BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6375592 · Received March 3, 2017

    Report

    Report Number
    3002808486-2017-00715
    Event Type
    Injury
    Date Received
    March 3, 2017
    Date of Event
    January 8, 2016
    Report Date
    February 24, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527062
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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). MANUFACTURER REF# (B)(4). A1) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A4) UNKNOWN AS INFORMATION WAS NOT PROVIDED. 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. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AS NO IMAGING WAS PROVIDED IT WAS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED EVENT. IT IS NOTED THAT THE DIAMETER OF THORACIC AND ABDOMAL TRUE LUMEN ARE INCREASED OVER TIME AND THAT THE DIAMETER OF THORACIC FALSE LUMEN AND OVERALL ABDOMINAL FALSE LUMEN ARE DECREASED OVER TIME. APPARENTLY, THE PROXIMAL TYPE I ENTRY FLOW DISAPPEARED AT 4 DAYS POST PROCEDURE FOLLOW-UP CT ANGIO. AS PER IFU ENDOLEAK IS A KNOWN POTENTIAL ADVERSE EFFECT. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. 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 STUDY: ON (B)(6) 2016: ZTEG-2PT-34-157-PF, GZSD-36-123-2 AND GZSD-36-164-2 WERE PLACED IN A (B)(6) YEAR OLD MALE PATIENT AND PROXIMAL TYPE I ENTRY FLOW WAS CONFIRMED AT THE FINAL CONFIRMATORY ANGIOGRAPHY. ON (B)(6) 2016: AT A FOLLOW-UP EXAM, THE PHYSICIAN CONFIRMED THAT THE FALSE LUMEN WAS PARTIALLY THROMBOSED. THERE WAS A FLOW FROM A RE-ENTRY AT A LEVEL OF THE CELIAC ARTERY BUT THE PROXIMAL TYPE I ENTRY FLOW WAS GONE. ADDITIONAL INFORMATION RECEIVED 08MAR2017: THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE. NO ADDITIONAL PROCEDURE WAS PERFORMED FOR PROXIMAL TYPE I ENTRY FLOW. PATIENT OUTCOME: NO PROBLEMATIC SYMPTOMS HAVE BEEN OBSERVED.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P140016. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K): P070016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2016: ZTEG-2PT-34-157-PF, GZSD-36-123-2 AND GZSD-36-164-2 WERE PLACED IN A (B)(6) MALE PATIENT AND PROXIMAL TYPE I ENTRY FLOW WAS CONFIRMED AT THE FINAL CONFIRMATORY ANGIOGRAPHY. ON (B)(6) 016: AT A FOLLOW-UP EXAM, THE PHYSICIAN CONFIRMED THAT THE FALSE LUMEN WAS PARTIALLY THROMBOSED. THERE WAS A FLOW FROM A RE-ENTRY AT A LEVEL OF THE CELIAC ARTERY BUT THE PROXIMAL TYPE I ENTRY FLOW WAS GONE. PATIENT OUTCOME: NO PROBLEMATIC SYMPTOMS HAVE BEEN OBSERVED.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: (B)(6) 2016: ZTEG-2PT-34-157-PF, GZSD-36-123-2 AND GZSD-36-164-2 WERE PLACED IN A (B)(6) MALE PATIENT AND PROXIMAL TYPE I ENTRY FLOW WAS CONFIRMED AT THE FINAL CONFIRMATORY ANGIOGRAPHY. ON (B)(6) 2016: AT A FOLLOW-UP EXAM, THE PHYSICIAN CONFIRMED THAT THE FALSE LUMEN WAS PARTIALLY THROMBOSED. THERE WAS A FLOW FROM A RE-ENTRY AT A LEVEL OF THE CELIAC ARTERY BUT THE PROXIMAL TYPE I ENTRY FLOW WAS GONE. ADDITIONAL INFORMATION RECEIVED 08MAR2017: THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE. NO ADDITIONAL PROCEDURE WAS PERFORMED FOR PROXIMAL TYPE I ENTRY FLOW. PATIENT OUTCOME: NO PROBLEMATIC SYMPTOMS HAVE BEEN OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159657 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527062

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening