BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 7617953 · Received June 20, 2018

    Report

    Report Number
    3002808486-2018-00710
    Event Type
    Death
    Date Received
    June 20, 2018
    Date of Event
    May 8, 2015
    Report Date
    September 4, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002443256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D4) CATALOG#: ZTEG-2PT-38-202-PF-D G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113 G5) SIMILAR TO DEVICE UNDER 510(K): P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: THE COMPLAINT STATES A PATIENT WHO RECEIVED A ZTEG-2PT-38-202-PF-D DEVICE (PROXIMAL) AND A GZSD-46-123-2 DEVICE (PLACED SECOND) FOR A RUPTURED AORTA ON 14APR2015. THE DEVICES WERE INSERTED FROM THE LEFT GROIN. ON 08MAY2015 AN INFECTION DEVELOPED. ON JUN2015, PSEUDOMONAS WAS IDENTIFIED. CRORYNEBACTERIUM WAS IDENTIFIED IN THE INCISION SITE OF THE LEFT GROIN. ON 4OCT2015 CORYNEBACTERIUM MINUTISSIMUM WAS IDENTIFIED AND ON 01NOV2015 THE PATIENT WAS REPORTED DEAD DUE TO BLOOD POISONING. BASED ON THE LIMITED INFORMATION IT HAS NOT BEEN POSSIBLE TO DETERMINE IF THE IMPLANTED ZTEG STENT GRAFT WAS RESPONSIBLE FOR THE REPORTED INFECTIONS. SEVERAL FACTORS, DURING OR AFTER THE PROCEDURE, COULD POTENTIALLY HAVE CAUSED THE INFECTIONS. BIOLOGICAL TESTING IN COMPLIANCE WITH EN/ISO 10993-1 (2009) HAS BEEN PERFORMED ON THE MATERIALS COMPRISING THE ZENITH TX2 ENDOVASCULAR GRAFT WITH PRO-FORM AND THE Z-TRAK PLUS INTRODUCTION SYSTEM. THE ROOT CAUSE IS UNKNOWN. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE COMPLAINT WAS REOPENED AS TWO PREOPERATIVE CT STUDIES AND 4 POSTOPERATIVE CT STUDIES WERE RECEIVED AND REVIEWED BY AN EXPERT IMAGING REVIEWER. THE COMPLAINT IS CONFIRMED BASED ON THE PROVIDED INFORMATION. THE IMAGING REVIEWER FINDS THAT THE CAUSE OF THE SEPTICEMIA IS MOST LIKELY DUE TO THE LEFT GROIN WOUND INFECTION AND SUSPECTED INFECTED HEMATOMA, AS THE CULTURES POSSIBLY MATCH. THE INFECTION, IN TURN, COULD BE THE CAUSE OF OR WORSENED BY THE SUBSEQUENT ENLARGING HEMATOMA AT 6 MONTHS. THE ROLE OF THE ENDOGRAFT DEVICE AS A POSSIBLE SOURCE OF THE INFECTION CANNOT BE DETERMINED AND THE NEW INFORMATION DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSION OR RISK ASSESSMENT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2015: ZTEG-2PT-38-202-PF-D(MOST PROXIMAL / (B)(4)) AND GZSD-46-123-2(PLACED SECOND/ E3305982) WERE IMPLANTED FOR RUPTURED AORTA OF AN (B)(6) FEMALE PATIENT. OTHER MANUFACTURER'S STENT GRAFT (MAKER AND MODEL UNKNOWN) WAS IMPLANTED IN THE DAMAGED LEFT ILIAC ARTERY. ALL DEVICES WERE INSERTED FROM THE LEFT GROIN. ON (B)(6) 2015: INFECTION WAS DEVELOPED. ON (B)(6) 2015: PSEUDOMONAS CANDIDA WAS IDENTIFIED BY SPUTUM CULTURE. CORYNEBACTERIUM WAS IDENTIFIED IN THE INCISION SITE OF THE LEFT GROIN. ON (B)(6) 2015: CORYNEBACTERIUM MINUTISSIMUM WAS IDENTIFIED BY BLOOD CULTURE. ON (B)(6) 2015: THE PATIENT DECEASED DUE TO BLOOD POISONING. ADDITIONAL INFORMATION PROVIDED ON 12JUN2018: AUTOPSY WAS NOT CONDUCTED. PATIENT OUTCOME: PATIENT IS DECEASED DUE TO BLOOD POISONING.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463575 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3305982 10827002443256

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death