BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5982378 · Received September 28, 2016

    Report

    Report Number
    3002808486-2016-01166
    Event Type
    Injury
    Date Received
    September 28, 2016
    Date of Event
    August 26, 2016
    Report Date
    September 7, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPIRATION DATE: UNKNOWN AS LOT # IS UNKNOWN. SIMILAR TO DEVICE UNDER 510(K) P070016. MFR DATE UNKNOWN AS LOT # IS UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AS NO PRODUCT WAS RETURNED AND NO IMAGING OR PRODUCT LOT # WERE PROVIDED THE INVESTIGATION WAS ONLY BASED ON THE INFORMATION PROVIDED IN THIS COMPLAINT FILE. BECAUSE OF THE VERY LIMITED INFORMATION IT WAS NOT POSSIBLE TO DETERMINE WHETHER IT WAS ACTUALLY A TYPE 3 ENDOLEAK FROM A SUTURE HOLE OR TO DETERMINE THE ROOT CAUSE OF THE ENDOLEAK. AS PER IFU ENDOLEAK IS A KNOWN POTENTIAL ADVERSE EVENT. NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2016: A (B)(6) FEMALE PATIENT PREVIOUSLY HAD TOTAL ARCH REPLACEMENT WITH ELEPHANT TRUNK UNDERWENT TAA REPAIR. ZTEG-2P-30-140-JP WAS PLACED AND GORE'S C-TAG 34-34-200 WERE PLACED DISTALLY TO ZTEG. ON (B)(6) 2016: AT A FOLLOW-UP, GROWTH OF THE ANEURYSM (+6MM) WAS CONFIRMED BY NON-CONTRAST X-RAY CT IMAGE. ON (B)(6) 2016: DUE TO CONFIRMATION OF ANEURYSM GROWTH, CONTRAST ENHANCED CT WAS PERFORMED AND TYPE IB AND TYPE II ENDOLEAKS WERE CONFIRMED. ON (B)(6) 2016: TWO GORE CUFF (36MM) WERE ADDITIONALLY PLACED TO TREAT TYPE IB ENDOLEAK. ON (B)(6) 2016: TYPE IB WAS SOLVED. TYPE II WAS STILL CONFIRMED AND WAIT-AND-SEE APPROACH WAS TAKEN. ON (B)(6) 2016: GROWTH OF ANEURYSM WAS CONFIRMED. (F72MM). ON (B)(6) 2016: CONTRAST ENHANCED CT WAS PERFORMED, AND THEN 4D CT WAS CREATED. THE PHYSICIAN CONFIRMED THERE WAS TYPE III ENDOLEAK FROM SUTURE HOLE BY 4D CT IMAGES. ADDITIONAL PROCEDURE TO TREAT THE ENDOLEAK WILL BE PERFORMED BUT THE DATE IS NOT FIXED YET. PATIENT OUTCOME: THE PATIENT'S CONDITION IS UNKNOWN AS NOT PROVIDED BY THE REPORTER.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(6) 2016: A (B)(6) FEMALE PATIENT PREVIOUSLY HAD TOTAL ARCH REPLACEMENT WITH ELEPHANT TRUNK UNDERWENT TAA REPAIR. ZTEG-2P-30-140-JP WAS PLACED AND GORE'S C-TAG 34-34-200 WERE PLACED DISTALLY TO ZTEG. (B)(6) 2016: AT A FOLLOW-UP, GROWTH OF THE ANEURYSM (+6MM) WAS CONFIRMED BY NON-CONTRAST X-RAY CT IMAGE. (B)(6) 2016: DUE TO CONFIRMATION OF ANEURYSM GROWTH, CONTRAST ENHANCED CT WAS PERFORMED AND TYPE IB AND TYPE II ENDOLEAKS WERE CONFIRMED. (B)(6) 2016: TWO GORE CUFF (36MM) WERE ADDITIONALLY PLACED TO TREAT TYPE IB ENDOLEAK. (B)(6) 2016: TYPE IB WAS SOLVED. TYPE II WAS STILL CONFIRMED AND WAIT-AND-SEE APPROACH WAS TAKEN. (B)(6) 2016: GROWTH OF ANEURYSM WAS CONFIRMED. (F72MM). (B)(6) 2016: CONTRAST ENHANCED CT WAS PERFORMED, AND THEN 4D CT WAS CREATED. THE PHYSICIAN CONFIRMED THERE WAS TYPE III ENDOLEAK FROM SUTURE HOLE BY 4D CT IMAGES. ADDITIONAL PROCEDURE TO TREAT THE ENDOLEAK WILL BE PERFORMED BUT THE DATE IS NOT FIXED YET. PATIENT OUTCOME: THE PATIENT'S CONDITION IS UNKNOWN AS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634011 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening