BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH®TX2®LOW-PROFILE ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5531105 · Received March 29, 2016

    Report

    Report Number
    3002808486-2016-00147
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    January 12, 2015
    Report Date
    November 23, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    PMA / PMN Number
    P140016
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS SIMILAR TO DEVICE WITH 510(K) P140016. SUMMARY OF INVESTIGATION FINDINGS: BASED ON THE REVIEW OF PROVIDED IMAGING IT WAS NOT POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. IN THIS CASE ENDOGRAFT THROMBUS DEVELOPED DURING THE FIRST MONTH, IMPROVED BY 6 MONTHS AND THEN SLIGHTLY WORSENED BY 12 MONTHS. EXCLUDING THE DISTAL STENT, THROMBUS WITHIN THE GRAFT WAS LOCATED ALONG THE INNER AORTIC CURVATURE ONLY WHERE FABRIC WAS REDUNDANT FROM STENT CROWDING. THE DISTAL STENT THROMBUS HAD A STEREOTYPIC CONCENTRIC DISTRIBUTION AT THE DISTAL STENT TRAILING EDGE WITH ONE SHEET LIKE COMPONENT IN BETWEEN TWO ADJACENT STENT ELEMENTS. THE THROMBUS SIGNIFICANTLY IMPROVED AFTER ONE MONTH. THE PATIENT MAY HAVE BEEN ANTICOAGULATED. THROMBUS IN THE STENT GRAFT IN RELATION TO PATIENTS TREATED FOR BTAI INDICATION WAS PREVIOUSLY DESCRIBED IN THE PUBLIC SCIENTIFIC LITERATURE. THE MECHANISM FOR STENT GRAFT THROMBUS IN 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, THE PATIENT RECEIVED A ZTLP-P-24-105-CI3 PROXIMAL COMPONENT. THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2015 CT SCAN (346 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF MIGRATION, KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. IT WAS NOTED "DISSECTION FLAP OR THROMBUS AT DISTAL MOST THORACIC GRAFT APPEARS MORE PROMINENT." 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: DISSECTION FLAP OR THROMBUS 346 DAYS POST-PROCEDURE. ON (B)(6) 2014, THE PATIENT RECEIVED A ZTLP-P-24-105-CI3 PROXIMAL COMPONENT. THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2015 CT SCAN (346 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF MIGRATION, KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. IT WAS NOTED "DISSECTION FLAP OR THROMBUS AT DISTAL MOST THORACIC GRAFT APPEARS MORE PROMINENT." 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
    188410 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 19 YR Other