BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10803646 · Received November 6, 2020

    Report

    Report Number
    1820334-2020-02033
    Event Type
    Injury
    Date Received
    November 6, 2020
    Report Date
    October 14, 2021
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. (B)(6) HOSPITAL INFORMED COOK OF AN INCIDENT INVOLVING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (UNKNOWN ZSLE) FROM AN UNKNOWN LOT. IT WAS NOTED THAT THE GRAFT WAS OCCLUDED DURING A FOLLOW-UP. ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION FROM THE USER FACILITY WERE EXECUTED; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED TO COOK IN RESPONSE TO THIS INCIDENT. NO ADDITIONAL HARM WAS REPORTED. A REVIEW OF THE COMPLAINT HISTORY, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED 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) SHOWED THAT THIS DEVICE IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION FROM THE USER FACILITY. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_ZAAASZ_REV4] ¿ZENITH SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRACK INTRODUCTION SYSTEM,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER 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 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 ILIACS) 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. ADDITIONALLY, THE COMPLETION ANGIOGRAM (WITH STIFF WIRE GUIDES REMOVED) SHOULD BE REVIEWED CAREFULLY TO DETERMINE IF FURTHER TREATMENT IN THESE REGIONS IS NECESSARY (E.G., ADJUNCTIVE BALLOONING OR STENTING). FAILURE TO REMOVE THE STIFF WIRE GUIDE PRIOR TO THE ANGIOGRAM COULD MASK ANY LIMB KINKING OR NARROWING THAT MIGHT OCCUR WHEN THE WIRE GUIDE IS REMOVED. ¿ FOLLOW-UP IMAGING SHOULD BE CAREFULLY REVIEWED FOR NARROWING WITHIN THE GRAFT LEG. PATIENTS 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. ¿ PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE (E.G., CANCER) MAY BE AT AN INCREASED RISK OF A THROMBOEMBOLIC EVENT. 4.5 IMPLANT PROCEDURE ¿ SYSTEMIC ANTICOAGULATION SHOULD BE USED DURING THE IMPLANT 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 MAY RUPTURE THE ANEURYSM. ¿ EXCESSIVE OVERLAP 10 MM ABOVE THE MAIN BODY BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS. 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) 11 DIRECTIONS FOR USE 11.1 ZENITH SPIRAL-Z AAA ILIAC LEG SYSTEM 11.1.4 CONTRALATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT 3. INTRODUCE THE CONTRALATERAL ILIAC LEG DELIVERY SYSTEM INTO THE ARTERY. ADVANCE SLOWLY UNTIL AT LEAST ONE STENT OF THE ILIAC LEG GRAFT OVERLAPS WITHIN THE MAIN BODY AND NOT PAST THE RADIOPAQUE MARKER BAND POSITIONED 30 MM FROM THE PROXIMAL END OF THE ILIAC LEG GRAFT INSIDE THE CONTRALATERAL LIMB OF THE MAIN BODY. 4. CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE INTERNAL ILIAC PATENCY, A MINIMUM OVERLAP OF ONE STENT, AND A MAXIMUM OVERLAP OF 30 MM WITHIN THE MAIN BODY ENDOVASCULAR GRAFT. 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. 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, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT WAS UNABLE TO BE ESTABLISHED. HOWEVER, IT SHOULD BE NOTED THAT THROMBUS FORMATION IS A KNOWN INHERENT RISK OF USING THIS DEVICE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE INFORMATION: EXACT RPN OF COMPLAINT DEVICE IS UNKNOWN BUT THE ZENITH LEGS IMPLANTED INTO THE PATIENT WERE: G55237, RPN ZSLE-16-56-ZT, LOT 5120159, G55238, RPN ZSLE-16-74-ZT, LOT 5127074. INITIAL REPORTER CUSTOMER (PERSON): (B)(6). (B)(4). 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 A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG OCCLUDED WHILE IMPLANTED IN A PATIENT. A MALE PATIENT HAD ONE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY AND TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS IMPLANTED ON (B)(6) 2014 DURING A STANDARD INFRARENAL AAA REPAIR PROCEDURE. IT WAS LATER REPORTED THAT ONE OF THE LIMBS HAS OCCLUDED. A THROMBECTOMY AND RECANNULATION PROCEDURE WAS PERFORMED ON (B)(6) 2020 TO RESTORE BLOOD FLOW. THE PHYSICIAN ALSO MENTIONED DIFFICULTY CANNULATING THE LIMB THE DAY BEFORE. ANOTHER INTERVENTION MAY OCCUR TO RELINE THE LIMBS BUT NO DATE OR PLAN FOR THIS PROCEDURE HAS BEEN REPORTED AT THIS TIME. NO ADDITIONAL INFORMATION REGARDING THIS CASE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265095 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention G49678, RPN ZALB-30-118, LOT 462642| G49678, RPN ZALB-30-118, LOT 462642