BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8286392 · Received January 29, 2019

    Report

    Report Number
    1820334-2019-00265
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    December 27, 2018
    Report Date
    April 22, 2019
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002552439
    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 RETURNED FOR AN EVALUATION. WITHOUT THE DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. PER FURTHER COMMUNICATION WITH THE USER FACILITY, THE PHYSICIAN HAS CHOSEN NOT TO PROVIDE THE IMAGING; THEREFORE, AN IMAGE REVIEW WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. A REVIEW OF THE DEVICE HISTORY RECORDS FOR WO# 3819572 (ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG), FS3074804 (ZENITH SPIRAL LEG EXTENSION GRAFT), FS2649036 (ZSLE KIT), AND SUPPLIER LOT 1132562.1 WAS PERFORMED; THERE WERE NO NON-CONFORMANCES NOTED. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10MM IN LENGTH AND 7.5-20MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR FOR SIZING REQUIREMENTS AND A LIST OF KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL ANEURYSM EXCLUSION USING A MAIN BODY OR RENU FROM THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS, REFER TO THE APPROPRIATE INSTRUCTIONS FOR USE.4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10MM IN LENGTH AND 7.5-20MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR FOR SIZING REQUIREMENTS AND A LIST OF KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL ANEURYSM EXCLUSION USING A MAIN BODY OR RENU FROM THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS, REFER TO THE APPROPRIATE INSTRUCTIONS FOR USE. 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 17 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. ALL PATIENTS SHOULD BE MONITORED CLOSELY AND CHECKED PERIODICALLY FOR A CHANGE IN THE CONDITION OF THEIR DISEASE AND THE INTEGRITY OF THE ENDOPROSTHESIS AND/OR INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. ALL PATIENTS SHOULD BE MONITORED CLOSELY AND CHECKED PERIODICALLY FOR A CHANGE IN THE CONDITION OF THEIR DISEASE AND THE INTEGRITY OF THE ENDOPROSTHESIS. THE ZENITH SPIRAL-Z AAA ILIAC LEG HAS NOT BEEN EXPLICITLY EVALUATED CLINICALLY; HOWEVER, ITS PERFORMANCE IS REPRESENTED BY THE ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG (A PREVIOUS VERSION OF THE DEVICE), WHICH HAS NOT BEEN EVALUATED IN THE FOLLING PATIENT POPULATIONS: KEY ANATOMICAL ELEMENTS THAT FALL OUTSIDE THE SIZING REQUIREMENTS SPECIFIED IN THE APPROPRIATE MAIN BODY OR RENU INSTRUCTIONS FOR USE SUCCESSFUL PATIENT SELECTION REQUIRES SPECIFIC IMAGING AND ACCURATE MEASUREMENTS; PLEASE SEE SECTION . 4.3 PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING DIAMETERS UTILIZING CT, DIAMETER MEASUREMENTS SHOULD BE DETERMINED FROM THE OUTER WALL TO OUTER WALL VESSEL DIAMETER (NOT LUMEN MEASUREMENT) TO HELP WITH PROPER DEVICE SIZING AND DEVICE SELECTION. 4.4 DEVICE SELECTION STRICT ADHERENCE TO THE ZENITH SPIRAL-Z AAA ILIAC LEG IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE (TABLE 10.5.1). 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. 4.5 IMPLANT PROCEDURE INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. INADEQUATE FIXATION OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT MAY RESULT IN INCREASED RISK OF MIGRATION OF THE STENT GRAFT. INCORRECT DEPLOYMENT OR MIGRATION OF THE ENDORPOSTHESIS MAY REQUIRE SURGICAL INTERVENTION. 11.1.7 MOLDING BALLOON INSERTION 5. EXPAND THE MOLDING BALLOON WITH DILUTED CONTRAST MEDIA (AS DIRECTED BY THE MANUFACTURER) IN THE AREA OF THE MOST PROXIMAL COVERED STENT AND THE INFRARENAL NECK, STARTING PROXIMALLY AND WORKING IN THE DISTAL DIRECTION. (FIG. 15) 6. WITHDRAW THE MOLDING BALLOON TO THE IPSILATERAL LIMB OVERLAP REGION AND EXPAND. 7. WITHDRAW THE MOLDING BALLOON TO THE IPSILATERAL DISTAL FIXATION SITE AND EXPAND. 8. DEFLATE AND REMOVE MOLDING BALLOON. TRANSFER MOLDING BALLOON ONTO THE CONTRALATERAL WIRE GUIDE AND INTO THE CONTRALATERAL ILIAC LEG INTRODUCTION SYSTEM. ADVANCE MOLDING BALLOON TO THE CONTRALATERAL LIMB OVERLAP AND EXPAND. 9. WITHDRAW THE MOLDING BALLOON TO THE CONTRALATERAL ILIAC LEG/VESSEL DISTAL FIXATION SITE AND EXPAND. (FIG. 15) 10. REMOVE MOLDING BALLOON AND REPLACE IT WITH AN ANGIOGRAPHIC CATHETER TO PERFORM COMPLETION ANGIOGRAMS. 12.3 ABDOMINAL RADIOGRAPHS THE FOLLOWING VIEWS ARE REQUIRED: FOUR FILMS: SUPINE-FRONTAL (AP), CROSS-TABLE LATERAL, 30 DEGREE LPO AND 30 DEGREE RPO VIEWS CENTERED ON UMBILICUS. RECORD THE TABLE-TO-FILM DISTANCE AND USE THE SAME DISTANCE AT EACH SUBSEQUENT EXAMINATION ENSURE ENTIRE DEVICE IS CAPTURED ON EACH SINGLE IMAGE FORMAT LENGTHWISE. IF THERE IS ANY CONCERN ABOUT THE DEVICE INTEGRITY (E.G. KINKING, STENT BREAKS, BARB SEPARATION, RELATIVE COMPONENT MIGRATION), IT IS RECOMMENDED TO USE MAGNIFIED VIEWS. THE ATTENDING PHYSICIAN SHOULD EVALUATE FILM FOR DEVICE INTEGRITY (ENTIRE DEVICE LENGTH INCLUDING COMPONENTS) USING 2-3X MAGNIFICATION VISUAL AID. 12.6 ADDITIONAL SURVEILLANCE AND TREATMENT ADDITIONAL SURVEILLANCE AND POSSIBLE TREATMENT IS RECOMMENDED FOR: ANEURYSMS WITH TYPE I ENDOLEAK. ANEURYSMS WITH TYPE III ENDOLEAK. ANEURYSM ENLARGEMENT, =5 MM OF MAXIMUM DIAMETER (REGARDLESS OF ENDOLEAK STATUS) MIGRATION. INADEQUATE SEAL LENGTH. CONSIDERATION FOR REINTERVENTION OR CONVERSION TO OPEN REPAIR SHOULD INCLUDE THE ATTENDING PHYSICIAN¿S ASSESSMENT OF AN INDIVIDUAL PATIENT¿S CO-MORBIDITIES, LIFE EXPECTANCY AND THE PATIENT¿S PERSONAL CHOICES. PATIENTS SHOULD BE COUNSELED THAT SUBSEQUENT REINTERVENTIONS INCLUDING CATHETER BASED AND OPEN SURGICAL CONVERSION ARE POSSIBLE FOLLOWING ENDOGRAFT PLACEMENT. COOK REVIEWED THE DESIGN HISTORY FILE (DHF) FOR THE COMPLAINT DEVICE. DESIGN VERIFICATION TESTING PERFORMED IN THESE TESTS SHOWED THAT THE AFFECTED PRODUCT MEETS THE ESTABLISHED ACCEPTANCE CRITERION FOR MIGRATION, RADIAL FORCE, SUTURE TENSILE STRENGTH, HIGH LOAD/LOW CYCLE LONGITUDINAL FATIGUE, MAXIMUM TENSILE FORCE, AND BENCH DEPLOYMENT. IMAGING, PLANNING AND SIZING SHEET, AND THE PHYSICAL PRODUCT WERE NOT RETURNED FOR EVALUATION. A DEFINITIVE CONCLUSION COULD NOT BE ESTABLISHED AS THERE IS NOT ENOUGH EVIDENCE TO IMPLICATE AND ISOLATE ONE CONTRIBUTING FACTOR OVER ANOTHER. HOWEVER, TAKEN INTO CONSIDERATION THAT THIS ADVERSE EVENT OCCURRED 5 YEARS (2156 DAYS) POST-PROCEDURE AND HAD NO COMPLICATIONS BEFOREHAND AND THAT IT WAS CONFIRMED THE PATIENT HAD MADE REGULAR FOLLOW-UP APPOINTMENTS WITH THE ORIGINAL PHYSICIAN WHO HAD INITIALLY IMPLANTED THE DEVICES, THE MOST LIKELY CONTRIBUTING FACTOR IS DUE TO DISEASE PROGRESSION REGARDING THE PATIENT¿S ANATOMY (ANEURYSMAL EXPANSION) LEADING TO ILIAC DILATION OR INAPPROPRIATE SIZING. A DEFINITIVE CONCLUSION COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THE APPROPRIATE COOK 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 EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TFFB-36-95, LOT 3902292. ZSLE-20-39-ZT, LOT 2793747. 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 THE DEVICES MIGRATED DISTALLY TOGETHER AND CAUSED AN ENDOLEAK THAT LED TO A RUPTURED AORTIC ANEURYSM AT THE LEVEL OF THE INFERIOR MESENTERIC ARTERY (IMA). THE DEVICES WERE ORIGINALLY IMPLANTED AT A DIFFERENT HOSPITAL ON (B)(6) 2013. THE SURGEON COMPLETED AN OPEN JUXTARENAL ANEURYSM REPAIR. THE PATIENT IS CURRENTLY RECOVERING IN THE HOSPITAL. THE PATIENT DID ATTEND FOLLOW UP APPOINTMENTS AS RECENTLY AS (B)(6) 2018 WITH THE PHYSICIAN THAT INITIALLY IMPLANTED THE COMPLAINT DEVICES. THIS REPORT ADDRESSES THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-20-90-ZT, LOT 3819572) THAT MIGRATED DISTALLY. THE FOLLOWING REPORTS ARE RELATED IN REFERENCE AS THE TWO ADDITIONAL DEVICES WERE REPORTED TO MIGRATE DISTALLY AS WELL: 1820334-2019-00264 - TFFB-36-95, LOT 3902292. 1820334-2019-00266 - ZSLE-20-39-ZT, LOT 2793747.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77902 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC G55243 3819572 10827002552439

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention