BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11123511 · Received January 6, 2021

    Report

    Report Number
    1820334-2021-00023
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    November 10, 2020
    Report Date
    April 19, 2021
    Manufacturer
    COOK INC
    Product Code
    MIH
    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. ADDITIONAL INFORMATION: D- PRODUCT IDENTIFIER, D4- PRODUCT LOT # (MDR), D4- PRODUCT LOT #, D4- RPN, D4- EXPIRATION DATE, D4- UDI, D8, H4. INVESTIGATION ¿ EVALUATION: DR. (B)(6) FROM (B)(6) HOSPITAL IN AUSTRALIA INFORMED COOK ON (B)(6) 2020 OF AN INCIDENT INVOLVING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-13-107-ZT FROM LOT: 2862629. IT WAS REPORTED THAT A TYPE 3 ENDOLEAK WAS OBSERVED ADJACENT TO THE RIGHT LIMB OF THE STENT. 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)V2011 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) 020, THE MAXIMUM AAA DIAMETER MEASURED APPROXIMATELY 65 X 61M. ON THE PREVIOUS STUDY ON 18MAR2020, THE MAXIMUM AAA DIAMETER MEASURED APPROXIMATELY 63 X 58MM. 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. THE COMPLAINT DEVICES ARE STILL IMPLANTED WITHIN THE PATIENT. 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 OF THE DEVICE PROVIDED BY THE FACILITY, WAS CONDUCTED DURING THE INVESTIGATION. A SINGLE POSTOPERATIVE CT STUDY DATED 10NOV2020 WAS PROVIDED FOR EVALUATION AND REVIEWED BY AN EXPERT IMAGE REVIEWER. A REVIEW OF THE IMAGING PROVIDED CONFIRMED AN ENDOLEAK IN THE POSTERIOR ANEURYSM SAC JUST PROXIMAL TO THE AORTIC BIFURCATION OBSERVED ON DELAYED PHASE IMAGING. THE REVIEWER STATED THAT THE ENDOLEAK'S APPEARANCE ONLY ON THE DELAYED PHASE CT WOULD SUGGEST A TYPE 2 RATHER THAN A TYPE 3 ENDOLEAK. THE ENDOLEAKS CLASSIFICATION WAS LIMITED DUE TO THE LARGE AMOUNT OF EMBOLIC MATERIAL PLACED AS A SECONDARY INTERVENTION FOR THE TYPE 2 ENDOLEAK. ALTHOUGH THE TYPE 3B ENDOLEAK WAS NOT CLEARLY IDENTIFIED ON THE IMAGING PROVIDED, POSSIBLE CONTRIBUTING FACTORS COULD BE RELATED TO CALCIFIED PLAQUE INVOLVING APPROXIMATELY 25% OF THE AORTIC WALL JUST SUPERIOR TO THE AORTIC BIFURCATION, A NARROW LUMEN AT THE AORTIC BIFURCATION (18MM X 25.4MM) AND PROLONGED FRICTIONAL/PULSATILE FORCES ON THE GRAFT THROUGH THE 9 YEAR POSTOPERATIVE INTERVAL. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THE FAILURE MODE PRIOR TO DISTRIBUTION. 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 2862629 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. THE ZSLE-13-107-ZT IS A ONE-DEVICE LOT, GIVING NO INDICATION OF NON-CONFORMING PRODUCT IN HOUSE. BECAUSE THERE ARE NO RELATED NONCONFORMANCES, THERE ARE ADEQUATE INSPECTION ACTIVITIES IN PLACE, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, 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 ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING ENLARGING ANEURYSMS, UNACCEPTABLE DECREASE IN FIXATION LENGTH (VESSEL AND COMPONENT OVERLAP) AND/OR ENDOLEAK. AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK OR MIGRATION MAY LEAD TO ANEURYSM RUPTURE. 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 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 PATIENT MAY PRECLUDE PLACEMENT OF AN ENDOVASCULAR GRAFT. 