BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH®TX2®LOW-PROFILE ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5530885 · Received March 29, 2016

    Report

    Report Number
    3002808486-2016-00143
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    July 29, 2013
    Report Date
    September 4, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE #: (B)(4). DEVICE IS SIMILAR TO DEVICE WITH 510(K) P140016. SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS NOT POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. IN THIS CASE THE IMAGING CONFIRMED MURAL THROMBUS FORMATION. THE STENT WAS PERFECTLY MATCHED TO THE AORTIC DIAMETER; CONSEQUENTLY THE FABRIC AT THE STENT LEVEL WAS STRETCHED SMOOTHER THAN IN AN OVERSIZED SITUATION. THESE AREAS WERE FREE OF MURAL THROMBUS WHERE IT IS TYPICALLY CONTINUOUS. THE MECHANISM FOR STENT GRAFT THROMBUS IN PATIENTS WITH BLUNT THORACIC AORTIC INJURY ARE UNKNOWN BUT STENT GRAFT SIZING HAS BEEN PROPOSED AS A FACTOR. IN THIS CASE NOTHING INDICATES THAT THE DEVICES WERE 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: LINEAR THROMBUS WITHIN DEVICE LUMEN AT PROXIMAL DESCENDING AORTIC SEGMENT. ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-18-105-CI3 PROXIMAL COMPONENT. THE PROXIMAL EDGE OF THE GRAFT MATERIAL WAS DEPLOYED DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE MOST DISTAL STENT WAS DEPLOYED PROXIMAL TO THE CELIAC ARTERY. A MOLDING BALLOON WAS NOT USED. THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. PATIENT OUTCOME: ON (B)(6) 2013, CT SCAN (34 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. IT WAS NOTED ¿THREE AREAS OF APPARENT LINEAR THROMBUS WITHIN THE DEVICE LUMEN AT THE PROXIMAL DESCENDING THORACIC AORTIC SEGMENT.¿ ON (B)(6) 2015, CT SCAN (797 DAYS POST-PROCEDURE): ANALYSIS: LINEAR THROMBUS APPEARS UNCHANGED. NO ADVERSE EVENTS OR SECONDARY INTERVENTIONS HAVE BEEN REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: LINEAR THROMBUS WITHIN DEVICE LUMEN AT PROXIMAL DESCENDING AORTIC SEGMENT. ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-18-105-CI3 PROXIMAL COMPONENT. THE PROXIMAL EDGE OF THE GRAFT MATERIAL WAS DEPLOYED DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE MOST DISTAL STENT WAS DEPLOYED PROXIMAL TO THE CELIAC ARTERY. A MOLDING BALLOON WAS NOT USED. THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. PATIENT OUTCOME: ON (B)(6) 2013 CT SCAN (34 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. IT WAS NOTED "THREE AREAS OF APPARENT LINEAR THROMBUS WITHIN THE DEVICE LUMEN AT THE PROXIMAL DESCENDING THORACIC AORTIC SEGMENT." ON (B)(6) 2015 CT SCAN (797 DAYS POST-PROCEDURE): ANALYSIS: LINEAR THROMBUS APPEARS UNCHANGED. NO ADVERSE EVENTS OR SECONDARY INTERVENTIONS HAVE BEEN REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188485 ZENITH®TX2®LOW-PROFILE ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other