BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH®TX2®LOW-PROFILE ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5938701 · Received September 9, 2016

    Report

    Report Number
    3002808486-2016-01040
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    August 4, 2016
    Report Date
    August 29, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 EXISTENCE OF THE REPORTED THROMBUS. THE THROMBUS DEVELOPED AT THE DISTAL ENDOGRAFT AND THEN IMPROVED BY SIX MONTHS. DEVELOPMENT OF A MORE SIGNIFICANT CONCENTRIC RIDGE CONSISTING OF AT LEAST SOME SURFACE THROMBUS BEGAN BETWEEN SIX MONTHS AND A YEAR. THE CONCURRENT AORTIC ARCH ELONGATION AND PRESERVED GRAFT LENGTH RAISES THE POSSIBILITY THAT THE LATER DEVELOPING RING CONSISTS OF AORTIC INFOLDING AS WELL AS LAYERED CHRONIC THROMBUS AND OR NEOINTIMAL HYPERPLASIA. THE PROXIMAL GRAFT DIAMETER WAS MATCHED TO THE AORTA. THE DISTAL GRAFT DIAMETER WAS NO MORE THAN 10% LARGER THAN THE DIAMETER AT IMPLANTATION (22MM) AND THREE YEARS (21MM). NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO STUDY: ON (B)(6) 2013, THE PATIENT UNDERWENT PLACEMENT OF A 24 MM X 105 MM PROXIMAL COMPONENT (ZTLP-P-24-105-CI3, LOT # E2998714). 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. HYPOTENSION WAS NOT INDUCED AND NO SPINAL CORD PROTECTION ADJUNCTS WERE USED. ANALYSIS OF THE COMPLETION ANGIOGRAM NOTED A PATENT GRAFT WITH NO KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 (THREE DAYS POST-PROCEDURE). ON (B)(6) 2016, CT SCAN (1147 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. ANALYSIS NOTED THROMBUS PRESENT AT THE DISTAL GRAFT. PATIENT OUTCOME: NO ADVERSE EVENTS OR SECONDARY INTERVENTIONS RELATED TO THE DEVICE HAVE BEEN REPORTED FOR THIS PATIENT. THE TREATING PHYSICIAN WILL BE NOTIFIED OF THE THROMBUS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2013, THE PATIENT UNDERWENT PLACEMENT OF A 24 MM X 105 MM PROXIMAL COMPONENT (ZTLP-P-24-105-CI3, LOT # E2998714). 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. HYPOTENSION WAS NOT INDUCED AND NO SPINAL CORD PROTECTION ADJUNCTS WERE USED. ANALYSIS OF THE COMPLETION ANGIOGRAM NOTED A PATENT GRAFT WITH NO KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 (THREE DAYS POST-PROCEDURE). ON (B)(6) 2016 CT SCAN (1147 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. ANALYSIS NOTED THROMBUS PRESENT AT THE DISTAL GRAFT. PATIENT OUTCOME: NO ADVERSE EVENTS OR SECONDARY INTERVENTIONS RELATED TO THE DEVICE HAVE BEEN REPORTED FOR THIS PATIENT. THE TREATING PHYSICIAN WILL BE NOTIFIED OF THE THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591236 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 28 YR Life Threatening