4.3 PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING ¿ AFTER ENDOVASCULAR GRAFT PLACEMENT, PATIENTS SHOULD BE REGULARLY MONITORED FOR PERIGRAFT FLOW, ANEURYSM GROWTH OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT. AT A MINIMUM, ANNUAL IMAGING IS REQUIRED, INCLUDING: 1) ABDOMINAL RADIOGRAPHS TO EXAMINE DEVICE INTEGRITY (SEPARATION BETWEEN COMPONENTS OR STENT FRACTURE) AND 2) CONTRAST AND NON-CONTRAST CT TO EXAMINE ANEURYSM CHANGES, PERIGRAFT FLOW, PATENCY, TORTUOSITY AND PROGRESSIVE DISEASE. 5.2 POTENTIAL ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: - ENDOLEAK - ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT, INCOMPLETE COMPONENT DEPLOYMENT; COMPONENT MIGRATION; COMPONENT SEPARATION FROM ANOTHER GRAFT COMPONENT; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; AND CORROSION 11 DIRECTIONS FOR USE PRE-IMPLANT DETERMINANTS 6. DEGREE OF VASCULAR CALCIFICATION. 11.1 ZENITH SPIRAL-Z AAA ILIAC LEG SYSTEM 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. 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. FINAL ANGIOGRAM 1. POSITION ANGIOGRAPHIC CATHETER JUST ABOVE THE LEVEL OF THE RENAL ARTERIES. PERFORM ANGIOGRAPHY TO VERIFY THAT THE RENAL ARTERIES ARE PATENT AND THAT THERE ARE NO ENDOLEAKS. VERIFY PATENCY OF INTERNAL ILIAC ARTERIES. 2. CONFIRM THERE ARE NO ENDOLEAKS OR KINKS AND VERIFY POSITION OF PROXIMAL GOLD RADIOPAQUE MARKERS. REMOVE THE SHEATHS, WIRES AND CATHETERS. NOTE: IF ENDOLEAKS OR OTHER PROBLEMS ARE OBSERVED, REFER TO THE SUGGESTED INSTRUCTIONS FOR USE FOR THE ZENITH AAA ENDOVASCULAR GRAFT ANCILLARY COMPONENTS. 12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP 12.1 GENERAL THE LONG-TERM PERFORMANCE OF ENDOVASCULAR GRAFTS WITH SECONDARY ENDOVASCULAR INTERVENTION USING ADDITIONAL COMPONENTS HAS NOT YET BEEN ESTABLISHED. ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFELONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ADDITIONAL FOLLOW-UP." BASED ON THE INFORMATION PROVIDED, AN EXPERT REVIEW OF IMAGING PROVIDED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE ENDOLEAK COULD NOT BE DETERMINED. ENDOLEAKS AND THROMBUS FORMATION ARE LISTED AS POTENTIAL EFFECTS IN THE PRODUCT IFU AND ARE A KNOWN INHERENT RISKS 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

    LOT #: EXACT RPN OF COMPLAINT DEVICE IS UNKNOWN BUT THE ZENITH LEGS IMPLANTED INTO THE PATIENT WERE: ZSLE-13-107-ZT (LOT # 2862629) AND ZSLE-16-90-ZT (LOT # 2829556). (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 A TYPE III ENDOLEAK WAS NOTED WITHIN A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE TYPE III ANTERIOR ENDOLEAK WAS SEEN WITHIN THE INFERIOR ASPECT OF THE ANEURYSM SAC ADJACENT TO THE RIGHT LIMB OF THE STENT, AND OBSERVED IN A RADIOLOGY REPORT FROM (B)(6) 2020. THE DEVICE WAS IMPLANTED ALONG WITH ANOTHER ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG AND A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY ON 19(B)(6) DEC 2011 IN A NOW (B)(6) YEAR-OLD MALE PATIENT. THROMBUS FORMATION IN THE MAIN BODY 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
    22950 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC 2862629

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR TFFB-28-96-ZT (LOT # 2824523)