BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH®TX2®LOW-PROFILE ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5518971 · Received March 23, 2016

    Report

    Report Number
    3002808486-2016-00141
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    April 9, 2014
    Report Date
    July 31, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    (B)(4). DEVICE IS SIMILAR TO DEVICE WITH 510(K) P140016. SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE IMAGING REVIEW AND DESCRIPTION OF EVENT IT WAS NOT POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. THROMBUS DEVELOPED INITIALLY IN THE CURVATURE THREE WEEKS POST IMPLANTATION. THIS THROMBUS RESOLVED BY 6 MONTHS. THROMBUS IN THE DISTAL ENDOGRAFT DEVELOPED BETWEEN 1 MONTH AND 6 MONTHS. THE PATIENT LIKELY IMPROVED DUE TO ANTICOAGULANT TREATMENT BETWEEN YEAR 1 AND 2. THROMBUS IN THE STENT GRAFT IN RELATION TO PATIENTS TREATED FOR BLUNT THORACIC AORTIC INJURY (BTAI) INDICATION WAS PREVIOUSLY DESCRIBED IN THE SCIENTIFIC LITTERATURE. THE MECHANISM FOR STENT GRAFT THROMBUS IN BTAI PATIENTS WAS 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: CIRCUMFERENTIAL THROMBUS IN DISTAL PORTION OF GRAFT 341 DAYS POST-PROCEDURE ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-26-105-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. 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 (21 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 (36 DAYS POST-PROCEDURE). ON (B)(6) 2013 CT SCAN (160 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF MIGRATION, KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2014 CT SCAN (341 DAYS POST-PROCEDURE): ANALYSIS: CIRCUMFERENTIAL THROMBUS PRESENT IN DISTAL PORTION OF GRAFT. ON (B)(6) 2015 CT SCAN (727 DAYS POST-PROCEDURE): ANALYSIS: "INTRALUMINAL THROMBUS AT DISTAL STENT HAS CHANGED MORPHOLOGY, AND PARTIALLY RESOLVED AS COMPARED TO THE 12 MONTH SCAN." 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: CIRCUMFERENTIAL THROMBUS IN DISTAL PORTION OF GRAFT 341 DAYS POST-PROCEDURE ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-26-105-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. 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 (21 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 (36 DAYS POST-PROCEDURE). ON (B)(6) 2013 CT SCAN (160 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF MIGRATION, KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2014 CT SCAN (341 DAYS POST-PROCEDURE): ANALYSIS: CIRCUMFERENTIAL THROMBUS PRESENT IN DISTAL PORTION OF GRAFT. ON (B)(6) 2015 CT SCAN (727 DAYS POST-PROCEDURE): ANALYSIS: "INTRALUMINAL THROMBUS AT DISTAL STENT HAS CHANGED MORPHOLOGY, AND PARTIALLY RESOLVED AS COMPARED TO THE 12 MONTH SCAN." 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
    177212 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 20 YR Other