BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ®TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5845995 · Received August 4, 2016

    Report

    Report Number
    3002808486-2016-00804
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    July 18, 2016
    Report Date
    July 20, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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). SIMILAR TO DEVICE UNDER 510(K): P140016. SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE INFORMATION PROVIDED FOR THIS INVESTIGATION, IT WAS POSSIBLE TO CONFIRM THE REPORTED EVENT, TYPE IB ENDOLEAK. THE ROOT CAUSE OF THIS EVENT CAN BE RELATED TO AORTIC LENGTHENING, SUPERIOR MOVEMENT OF STENT GRAFT, AND EXPANSION OF THE DISTAL SEALING ZONE. THE ENDOLEAK WAS EXCLUDE AFTERWARDS BY A DISTAL EXTENSION IMPLANTATION. THE GRAFT KINK WAS STRAIGHTENED BY THE EXTENSION AND AN ADDITION PROXIMAL TAPERED COMPONENT. ACCORDING TO THE COMPLAINT HISTORY, THE LOSS OF THE DISTAL SEALING ZONE OCCURS WHEN ONE COMPONENT IS IMPLANTED. 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 OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, A PROXIMAL COMPONENT (ZTLP-P-40-167-CI; LOT # E284880) WAS IMPLANTED WITHOUT DIFFICULTY. NO ADDITIONAL PROCEDURES WERE PERFORMED. ON THE COMPLETION ANGIOGRAM, THE ANALYSIS NOTED THAT THE DEVICE WAS PATENT WITH NO KINKS OR ENDOLEAKS. FOLLOW UP CT: ON 2 YR: (B)(6) 2016: ANALYSIS: ANEURYSM DIAMETER 72 MM. DEVICE PATENT AND INTACT WITH CRANIAL MIGRATION AND KINK. NO ENDOLEAKS WERE NOTED. THE FOLLOWING COMMENT WAS MADE BY THE ANALYSIS MD: ¿MIGRATION OF THE CAUDAL ASPECT OF THE DEVICE, FOLDING INTO ITSELF, WITH THE DISTAL GRAFT NOW IN THE TAA. ¿ ON 30 MO: (B)(6) 2016: SITE: ANEURYSM DIAMETER 74 MM. DEVICE PATENT AND INTACT WITH CRANIAL MIGRATION AND KINK. A DISTAL TYPE I ENDOLEAK WAS NOTED. PATIENT OUTCOME: THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS AFTER THE INDEX PROCEDURE. BEGINNING AT 12 MO, THE SITE INCREASED THE FREQUENCY OF FOLLOW-UP CT IMAGING TO EVERY 6 MONTHS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, A PROXIMAL COMPONENT (ZTLP-P-40-167-CI; LOT # E284880) WAS IMPLANTED WITHOUT DIFFICULTY. NO ADDITIONAL PROCEDURES WERE PERFORMED. ON THE COMPLETION ANGIOGRAM, THE ANALYSIS NOTED THAT THE DEVICE WAS PATENT WITH NO KINKS OR ENDOLEAKS. FOLLOW-UP CT¿S: 1 MO: (B)(6) 2014 ANALYSIS: ANEURYSM DIAMETER 66 MM DEVICE PATENT AND INTACT WITH NO ENDOLEAKS OR KINKS. SIX MO: (B)(6) 2014 ANALYSIS: ANEURYSM DIAMETER 66 MM DEVICE PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. TWELVE MO: (B)(6) 2015, THE SITE FIRST NOTED MIGRATION AND KINK ON THE 12 MONTHS IMAGING ALSO. ANALYSIS: ANEURYSM DIAMETER 68 MM DEVICE PATENT AND INTACT WITH CRANIAL MIGRATION AND KINK DUE TO CENTRAL ANGULATION IN THE ANEURYSM AND DEVICE. NO ENDOLEAKS WERE NOTED. MIGRATION OF BOTH ENDS WAS NOTED. THE SITE INCREASED THE FREQUENCY OF FOLLOW-UP CT IMAGING AND ASSESSMENTS TO EVERY 6 MONTHS. EIGHTEEN MO: (B)(6) 2015 ANALYSIS: ANEURYSM DIAMETER 67 MM DEVICE PATENT AND INTACT WITH CRANIAL MIGRATION AND KINK. NO ENDOLEAKS WERE NOTED. TWO YR: (B)(6) 2016 ANALYSIS: ANEURYSM DIAMETER 72 MM DEVICE PATENT AND INTACT WITH CRANIAL MIGRATION AND KINK. NO ENDOLEAKS WERE NOTED. THIRTY MO: (B)(4) 2016. SITE: ANEURYSM DIAMETER 74 MM DEVICE PATENT AND INTACT WITH CRANIAL MIGRATION AND KINK. A DISTAL TYPE I ENDOLEAK WAS NOTED. ANALYSIS SHOWED THAT THE DEVICE WAS PATENT AND INTACT WITH CRANIAL MIGRATION AND NO KINK. A DISTAL TYPE I ENDOLEAK WAS NOTED. MAXIMUM ANEURYSM DIAMETER 77 MM. ADDITIONAL INFORMATION RECEIVED 28NOV2016: ON (B)(6) 2016, TEVAR WAS PERFORMED WITH ADDITION OF A ZTA-D-36-142-W IN THE DISTAL THORACIC AORTA, AND A ZTA-PT-40-36-167-W INSIDE THE EXISTING THORACIC AORTIC ENDOGRAFT WITH OVERLAP DISTALLY WITH THE DISTAL COMPONENT. PATIENT OUTCOME: THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS AFTER THE INDEX PROCEDURE. BEGINNING AT 12 MO, THE SITE INCREASED THE FREQUENCY OF FOLLOW-UP CT IMAGING TO EVERY 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498621 ZENITH ®TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Life Threatening