BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7260752 · Received February 9, 2018

    Report

    Report Number
    1820334-2018-00379
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    September 28, 2017
    Report Date
    March 16, 2018
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY INVESTIGATION: THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. IMAGING WAS PROVIDED FOR REVIEW. A DOCUMENTATION BASED INVESTIGATION WAS PERFORMED. A REVIEW OF IMAGING, COMPLAINT HISTORY, THE DEVICE HISTORY RECORDS, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL DATA WAS CONDUCTED. THE IMAGE REVIEW CONFIRMED 3MM OF ABNORMAL LEFT ZSLE SEAL ZONE THICKENING WAS CONSISTENT WITH MURAL THROMBUS. ALTHOUGH A TYPE IB ENDOLEAK ACROSS THE MURAL THROMBUS WAS NOT OBSERVED TYPE II ENHANCEMENT OF THE ADJACENT ANEURYSM SAC ON DELAYED PHASE RAISES THE POSSIBILITY OF A TYPE IB ENDOLEAK UNDETECTABLE WITH CTA. BASED ON THIS INFORMATION, THE THROMBUS IS MOST LIKELY BETWEEN THE VESSEL AND THE GRAFT IN THE LEFT ZSLE SEAL ZONE WHICH INCREASES RISK FOR THE PATIENT TO DEVELOPE A TYPE IB ENDOLEAK AT THIS SITE. THERE WAS NO INDICATION OF IMPROPER OVERLAP, EXTERNAL COMPRESSION, IMPROPER SIZING, OR NARROWED LUMEN IN THE DEVICE. THE MOST LIKELY CAUSES OF THIS THROMBUS FORMATION INCLUDES GENETIC PREDISPOSITION, PATIENT ANATOMY AND DISEASE PROGRESSION. AFTER FURTHER CLARIFICATION, THE RPN OF THE LEFT ZSLE WAS CONFIRMED TO BE ZSLE-24-74-ZT AND THE LOT NUMBER WAS EITHER 5183585 OR 5183586. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR BOTH ZSLE-24-74-ZT LOT NUMBERS GIVEN (5183585 OR 5183586) AS WELL AS THEIR RESPECTIVE ZSLEG-24-74 GRAFT LOT NUMBERS (FS4530015 AND FS4517047) AND NO NON-CONFORMANCES WERE DOCUMENTED. A REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS HAVE BEEN RECEIVED THAT ARE ASSOCIATED WITH EITHER OF THE TWO LOTS (5183585 OR 5183586). THROMBOSIS CAN OCCUR FOR A VARIETY OF REASONS, SUCH AS GENETIC PREDISPOSITION, ILIAC TORTUOSITY, EXTERNAL COMPRESSION, PULSATION, STENOSIS, IMPROPER OVERLAP, NARROW INNER ILIAC LUMEN, VESSEL DAMAGE, AND ROUGH SURFACES. TORTUOSITY, COMPRESSION, AND PULSATION CAN CREATE HIGH SHEAR FORCES WITHIN THE LEG THAT STIMULATE THROMBUS GROWTH. WHERE A SMALL THROMBUS HAS FORMED, THE CLOT CAN ENLARGE BECAUSE THE BLOOD FLOW SLOWS AROUND THE CLOT, ALLOWING CLOT-FORMING ELEMENTS TO BE DEPOSITED. PULSATION AND A SMALL INNER LUMEN CAN OCCUR THROUGH GRAFT OVERSIZING OR UNDER-SIZING. EACH DEVICE IS SHIPPED WITH THE INSTRUCTIONS FOR USE (IFU) THAT LISTS THE ANATOMICAL REQUIREMENTS, WARNING & PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU ALSO ADVISES ON APPROPRIATE PATIENT FOLLOW UP SO THAT CHANGES IN THE STRUCTURE, SHOULD THEY OCCUR, CAN BE IDENTIFIED AND ADDRESSED BEFORE CAUSING CLINICAL PROBLEMS. THIS SHOULD YIELD A VERY HIGH PROBABILITY OF DETECTION. IT IS IMPORTANT TO NOTE THAT BECAUSE THE IMAGE REVIEW INDICATES THAT THIS THROMBUS FORMATION IS IN THE DISTAL SEAL ZONE OF THE ZSLE, THE PATIENT IS AT AN INCREASED RISK TO DEVELOP A TYPE IB ENDOLEAK, AS THE THROMBOSIS IS MOST LIKELY BETWEEN THE GRAFT AND THE VESSEL. THEREFORE, THE FAILURE MODE FOR THIS COMPLAINT IS OCCLUDED VESSEL. THERE WERE NO REPORTED ADVERSE EVENTS OR SECONDARY PROCEDURES FOR THIS OCCURRENCE. THIS COMPLAINT WAS CONFIRMED BASED ON IMAGE REVIEW. A DEFINITIVE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THE APPROPRIATE COOK PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (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

    THIS REPORT IS RELATED TO MANUFACTURER REPORT # 1820334-2017-03490. DURING THE IMAGING REVIEW PERFORMED FOR THE AFOREMENTIONED CASE, IT WAS OBSERVED THAT 3MM OF ABNORMAL SEAL ZONE THICKENING CONSISTENT WITH MURAL THROMBUS WAS IN THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THIS REPORT HAS BEEN CREATED TO CAPTURE THE IDENTIFIED ISSUE OF MURAL THROMBUS. THERE HAVE BEEN NO KNOWN ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. NO ADDITIONAL PROCEDURES HAVE BEEN REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103860 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR