BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6682432 · Received June 30, 2017

    Report

    Report Number
    1820334-2017-01417
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    May 31, 2017
    Report Date
    November 17, 2017
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002552330
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K) P020018. INVESTIGATION- A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL, AND TRENDS WAS CONDUCTED DURING THE INVESTIGATION. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (LOT6976091) WAS NOT RETURNED; THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NON-CONFORMANCES WERE NOTED. A SEARCH OF OUR COMPLAINT RECORDS INDICATED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT LOT NUMBER 6976091. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT THE A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY; DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING AND QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. GRAFT TEARING OR RUPTURE CAN HAPPEN FOR SEVERAL REASONS INCLUDING MANUFACTURING IMPERFECTION, CALCIFICATION WEARING AGAINST THE GRAFT AND EXCESSIVE BALLOONING PRESSURE. DUE TO THE INCIDENCE HAPPENING DURING BALLOON INFLATION, AND THE LACK OF INFORMATION PROVIDED THE CAUSE IS MOST LIKELY DUE TO OVER INFLATION OF THE CODA BALLOON. BASED ON THE AVAILABLE INFORMATION AND THE REVIEW OF THE DOCUMENTATION THE ROOT CAUSE IS LIKELY PRODUCT USE OF HANDLING RELATED ¿ USER TECHNIQUE WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DEVICE IS NOT AVAILABLE FOR EVALUATION. CLINICAL INTERPRETATION OF THE EVENT: BASED ON THE AVAILABLE INFORMATION IT IS REASONABLE TO SUGGEST THAT THE LEADING CAUSE TO THIS EVENT MIGHT BE ASSOCIATED WITH AN EVENTUAL MEDICAL PROCEDURE / INTERVENTION / USER TECHNIQUE INACCURACY OR AN EVENTUAL MALFUNCTION OF THE DEVICE. A DOCUMENT REVIEW WAS PERFORMED AND NO ANOMALIES RELATED TO THE EVENT WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABDOMINAL AORTIC ANEURYSM REPAIR, A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS INSERTED INTO THE PATIENT'S RIGHT COMMON ILIAC. THE DEVICE DEPLOYED SUCCESSFULLY. UPON PUTTING IN THE CODA AND INFLATING THE CODA BALLOON, THE GRAFT RUPTURED IN THE MIDDLE AT THE SPIRAL- Z-STENTS. DUE TO THE RUPTURE, ANOTHER ZSLE WAS IMPLANTED AND SUCCESSFULLY DEPLOYED. THERE WAS NO UNINTENDED SECTION OF THE DEVICE REMAINING INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462638 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA 10827002552330

    Patients

    Seq Age Sex Outcome Treatment
    1 75 DA Required Intervention