BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 11120304 · Received January 5, 2021

    Report

    Report Number
    1820334-2021-00019
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    November 10, 2020
    Report Date
    April 19, 2021
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002484181
    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 DR. ERIC FARMER FROM LIVERPOOL HOSPITAL IN AUSTRALIA INFORMED COOK ON (B)(6) 2020 OF AN INCIDENT INVOLVING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, RPN: TFFB-28-96-ZT FROM LOT: 2824523. IT WAS REPORTED THAT THROMBUS FORMATION WAS OBSERVED WITHIN THE DEVICE. THERE WERE NO INTERVENTIONS PERFORMED; HOWEVER, THE PHYSICIAN WAS CONSIDERING RELINING OF THE GRAFT. THE PATIENT UNDERWENT THE ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE ON (B)(6) 2011 TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE FOLLOWING DEVICES: - MAIN BODY: TFFB-28-96-ZT FROM LOT: 2824523. - CONTRALATERAL (RIGHT): ZSLE-13-107-ZT FROM LOT: 2862629. - IPSILATERAL (LEFT): ZSLE-16-90-ZT FROM LOT: 2829556. ADDITIONAL INFORMATION PROVIDED BY THE COOK REPRESENTATIVE STATED THAT THE RADIOLOGY REPORT AT THE USER FACILITY IDENTIFIED THROMBUS FORMATION WITHIN THE GRAFT MAIN BODY, ANEURYSM SAC EXPANSION, A POSTULATED TYPE 3 ENDOLEAK, AND AN ADDITIONAL TYPE 2 ENDOLEAK. ON THE CT PERFORMED ON (B)(6) 2020, THE MAXIMUM AAA DIAMETER MEASURED APPROXIMATELY 65 X 61M. ON THE PREVIOUS STUDY ON (B)(6) 2020, THE MAXIMUM AAA DIAMETER MEASURED APPROXIMATELY 63 X 58MM. THE DEVICES REMAIN IMPLANTED IN THE PATIENT. TWO COMPLAINTS WERE OPENED FOR THE REPORTED EVENT, INCLUDING THE FOLLOWING: - 1820334-2021-00019: THROMBUS FORMATION WITHIN THE TFFB-28-96-ZT GRAFT. - 1820334-2021-00023: TYPE 3 ENDOLEAK ON THE RIGHT LEG GRAFT. REVIEW OF THE IMAGING PROVIDED AND LIST OF REPORTED DEVICES DETERMINED THIS TO BE THE ZSLE-13-107-ZT GRAFT. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE DEVICE, AS WELL AS A REVIEW OF IMAGING PROVIDED BY THE FACILITY AND A DIMENSIONAL VERIFICATION, WAS CONDUCTED DURING THE INVESTIGATION. A SINGLE POSTOPERATIVE CT STUDY DATED (B)(6) 2020 WAS PROVIDED FOR EVALUATION AND REVIEWED BY AN EXPERT IMAGE REVIEWER. A REVIEW OF THE IMAGING PROVIDED CONFIRMED MURAL THROMBUS FORMATION WITHIN THE MAIN BODY GRAFT 9 YEARS POST IMPLANTATION. THE REVIEWER STATED THAT ALTHOUGH AN UNUSUAL AMOUNT OF MURAL THROMBUS ASYMMETRICALLY LINED THE TFFB FROM THE SEALING STENT THROUGH THE AORTIC BIFURCATION, THE THROMBUS WAS SMOOTH AND DID NOT CAUSE STENOSIS RELATIVE TO THE AORTIC CROSS-SECTIONAL AREA AT THE RENAL ARTERIES OR THE ILIAC LEGS. THE SMOOTH THROMBUS REDUCED THE LUMEN DIAMETER TO MATCH THE LUMEN AT THE RENAL ARTERIES AND ILIAC LIMBS. THE REVIEWER DETERMINED THAT THIS TYPE OF THROMBUS IS TYPICALLY STABLE AND INNOCUOUS. SIMILAR MURAL THROMBUS IN THE AORTA PROXIMAL TO THE SUPRARENAL STENT INDICATED A PATIENT SPECIFIC PROPENSITY TOWARDS MURAL THROMBUS ACCUMULATION. PATIENT PRE-EXISTING CONDITIONS WERE REQUESTED BUT NOT PROVIDED FOR THIS INVESTIGATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT SUFFICIENT CONTROLS AND INSPECTIONS ARE IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DESIGN HISTORY FILE (DHF) FOUND THAT THE AFFECTED PRODUCT IS SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 2824523 FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. BECAUSE THERE ARE ADEQUATE INSPECTION ACTIVITIES IN PLACE, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, NO RELATED NON-CONFORMANCES HAVE BEEN RECORDED, AND NO OTHER LOT-RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. IT WAS CONCLUDED THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION RELATED TO THE REPORTED FAILURE MODE: "4 WARNINGS AND PRECAUTIONS 4.1 GENERAL ¿ PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ¿ 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 16 FRENCH TO 22 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. 4.5 IMPLANT PROCEDURE ¿ SYSTEMIC ANTI COAGULATION SHOULD BE USED DURING THE IMPLANTATION PROCEDURE BASED ON HOSPITAL AND PHYSICIAN PREFERRED PROTOCOL. IF HEPARIN IS CONTRAINDICATED, AN ALTERNATIVE ANTICOAGULANT SHOULD BE CONSIDERED. ¿ USE CAUTION DURING MANIPULATION OF CATHETERS, WIRES AND SHEATHS WITHIN AN ANEURYSM. SIGNIFICANT DISTURBANCES MAY DISLODGE FRAGMENTS OF THROMBUS, WHICH CAN CAUSE DISTAL EMBOLIZATION OR RUPTURE OF THE ANEURYSM. 5 ADVERSE EVENTS 5.2 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) ¿ EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA OR INFARCTION ¿ ENDOPROSTHESIS: OCCLUSION ¿ GRAFT OR NATIVE VESSEL OCCLUSION ¿ RENAL COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., ARTERY OCCLUSION, CONTRAST TOXICITY, INSUFFICIENCY, FAILURE) 8 PATIENT COUNSELING INFORMATION ¿ PHYSICIANS MUST ADVISE EACH PATIENT THAT IT IS IMPORTANT TO SEEK PROMPT MEDICAL ATTENTION IF THEY EXPERIENCE SIGNS OF LIMB OCCLUSION, ANEURYSM ENLARGEMENT OR RUPTURE. SIGNS OF GRAFT LIMB OCCLUSION INCLUDE PAIN IN THE HIP(S) OR LEG(S) DURING WALKING OR AT REST OR DISCOLORATION OR COOLNESS OF THE LEG. ANEURYSM RUPTURE MAY BE ASYMPTOMATIC, BUT USUALLY PRESENTS AS: PAIN; NUMBNESS; WEAKNESS IN THE LEGS; ANY BACK, CHEST, ABDOMINAL OR GROIN PAIN; DIZZINESS; FAINTING; RAPID HEARTBEAT OR SUDDEN WEAKNESS. 11 DIRECTIONS FOR USE 11.1 BIFURCATED SYSTEM 11.1.8 CONTRALATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT 3. INTRODUCE THE CONTRALATERAL ILIAC LEG DELIVERY SYSTEM INTO THE ARTERY. ADVANCE SLOWLY UNTIL THE ILIAC LEG GRAFT OVERLAPS AT LEAST ONE FULL ILIAC LEG STENT (I.E., PROXIMAL STENT OF ILIAC LEG GRAFT) INSIDE THE CONTRALATERAL LIMB OF THE MAIN BODY. IF THERE IS ANY TENDENCY FOR THE MAIN BODY GRAFT TO MOVE DURING THIS MANEUVER, HOLD IT IN POSITION BY STABILIZING THE GRAY POSITIONER ON THE IPSILATERAL SIDE. 4. CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE BOTH INTERNAL ILIAC PATENCY AND A MINIMUM OVERLAP OF ONE FULL ILIAC LEG STENT (I.E., PROXIMAL STENT OF ILIAC LEG GRAFT, MAXIMUM OVERLAP OF 1.5 STENTS) WITHIN THE MAIN BODY ENDOVASCULAR GRAFT. 11.1.11 IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT 2. ADVANCE SLOWLY UNTIL THE IPSILATERAL ILIAC LEG GRAFT OVERLAPS A MINIMUM OF ONE FULL ILIAC LEG STENT (I.E., PROXIMAL STENT OF ILIAC LEG GRAFT) INSIDE THE IPSILATERAL LIMB OF THE MAIN BODY. 3. CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE INTERNAL ILIAC PATENCY." BASED ON THE INFORMATION PROVIDED, AN EXPERT REVIEW OF IMAGING PROVIDED, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE CAUSE COULD BE TRACED TO AN ADVERSE EVENT RELATED TO THE PATIENT CONDITION. ENDOLEAKS ARE LISTED AS A POTENTIAL EFFECT IN THE PRODUCT IFU AND ARE A KNOWN INHERENT RISK OF THE DEVICE. 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 ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED THAT THROMBUS FORMATION WAS NOTED WITHIN A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DEVICE, RESULTING IN ANEURYSM SAC EXPANSION. THE RADIOLOGY REPORT NOTED THE ANEURYSM SAC HAD EXPANDED FROM 63X58MM ON (B)(6) 2020 TO 65X61MM ON (B)(6) 2020. THE DEVICE WAS IMPLANTED ALONG WITH 2 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS ON (B)(6) 2011 IN A NOW (B)(6) YEAR-OLD MALE PATIENT. A RELINING OF THE GRAFT IS BEING CONSIDERED BUT HAS NOT YET BEEN SCHEDULED AS THE PHYSICIAN IS STILL CONSIDERING HOW TO PROCEED WITH THIS PATIENT'S TREATMENT. AN ENDOLEAK WAS ALSO REPORTED FOR THIS PATIENT, REPORTED UNDER AN MDR WITH PATIENT IDENTIFIER (B)(6). NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14144 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A 2824523 10827002484181

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR ZSLE-13-107-ZT (LOT # 2862629)| ZSLE-16-90-ZT (LOT # 2829556)