BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6338560 · Received February 17, 2017

    Report

    Report Number
    3002808486-2017-00512
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    December 26, 2015
    Report Date
    December 26, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE ABOVE, IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THIS EVENT. THE MOST LIKELY CAUSE CAN BE RELATED TO THE ACTIVATION OF THE HYDROPHILIC COATING DURING PREPARATION. ACCORDING TO THE PACKAGE INSERT, BOTH THE SHEATH AND THE DIALITOR TIP MUST BE ACTIVATED IN ORDER TO ENHANCE TRACKABILITY IN THE ILIAC ARTERIES AND THORACIC AORTA. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016 (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE ABOVE, IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THIS EVENT. THE MOST LIKELY CAUSE CAN BE RELATED TO THE ACTIVATION OF THE HYDROPHILIC COATING DURING PREPARATION. ACCORDING TO THE PACKAGE INSERT, BOTH THE SHEATH AND THE DIALITOR TIP MUST BE ACTIVATED IN ORDER TO ENHANCE TRACKABILITY IN THE ILIAC ARTERIES AND THORACIC AORTA. NO EVIDENCE TO SUGGEST THAT THIS DEVICE 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: A (B)(6) YEAR OLD MALE PATIENT UNDERWENT TAA REPAIR. THE PATIENT'S ABDOMINAL AORTA HAD BEEN REPLACED WITH ARTIFICIAL VESSEL AND THE ANASTOMOSIS SITE IN THE COMMON ILIAC ARTERY WAS SLIGHTLY STENOSED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM FROM THE RIGHT FEMORAL, BUT THE DELIVERY SYSTEM WOULD NOT PASS THE ANASTOMOSIS SITE IN THE COMMON ILIAC ARTERY WHICH WAS MEASURED AS 9MM BY IVUS PREVIOUSLY. THE PHYSICIAN MANAGED TO PASS GORE'S 24FR DRYSEAL SHEATH THROUGH THE ANASTOMOSIS SITE AND PLACED GORE'S C-TAG(40MM X 200MM) INSTEAD AND COMPLETED THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121835 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526997

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR