BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH®TX2®LOW-PROFILE ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5531106 · Received March 29, 2016

    Report

    Report Number
    3002808486-2016-00144
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    August 26, 2014
    Report Date
    September 17, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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

    (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 CONCENTRIC DISTAL MURAL ENDOGRAFT WAS DEVELOPED BETWEEN MONTH 1 AND YEAR 1. THIS COULD BE ASSOCIATED WITH A SIZE DIFFERENTIAL FROM THE STENT GRAFT THAT EXPANDED THE AORTA TO 23 MM AND THE ADJACENT DISTAL AORTA THAT AS ONLY 19 MM. THE MECHANISM FOR STENT GRAFT THROMBUS IN BLUNT THORACIC AORTIC INJURY (BTAI) PATIENTS 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: DISTAL GRAFT THROMBUS AT 351 DAYS POST-PROCEDURE. ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-24-105-CI3 PROXIMAL COMPONENT. PER SITE ASSESSMENT, THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2014 CT SCAN (351 DAYS POST-PROCEDURE): ANALYSIS: THROMBUS PRESENT WITHIN DISTAL GRAFT. ON (B)(6) 2015 CT SCAN (743 DAYS POST-PROCEDURE): ANALYSIS: THROMBUS PRESENT WITHIN DISTAL GRAFT, UNCHANGED FROM PRIOR TIMEPOINT. PATIENT OUTCOME: NO ADVERSE EVENTS RELATED TO THE DEVICE OR SECONDARY INTERVENTIONS HAVE BEEN REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: DISTAL GRAFT THROMBUS AT 351 DAYS POST-PROCEDURE. ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-24-105-CI3 PROXIMAL COMPONENT. PER SITE ASSESSMENT, THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2014 CT SCAN (351 DAYS POST-PROCEDURE): ANALYSIS: THROMBUS PRESENT WITHIN DISTAL GRAFT. ON (B)(6) 2015 CT SCAN (743 DAYS POST-PROCEDURE): ANALYSIS: THROMBUS PRESENT WITHIN DISTAL GRAFT, UNCHANGED FROM PRIOR TIMEPOINT. PATIENT OUTCOME: NO ADVERSE EVENTS RELATED TO THE DEVICE OR SECONDARY INTERVENTIONS HAVE BEEN REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188510 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 21 YR Other