BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH®TX2®LOW-PROFILE ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5531110 · Received March 29, 2016

    Report

    Report Number
    3002808486-2016-00145
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    November 23, 2015
    Report Date
    January 25, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    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: BASED ON THE INVESTIGATION IT WAS NOT POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. IN THIS CASE THE ENDOGRAFT DEMONSTRATED SLOW BUT PROGRESSIVE MURAL THROMBUS FORMATION BEGINNING AFTER 3 WEEKS. 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 776 DAYS POST-PROCEDURE. ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-24-105-CI3 PROXIMAL COMPONENT. PER SITE ANALYSIS, THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2013 CT SCAN (20 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, OR INFOLDING. AN ENDOLEAK OF UNKNOWN TYPE WAS NOTED. ON (B)(6) 2015 CT SCAN (776 DAYS POST-PROCEDURE): CORE LAB ANALYSIS: NEW THROMBUS PRESENT AT DISTAL STENT. 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 776 DAYS POST-PROCEDURE. ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-24-105-CI3 PROXIMAL COMPONENT. PER SITE ANALYSIS, THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2013, CT SCAN (20 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, OR INFOLDING. AN ENDOLEAK OF UNKNOWN TYPE WAS NOTED. ON (B)(6) 2015, CT SCAN (776 DAYS POST-PROCEDURE): CORE LAB ANALYSIS: NEW THROMBUS PRESENT AT DISTAL STENT. 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
    189565 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 26 YR Other