TO TIE TWO CASES TOGETHER WHERE THERE ARE DIFFERENCES IN PATIENT MEDICAL HISTORY, PATIENT ANATOMY AND PHYSICIAN. FINDINGS OF THE IMAGING REVIEWER: 1). THE COMPLAINT OF LEG OCCLUSION FROM THROMBOSIS IS CONFIRMED. 2). THE LEFT LEG WAS OCCLUDED WITH THROMBUS UP TO AN ACUTE BEND OF THE ZSLE-24-74. THE STENOSIS AND DIRECTION CHANGE WOULD HAVE ENCOURAGED THROMBUS FORMATION. 3). LUMEN CROWDING FROM THE THREE STENT LAYERS OF THE LEFT ILIAC LEG INCREASED THE RISK OF THROMBOSIS. 4). ON THE RIGHT NON-OCCLUSIVE MURAL THROMBUS DEVELOPED IN A WIDELY PATENT STRAIGHT SEGMENT THAT WOULD NOT BE EXPECTED TO BE THROMBOGENIC BASED ON TURBULENCE. FURTHERMORE, A STENOSIS CAUSED BY CONSTRAINT OF THE ZSLE-13-74'S SUPERIOR END WHICH SHOULD HAVE BEEN THROMBOGENIC, WAS THROMBUS FREE. THIS SUPPORTS A SYSTEMIC PREDISPOSITION TO THROMBUS FORMATION. THE PATIENT REPORTEDLY WAS NONCOMPLIANT WITH ANTIPLATELET MEDICATION. 5). THE ENTIRE LEFT KIDNEY WAS INFARCTED. ATROPHY INDICATED THAT THE INFARCT WAS NOT ACUTE. COOK HAS CONCLUDED HUMAN ANATOMY, PATIENT COMPLIANCE AND DISEASE PROGRESSION CONTRIBUTED TO THIS INCIDENT. THIS IS BASED ON IMAGING REVIEW FINDINGS OF STENOSIS, AN ACUTE BEND, PATIENT¿S NON-COMPLIANCE WITH ANTI-COAGULATION THERAPY AND PATIENT¿S RENAL STATUS. 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 IS NO NEW EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LUNDERQUIST WIRE, UNIGLIDE WIRE, PIG TAIL CATHETER, CODA BALLOON, ZSLE-24-90-ZT, TFFB-24-125-ZT, ZSLE-16-90-ZT, ZSLE-13-90-ZT, ZSLE-24-74-ZT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT IS BASED ON INFORMATION DISCOVERED DURING THE INVESTIGATION THAT WAS PERFORMED ON THE EVENT REPORTED IN MANUFACTURER REPORT # 1820334-2018-03267. IMAGING REVIEW PERFORMED DURING THE INVESTIGATION PROCESS INDICATED THAT THERE WAS MURAL THROMBUS THAT BEGAN IN THE ZSLE-13-74 JUST PROXIMAL TO THE ZSLE-16-90 AND CONTINUED DOWNSTREAM UNTIL JUST PAST AN ACUTE 45-DEGREE BEND OF THE MID ZSLE-16-90. THIS REPORT IS FOR THE IDENTIFIED MURAL THROMBUS THAT BEGAN IN THE ZSLE-13-74. MURAL THROMBUS IN THE MID ZSLE-16-90 WILL BE CAPTURED IN MANUFACTURER REPORT # 1820334-2018-03269.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383300 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC G55232 4618971 10827002552323

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR