BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 LOW PROFILE TAA ENDOVASCULAR GRAFT DISTAL EXTENSION

    MDR report key: 5976253 · Received September 26, 2016

    Report

    Report Number
    3002808486-2016-01139
    Event Type
    Injury
    Date Received
    September 26, 2016
    Date of Event
    January 8, 2015
    Report Date
    April 17, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE PROVIDED INFORMATION, THE EXISTENCE OF THE REPORTED THROMBUS FORMATION WAS CONFIRMED. THE AORTA WITH THE EXCEPTION OF THE ANEURYSM WAS REMARKABLY FREE OF ATHEROSCLEROSIS AND NOT DILATED. AORTIC DIAMETER WAS NORMAL PROXIMAL AND DISTAL MEASURING 25 AND 20 MM RESPECTIVELY. THE DENSE CALCIFICATION SUPPORTS A VERY LONG STANDING ANEURYSM. THE LOCATION ALONG THE INNER AORTIC CURVATURE WAS AT THE LOCATION COMMON FOR TRAUMATIC TRANSECTIONS AND SIGNIFICANTLY LESS COMMON FOR ATHEROSCLEROTIC DISEASE. THESE OBSERVATIONS ALONG WITH THE PATIENT'S RELATIVELY YOUNG AGE SUPPORT A LONG STANDING CALCIFIED PSEUDOANEURYSM FROM REMOTE TRANSECTION RATHER THAN AN ATHEROSCLEROTIC ANEURYSM. IN ADDITION, THE DEVICE WAS SIGNIFICANTLY OVERSIZED RELATIVE TO THE DISTAL AORTA WHERE THE 28 MM STENT BODIES WERE CONSTRAINED TO 20 MM, FOLDS LONGITUDINAL TO THE AORTIC LUMEN OCCURRED IN BETWEEN STENT APICES. THE MECHANISM FOR STENT GRAFT THROMBUS IN BTAI PATIENTS ARE UNKNOWN BUT E.G. 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: ON (B)(6) 2012, THE PATIENT RECEIVED A ZTLP-P-28-155-CI PROXIMAL COMPONENT AND A LED-28-108-CI DISTAL EXTENSION. THERE WAS NO DIFFICULTY DEPLOYING THE DEVICES AND NO ADDITIONAL PROCEDURES WERE PERFORMED. ON THE COMPLETION ANGIOGRAM, THE SITE NOTED THAT THE DEVICES WERE PATENT WITH NO KINKS OR ENDOLEAKS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 (FIVE DAYS POST-PROCEDURE). FOLLOW-UP CT SCANS: (B)(6) 2012 (1-MONTH FOLLOW-UP) (29 DAYS POST-PROCEDURE). ANALYSIS: ANEURYSM DIAMETER 71 MM. DEVICES PATENT AND INTACT WITH NO KINKS OR ENDOLEAKS. A "MILD KEYHOLE DEFORMITY" WAS NOTED. ON (B)(6) 2012 (6-MONTH FOLLOW-UP) (184 DAYS POST-PROCEDURE). ANALYSIS: ANEURYSM DIAMETER 62 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2013 (12-MONTH FOLLOW-UP) (386 DAYS POST-PROCEDURE). ANALYSIS: ANEURYSM DIAMETER 62 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2013 (2-YEAR FOLLOW-UP) (701 DAYS POST-PROCEDURE). ANALYSIS: ANEURYSM DIAMETER 65 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2015 (3-YEAR FOLLOW-UP ) (1093 DAYS POST-PROCEDURE). ANALYSIS: ANEURYSM DIAMETER 62 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ANALYSIS NOTED: "THERE HAS BEEN AN INCREASE IN THE THROMBUS FORMATION WITHIN THE DISTAL END OF THE DEVICE. THE THROMBUS IS NOW ALSO EXTENDING DISTAL TO THE DEVICE. THIS MAY BE RELATED TO INFOLDING OF THE GRAFT MATERIAL AT THIS LEVEL. IT IS CAUSING <50% DECREASED IN LUMEN DIAMETER BUT IS IRREGULAR AND NOT ATTACHED ENTIRELY TO THE AORTIC WALL." THE PATIENT WAS TREATED WITH MEDICATION. PATIENT OUTCOME: NO SECONDARY INTERVENTIONS HAVE BEEN REPORTED. THE PATIENT WITHDREW FROM THE STUDY ON (B)(6) 2016 (1476 DAYS POST-PROCEDURE).

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO POST MARKET CLINICAL STUDY: ON (B)(6) 2012, THE PATIENT RECEIVED A ZTLP-P-28-155-CI PROXIMAL COMPONENT AND A LED-28-108-CI DISTAL EXTENSION. THERE WAS NO DIFFICULTY DEPLOYING THE DEVICES AND NO ADDITIONAL PROCEDURES WERE PERFORMED. ON THE COMPLETION ANGIOGRAM, THE SITE NOTED THAT THE DEVICES WERE PATENT WITH NO KINKS OR ENDOLEAKS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 (FIVE DAYS POST-PROCEDURE). FOLLOW-UP CT SCANS: ON (B)(6) 2012 (1-MONTH FOLLOW-UP) (29 DAYS POST-PROCEDURE) ANALYSIS: ANEURYSM DIAMETER 71 MM. DEVICES PATENT AND INTACT WITH NO KINKS OR ENDOLEAKS. A ¿MILD KEYHOLE DEFORMITY¿ WAS NOTED. ON (B)(6) 2012 (6-MONTH FOLLOW-UP) (184 DAYS POST-PROCEDURE) ANALYSIS: ANEURYSM DIAMETER 62 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2013 (12-MONTH FOLLOW-UP) (386 DAYS POST-PROCEDURE) ANALYSIS: ANEURYSM DIAMETER 62 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2013 (2-YEAR FOLLOW-UP) (701 DAYS POST-PROCEDURE) ANALYSIS: ANEURYSM DIAMETER 65 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2015 (3-YEAR FOLLOW-UP) (1093 DAYS POST-PROCEDURE) ANALYSIS: ANEURYSM DIAMETER 62 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ANALYSIS NOTED: ¿THERE HAS BEEN AN INCREASE IN THE THROMBUS FORMATION WITHIN THE DISTAL END OF THE DEVICE. THE THROMBUS IS NOW ALSO EXTENDING DISTAL TO THE DEVICE. THIS MAY BE RELATED TO INFOLDING OF THE GRAFT MATERIAL AT THIS LEVEL. IT IS CAUSING <50% DECREASED IN LUMEN DIAMETER BUT IS IRREGULAR AND NOT ATTACHED ENTIRELY TO THE AORTIC WALL.¿ THE PATIENT WAS TREATED WITH MEDICATION. PATIENT OUTCOME: NO SECONDARY INTERVENTIONS HAVE BEEN REPORTED. THE PATIENT WITHDREW FROM THE STUDY ON (B)(6) 2016 (1476 DAYS POST-PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629258 ZENITH TX2 LOW PROFILE TAA ENDOVASCULAR GRAFT DISTAL EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening