BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ®TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5976283 · Received September 26, 2016

    Report

    Report Number
    3002808486-2016-01150
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    February 15, 2016
    Report Date
    March 8, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    PMA / PMN Number
    P140016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE PROVIDED INFORMATION AND THE IMAGING, IT WAS POSSIBLE TO DETERMINE THE EXISTENCE OF THE REPORTED MURAL THROMBUS FORMATION. THE ROOT CAUSE OF THIS OCCURRENCE COULD NOT BE DETERMINE, HOWEVER; THE MURAL THROMBUS WAS LIKELY A FUNCTION OF HEMODYNAMICS. THROMBUS FORMATION WAS DIRECTLY PROPORTIONAL TO GRAFT AND AORTIC DILATION AND MAINTAINED A REMARKABLY CONSTANT AORTIC LUMEN CROSS SECTIONAL AREA. THE AORTIC DILATION DID LIKELY OCCUR DUE TO FRAGILE AORTA. THE INTENDED TO TREAT ANEURYSM IS RESOLVING ALTHOUGH A NEW ANEURYSM DEVELOPED DISTAL THE ENDOGRAFT. THIS ANEURYSM EXTENDS TO THE CA. NO EVIDENCE TO SUGGEST THAT 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 STUDY: ON (B)(6) 2014, THE PATIENT RECEIVED A ZTLP-P-44-152-CI2 PROXIMAL COMPONENT AND A ZTLP-D-44-157-CI2 DISTAL COMPONENT. THERE WAS NO DIFFICULTY DEPLOYING THE DEVICES AND NO ADDITIONAL PROCEDURES WERE PERFORMED. ON THE COMPLETION ANGIOGRAM, THE SITE NOTED THAT THE DEVICES WERE PATENT WITH NO KINKS OR ENDOLEAKS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 (TWO DAYS POST-PROCEDURE). FOLLOW-UP CT SCANS: ON (B)(6) 2014 (1-MONTH FOLLOW-UP) (41 DAYS POST-PROCEDURE) ANALYSIS: ANEURYSM DIAMETER 61 MM. DEVICES PATENT AND INTACT WITH NO KINKS OR ENDOLEAKS. ON (B)(6) 2014 (6-MONTH FOLLOW-UP) (193 DAYS POST-PROCEDURE) ANALYSIS: ANEURYSM DIAMETER 55 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2015 (12-MONTH FOLLOW-UP) (319 DAYS POST-PROCEDURE) ANALYSIS: ANEURYSM DIAMETER 58 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2016 (2-YEAR FOLLOW-UP) (690 DAYS POST-PROCEDURE) ANALYSIS: ANEURYSM DIAMETER 55 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ANALYSIS NOTED: ¿THERE HAS BEEN AN INCREASE IN THE AMOUNT OF THROMBUS WITHIN THE GRAFT, BUT THIS IS NOT THREATENING PATENCY. THROMBUS EXTENDS BEYOND THE DISTAL ASPECT OF THE DEVICE, WITH LAMINAR THROMBUS ALSO PRESENT IN THE NATIVE VESSEL TO THE LEVEL OF THE CELIAC ORIGIN.¿ PATIENT OUTCOME: NO ADVERSE EVENTS OR SECONDARY INTERVENTIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, THE PATIENT RECEIVED A ZTLP-P-44-152-CI2 PROXIMAL COMPONENT AND A ZTLP-D-44-157-CI2 DISTAL COMPONENT. THERE WAS NO DIFFICULTY DEPLOYING THE DEVICES AND NO ADDITIONAL PROCEDURES WERE PERFORMED. ON THE COMPLETION ANGIOGRAM, THE SITE NOTED THAT THE DEVICES WERE PATENT WITH NO KINKS OR ENDOLEAKS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 (TWO DAYS POST-PROCEDURE). FOLLOW-UP CT SCANS: ON (B)(6) 2014 (1-MONTH FOLLOW-UP) (41 DAYS POST-PROCEDURE): ANALYSIS: ANEURYSM DIAMETER 61 MM. DEVICES PATENT AND INTACT WITH NO KINKS OR ENDOLEAKS. ON (B)(6) 2014 (6-MONTH FOLLOW-UP) (193 DAYS POST-PROCEDURE): ANALYSIS: ANEURYSM DIAMETER 55 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2015 (12-MONTH FOLLOW-UP) (319 DAYS POST-PROCEDURE): ANALYSIS: ANEURYSM DIAMETER 58 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2016 (2-YEAR FOLLOW-UP) (690 DAYS POST-PROCEDURE): ANALYSIS: ANEURYSM DIAMETER 55 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ANALYSIS NOTED: ¿THERE HAS BEEN AN INCREASE IN THE AMOUNT OF THROMBUS WITHIN THE GRAFT, BUT THIS IS NOT THREATENING PATENCY. THROMBUS EXTENDS BEYOND THE DISTAL ASPECT OF THE DEVICE, WITH LAMINAR THROMBUS ALSO PRESENT IN THE NATIVE VESSEL TO THE LEVEL OF THE CELIAC ORIGIN.¿ PATIENT OUTCOME: NO ADVERSE EVENTS OR SECONDARY INTERVENTIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628128 ZENITH ®TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR