BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 5075010 · Received September 14, 2015

    Report

    Report Number
    1820334-2015-00583
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). INVESTIGATION/EVALUATION: DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, QUALITY CONTROL, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND TRENDS OF THE PRODUCT WAS CONDUCTED. THE COMPLAINT PRODUCT WAS NOT RETURNED AND NO PICTURE IMAGES WERE PROVIDED. AN IFU IS PROVIDED THAT STATES THE PROCEDURES OF DEPLOYMENT FOR THE DEVICE IN ORDER TO AVOID ANY EVENTUAL ENDOLEAKS. THE MANUFACTURING RECORDS FOR PRODUCT LOT # 5086667 WERE REVIEWED AND THERE IS NO INDICATION OF ANY ANOMALIES OR DEFICIENCIES. BASED ON THE INFORMATION PROVIDED AND WITHOUT THE RETURNED COMPLAINT DEVICE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT (QERA) NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2015, AN (B)(6) YEAR-OLD MALE PATIENT UNDERWENT AAA REPAIR BY RIGHT APPROACH. THE PATIENT WAS SUITABLE FOR THE PROCEDURE. DEVICES WERE PLACED IN THE FOLLOWING ORDER; A MAIN BODY GRAFT, A GRAFT CONVERTER AND AN ILIAC LEG GRAFT. THE CONVERTER WAS SELECTED BECAUSE VESSEL DIAMETER FROM THE BIFURCATION TO THE LEFT CIA WAS NARROW, (APPROXIMATELY 4MM, AND TORTUOUS). F-F BYPASS WAS PLANNED AFTER THE PROCEDURE. ANGIOGRAPHY CONFIRMED TYPE III ENDOLEAK FROM JUNCTION BETWEEN MAINBODY AND CONVERTER. THEN, AN EXCLUDER EXTENSION DEVICE (ANOTHER MANUFACTURER) WAS ADDITIONALLY PLACED OVERLAPPING THE JUNCTION PART BETWEEN MAINBODY AND CONVERTER. BALLOONING WAS PERFORMED WITH CODA FOR ONE MINUTE IN EACH SITE - PROXIMAL, JUNCTION AND DISTAL. SINCE THE ENDOLEAK STILL REMAINED DESPITE THE ADDITIONAL DEVICE PLACEMENT, A PALMAZ STENT (FROM ANOTHER MANUFACTURER) WAS ADDITIONALLY PLACED. THOUGH THE FLOW DECREASED, THE ENDOLEAK REMAINED. F-F BYPASS WAS PERFORMED AS PLANNED AND THE PROCEDURE WAS FINISHED. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH AND CONDUCT FOLLOW-UP WITH CT WHEN HOSPITAL DISCHARGE. ON (B)(6) 2015, THE PATIENT RECOVERED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, AN (B)(6) MALE PATIENT UNDERWENT AAA REPAIR BY RIGHT APPROACH. THE PATIENT WAS SUITABLE FOR THE PROCEDURE. DEVICES WERE PLACED IN THE FOLLOWING ORDER; A MAIN BODY GRAFT, A GRAFT CONVERTER AND AN ILIAC LEG GRAFT. THE CONVERTER WAS SELECTED BECAUSE VESSEL DIAMETER FROM THE BIFURCATION TO THE LEFT CIA WAS NARROW, (APPROXIMATELY 4MM, AND TORTUOUS). F-F BYPASS WAS PLANNED AFTER THE PROCEDURE. ANGIOGRAPHY CONFIRMED TYPE III ENDOLEAK FROM JUNCTION BETWEEN MAINBODY AND CONVERTER. THEN, EXCLUDER EXTENSION DEVICE (ANOTHER MANUFACTURER) WAS ADDITIONALLY PLACED OVERLAPPING THE JUNCTION PART BETWEEN MAINBODY AND CONVERTER. BALLOONING WAS PERFORMED WITH CODA FOR ONE MINUTE IN EACH SITE - PROXIMAL, JUNCTION AND DISTAL. SINCE THE ENDOLEAK STILL REMAINED DESPITE THE ADDITIONAL DEVICE PLACEMENT, A PALMAZ STENT (FROM ANOTHER MANUFACTURER) WAS ADDITIONALLY PLACED. THOUGH THE FLOW DECREASED, THE ENDOLEAK REMAINED. F-F BYPASS WAS PERFORMED AS PLANNED AND THE PROCEDURE WAS FINISHED. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH AND CONDUCT FOLLOW-UP WITH CT WHEN HOSPITAL DISCHARGE. ON (B)(6) 2015, THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606830 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention