BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 5534123 · Received March 30, 2016

    Report

    Report Number
    3002808486-2016-00154
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    February 22, 2016
    Report Date
    March 8, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K): P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE ABOVE INVESTIGATION IT IS CONCLUDED THAT THE ROOT CAUSE TO THE TYPE III ENDOLEAK WAS MOST LIKELY THE RESULT OF GRAFT MATERIAL PLEATING DUE TO EXCESSIVE OVERSIZING. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS, OR THAT THE IFU WAS NOT SUFFICIENT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: ON (B)(6) 2016, TO TREAT IMPENDING RUPTURE URGENTLY FOR A MALE PATIENT, THE USER USED ZENITH TX2 TAA ENDOVASCULAR GRAFTS. THE RIGHT LEG WAS HIGHLY CALCIFIED BUT HE DECIDED TO INSERT ZENITH TX2 TAA ENDOVASCULAR GRAFTS FROM THE RIGHT BECAUSE IT WAS AN URGENT. THE USER FOUND THE RIGHT LEG VESSEL WAS RUPTURED AFTER USE OF THREE ZENITH TX2 TAA ENDOVASCULAR GRAFTS (ESBE-30-80-T-PF, ZTEG-2PT-40-158-PF AND TBE-40-81-PF) , SO HE PLACED GORE'S EXCLUDER LEG TO TREAT THE RUPTURE ((B)(4)) ON (B)(6) 2016, TYPE III ENDOLEAK FROM SUTURE HOLE WAS CONFIRMED. AS OF (B)(6) 2016, NO ADDITIONAL PROCEDURE HAS PERFORMED FOR THE ENDOLEAK AND THE PATIENT IS CLOSELY FOLLOWED. ((B)(4)) PATIENT OUTCOME: THE PATIENT DIDN'T SHOW ANY PROBLEMATIC SYMPTOMS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: ON (B)(6) 2016, TO TREAT IMPENDING RUPTURE URGENTLY FOR A MALE PATIENT, THE USER USED ZENITH TX2 TAA ENDOVASCULAR GRAFTS. THE RIGHT LEG WAS HIGHLY CALCIFIED BUT HE DECIDED TO INSERT ZENITH TX2 TAA ENDOVASCULAR GRAFTS FROM THE RIGHT BECAUSE IT WAS AN URGENT. THE USER FOUND THE RIGHT LEG VESSEL WAS RUPTURED AFTER USE OF THREE ZENITH TX2 TAA ENDOVASCULAR GRAFTS (ESBE-30-80-T-PF, ZTEG-2PT-40-158-PF AND TBE-40-81-PF) , SO HE PLACED GORE'S EXCLUDER LEG TO TREAT THE RUPTURE ((B)(4)). ON (B)(6) 2016, TYPE III ENDOLEAK FROM SUTURE HOLE WAS CONFIRMED. AS OF 15MAR2016, NO ADDITIONAL PROCEDURE HAVE BEEN PERFORMED FOR THE ENDOLEAK AND THE PATIENT IS CLOSELY FOLLOWED. ((B)(4)). PATIENT OUTCOME: THE PATIENT DIDN'T SHOW ANY PROBLEMATIC SYMPTOMS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191003 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527154

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening