BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8692272 · Received June 12, 2019

    Report

    Report Number
    1820334-2019-01409
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    April 8, 2019
    Report Date
    August 2, 2019
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002552422
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATION OF THE DEVICE COULD BE COMPLETED. HOWEVER, IMAGING WAS PROVIDED FOR THE INVESTIGATION. FINDINGS OF THE EXPERT IMAGE REVIEW INCLUDE: RIGHT ZSLE THROMBOSIS, ZALB MURAL THROMBUS, AND LEFT ZSLE MURAL THROMBUS IS CONFIRMED. NO ANATOMIC EXPLANATION OR RISK FACTOR IS CONFIRMED. THE RIGHT ZSLE STEP-OFF COULD INDUCE THROMBUS FORMATION FROM INCREASED TURBULENCE ALTHOUGH THIS IS A COMMON ASYMPTOMATIC CONFIGURATION. THE PRESENCE OF THROMBUS IN THE MAIN BODY AND THE LEFT ZSLE IS UNUSUAL AND SUGGESTS A PRO-THROMBOTIC TENDENCY TOWARDS THE ENDOGRAFT. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. DESIGN VERIFICATION TESTING SHOWED THAT THE AFFECTED PRODUCT IS SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 7071424 FOUND ZERO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS, OR THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO 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.¿ 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. 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. STRICT ADHERENCE TO THE ZENITH SPIRAL-Z AAA ILIAC LEG IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE. APPROPRIATE DEVICE OVERSIZING HAS BEEN INCORPORATED INTO THE IFU SIZING GUIDE. SIZING OUTSIDE OF THIS RANGE CAN RESULT IN ENDOLEAK, FRACTURE, MIGRATION, DEVICE INFOLDING OR COMPRESSION.¿ ¿INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH SPIRAL-Z AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. POTENTIAL ADVERSE EVENTS: ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDOANEURYSM. GRAFT OR NATIVE VESSEL OCCLUSION. INSTRUCTIONS FOR USE: 11.1.6.4. ¿INTRODUCE THE IPSILATERAL ILIAC LEG DELIVERY SYSTEM, AND CONTINUE ADVANCING SLOWLY UNTIL THE PROXIMAL EDGE OF THE IPSILATERAL LEG GRAFT ALIGNS WITH THE PROXIMAL EDGE OF THE PREVIOUSLY-PLACED CONTRALATERAL LEG GRAFT. WE HAVE NO PAST MEDICAL HISTORY THAT COULD SHED LIGHT ON ANY PATIENT PREDISPOSITION TO THROMBUS FORMATION. WE ARE NOT AWARE OF PATIENT MOBILITY, WEIGHT OR INHERITED DISORDERS THAT MAY HAVE CONTRIBUTED TO THROMBUS FORMATION. THERE IS NO INFORMATION REGARDING HANDLING OF THE DEVICE. THERE IS NO INFORMATION SURROUNDING THE PROCEDURE OR ANY PROCEDURAL DIFFICULTIES. THERE ARE NO PLANNING AND SIZING SHEETS FOR REVIEW. IT SHOULD BE NOTED THE PATIENT WAS ONLY ON ASPIRIN POST PROCEDURE AND THERE¿S NO MENTION OF ITS EFFECTIVENESS FOR THIS PATIENT. ALSO, PATIENTS WHO HAVE RECENT SURGERY ARE ALSO AT RISK FOR THROMBUS FORMATION. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE TRACED TO THE DEVICE, BUT RATHER TO AN ADVERSE EVENT RELATED TO THE PATIENT CONDITION. IT SHOULD BE NOTED THAT THROMBUS FORMATION IS A KNOWN INHERENT RISK OF THE DEVICE. THIS IS EVIDENT IN THE IMAGING REVIEWER'S SUGGESTION THAT THE PATIENT MAY HAVE A "PRO-THROMBOTIC TENDENCY TOWARDS THE ENDOGRAFT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ZIMB-30-118 (LOT NUMBER 7098169), ZSLE-16-74-ZT (LOT NUMBER 6305907), LUNDERQUIST WIRES, CODA BALLOON, GLIDE WIRES, PROGLIDES, ZSLE-20-74-ZT (LOT. 7071424). (B)(6). 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

    DURING THE INVESTIGATION FOR AN EVENT REGARDING A PATIENT WITH AN OCCLUDED RIGHT LEG AND THROMBUS EXTENDING INTO THE RIGHT SIDE OF THE BODY, IT WAS FOUND THAT THROMBUS WAS ALSO PRESENT IN THE LEFT LEG. RIGHT LEG OCCLUSION AND THROMBUS WAS PREVIOUSLY REPORTED IN MFG REPORT # 1820334-2019-00521.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483571 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A 7071424 10827002552422

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR