BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH® TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 5931931 · Received September 7, 2016

    Report

    Report Number
    3002808486-2016-01029
    Event Type
    Malfunction
    Date Received
    September 7, 2016
    Date of Event
    July 28, 2016
    Report Date
    August 16, 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). SIMILAR TO DEVICE WITH 510K P140016. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE WITH 510K P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE PROVIDED INFORMATION IT WAS POSSIBLE TO CONFIRM THE REPORTED EVENT. THE IMAGING REVEALED A SLIGHT THICKENING OF THE GRAFT'S DISTAL END PRESENT AT ONE MONTH WAS PERSISTENT THROUGHOUT FOLLOW UP. IT¿S RELATIVELY RAPID APPEARANCE WAS CONSISTENT WITH A THIN THROMBUS LAYER. OVER THE COURSE OF THE FOLLOW UP, THE SLIGHTLY INCREASED THICKENING WAS CONSISTENT WITH AT LEAST PARTIAL TRANSFORMATION TO NEOINTIMAL HYPERPLASIA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, THE PATIENT UNDERWENT PLACEMENT OF A 26 MM X 105 MM TAPERED PROXIMAL COMPONENT (ZTLP-PT-26-105-CI3, LOT # E2998851). THE PROXIMAL EDGE OF THE GRAFT MATERIAL WAS DEPLOYED DISTAL TO THE LEFT CAROTID ARTERY. THE LEFT SUBCLAVIAN ARTERY WAS PARTIALLY COVERED AND WAS NOT REVASCULARIZED. THE MOST DISTAL STENT WAS DEPLOYED PROXIMAL TO THE CELIAC ARTERY. A MOLDING BALLOON WAS NOT USED. HYPOTENSION WAS NOT INDUCED AND NO SPINAL CORD PROTECTION ADJUNCTS WERE USED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 (NINE DAYS POST-PROCEDURE). ON (B)(6) 2015, CT SCAN (465 DAYS POST-PROCEDURE). ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, ENDOLEAK, OR MIGRATION. THE AORTIC INJURY WAS NO LONGER VISIBLE. (ON B)(6) 2016, CT SCAN (843 DAYS POST-PROCEDURE). ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, ENDOLEAK, OR MIGRATION. THE AORTIC INJURY WAS NO LONGER VISIBLE. IT WAS NOTED ¿NEW THROMBUS PRESENT WITHIN DISTAL STENT.¿ PATIENT OUTCOME: NO ADVERSE EVENTS OR SECONDARY INTERVENTIONS RELATED TO THE DEVICE HAVE BEEN REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014: THE PATIENT UNDERWENT PLACEMENT OF A 26 MM X 105 MM TAPERED PROXIMAL COMPONENT (ZTLP-PT-26-105-CI3, LOT # E2998851). THE PROXIMAL EDGE OF THE GRAFT MATERIAL WAS DEPLOYED DISTAL TO THE LEFT CAROTID ARTERY. THE LEFT SUBCLAVIAN ARTERY WAS PARTIALLY COVERED AND WAS NOT REVASCULARIZED. THE MOST DISTAL STENT WAS DEPLOYED PROXIMAL TO THE CELIAC ARTERY. A MOLDING BALLOON WAS NOT USED. HYPOTENSION WAS NOT INDUCED AND NO SPINAL CORD PROTECTION ADJUNCTS WERE USED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 (NINE DAYS POST-PROCEDURE). ON (B)(6) 2015 CT SCAN (465 DAYS POST-PROCEDURE). ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, ENDOLEAK, OR MIGRATION. THE AORTIC INJURY WAS NO LONGER VISIBLE. ON (B)(6) 2016 CT SCAN (843 DAYS POST-PROCEDURE). ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, ENDOLEAK, OR MIGRATION. THE AORTIC INJURY WAS NO LONGER VISIBLE. IT WAS NOTED ¿NEW THROMBUS PRESENT WITHIN DISTAL STENT.¿ PATIENT OUTCOME: NO ADVERSE EVENTS OR SECONDARY INTERVENTIONS RELATED TO THE DEVICE HAVE BEEN REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584314 ZENITH® TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other