BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10079686 · Received May 21, 2020

    Report

    Report Number
    1820334-2020-00981
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    December 23, 2019
    Report Date
    November 6, 2020
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: SECTION C CORRECTION: H6- DEVICE CODE INVESTIGATION ¿ EVALUATION THE COMPLAINT FACILITY, (B)(6) HOSPITAL, INFORMED COOK ON (B)(6) 2020 OF AN INCIDENT INVOLVING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-13-56-ZT). IT WAS REPORTED THAT A TYPE THREE ENDOLEAK OCCURRED DURING A PROCEDURE ON 23DEC2020. 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 ADVERSE EFFECTS WERE REPORTED TO THE PATIENT AS A RESULT OF THIS INCIDENT, REVIEWS OF THE DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AND NO IMAGING WAS PROVIDED FOR REVIEW. A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD FOUND THAT PROPER PROCEDURES ARE IN PLACE TO IDENTIFY AND PREVENT THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT THE AFFECTED PRODUCT IS SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED DUE TO A LACK OF LOT INFORMATION FROM THE USER FACILITY. IT SHOULD BE NOTED THAT ZENITH DEVICES ARE ONE-DEVICE LOTS. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. ADDITIONALLY, A REVIEW OF THE PRODUCT LABELING FOR THE DEVICE WAS COMPLETED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING INSTRUCTIONS 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. 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ¿ ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5-20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR. 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 SPIRAL-Z AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE INTERNAL ILIAC ARTERIES. 5.2 POTENTIAL ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ ENDOLEAK 12.1 GENERAL ¿ 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. 12.2 ADDITIONAL SURVEILLANCE AND TREATMENT ADDITIONAL SURVEILLANCE AND POSSIBLE TREATMENT IS RECOMMENDED FOR: ¿ ANEURYSMS WITH TYPE I ENDOLEAK BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF THE PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE FOR THE ENDOLEAK WAS NOT ESTABLISHED. HOWEVER, ENDOLEAKS ARE KNOWN INHERENT RISKS OF THESE DEVICES. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK 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 THE PATIENT/EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ZFEN-P-2-34-122-R, ZFEN-D-12-28-76-C. 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 3 ENDOLEAK WAS FOUND ON IMAGE REVIEW AT THE JUNCTION BETWEEN THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG AND A ZENITH DISTAL FENESTRATED GRAFT'S "SHORT LEG". THE ENDOLEAK WAS FOUND DURING THE INVESTIGATION OF A PREVIOUS COMPLAINT ON THE FENESTRATED GRAFT, REPORTED UNDER MDR# (B)(4). PLEASE NOTE COOK INC DOES NOT MANUFACTURE A FENESTRATED GRAFT. NO ADVERSE EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544649 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 SEE H10