BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH®TX2®LOW-PROFILE ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5531103 · Received March 29, 2016

    Report

    Report Number
    3002808486-2016-00146
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    November 8, 2014
    Report Date
    August 11, 2015
    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 INVESTIGATION IT WAS NOT POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. IN THIS CASE A SMALL SHEET-LIKE DISTAL GRAFT FILLING DEFECT ALONG THE INNER AORTIC CURVATURE CONSISTENT WITH THROMBUS DEVELOPED BETWEEN IMPLANTATION AND 1 MONTH. LT IMPROVED BETWEEN 1 AND 6 MONTHS AND WAS STABLE THROUGH 12 MONTHS. THE THROMBUS OCCURRED IN BETWEEN THE TWO MOST DISTAL GRAFT STENT BODIES WHERE AORTIC CURVATURE CAUSED SLIGHTLY FABRIC REDUNDANCY. IN COMPARISON TO OTHER REVIEWED CASES OF MURAL THROMBUS, THE AMOUNT OF THROMBUS IS MINIMAL AND MAY CORRELATE WITH BETTER EARLY GRAFT EXPANSION BECAUSE THE STENT DIAMETER MATCHED AORTIC DIAMETER 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: SMALL THROMBUS 363 DAYS POST-PROCEDURE. ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-26-105-CI3 PROXIMAL COMPONENT. THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2014 CT SCAN (363 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF MIGRATION, KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. THE SITE NOTED "SMALL INTRA-STENT FILLING DEFECT AT THE LEVEL OF THE DESCENDING THORACIC AORTA MAY REPRESENT A SMALL THROMBUS." NO TREATMENT WAS PERFORMED. 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: SMALL THROMBUS 363 DAYS POST-PROCEDURE. ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-26-105-CI3 PROXIMAL COMPONENT. THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2014 CT SCAN (363 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF MIGRATION, KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. THE SITE NOTED "SMALL INTRA-STENT FILLING DEFECT AT THE LEVEL OF THE DESCENDING THORACIC AORTA MAY REPRESENT A SMALL THROMBUS." NO TREATMENT WAS PERFORMED. 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
    188498 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 55 YR Other