BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH®TX2®LOW-PROFILE ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5531154 · Received March 29, 2016

    Report

    Report Number
    3002808486-2016-00142
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    August 26, 2013
    Report Date
    October 28, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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). PT WEIGHT: UNKNOWN AS INFORMATION WAS NOT PROVIDED. PMA 510(K): DEVICE IS SIMILAR TO DEVICE WITH 510(K) P140016. SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE INVESTIGATION IT WAS NOT POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. IN THIS CASE BOTH STENT GRAFTS WERE IMPLANTED IN A SHORTER SEGMENT AORTA THAN THEY WERE INTENDED TO BE IMPLANTED IN. THIS CAUSED A CONSTRICTION THAT MAY HAVE CONTRIBUTED TO THE THROMBUS FORMATION. THE MECHANISM FOR STENT GRAFT THROMBUS IN BLUNT THORACIC AORTIC INJURY (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.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: DISTAL GRAFT THROMBUS 66 DAYS POST-PROCEDURE. ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-32-109-CI3 PROXIMAL COMPONENT AND A ZTLP-P-32-109-CI3 PROXIMAL COMPONENT. THE SECOND COMPONENT WAS PLACED TO INCREASE DISTAL COVERAGE OF THE INJURY. PER SITE ANALYSIS, THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. ON (B)(6) 2013 CT SCAN (4 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF COMPONENT SEPARATION, KINK, BARB SEPARATION, STENT FRACTURE, INFOLDING, OR ENDOLEAK. IT WAS NOTED "DEVICE COMPRESSION CONFIRMED BY DIAMETER REDUCTION >60% IN TWO ORTHOGONAL PROJECTIONS" OF THE MOST PROXIMAL COMPONENT. ON (B)(6) 2013 NON-CONTRAST CT SCAN (33 DAYS POST-PROCEDURE): ANALYSIS: NO EVIDENCE OF COMPONENT SEPARATION, MIGRATION, KINK, BARB SEPARATION, STENT FRACTURE, OR INFOLDING. DEVICE COMPRESSION WAS NOTED TO APPEAR UNCHANGED FROM PREVIOUS CT SCAN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 (33 DAYS POST-PROCEDURE). ON (B)(6) 2013 CT SCAN (66 DAYS POST-PROCEDURE): THROMBUS PRESENT WITHIN DISTAL GRAFT. DEVICE COMPRESSION UNCHANGED. ON (B)(6) 2014 (335 DAYS POST-PROCEDURE), A SECONDARY INTERVENTION WAS PERFORMED TO TREAT THE DEVICE COMPRESSION. BALLOON ANGIOPLASTY WAS PERFORMED AND WAS DEEMED SUCCESSFUL. ON (B)(6) 2014 CT SCAN (347 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF COMPONENT SEPARATION, KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. THROMBUS PRESENT WITHIN DISTAL GRAFT. PATIENT OUTCOME: NO ADVERSE EVENTS RELATED TO THE DEVICE HAVE BEEN REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: DISTAL GRAFT THROMBUS 66 DAYS POST-PROCEDURE. ON (B)(6) 2013, THE PATIENT RECEIVED A ZTLP-P-32-109-CI3 PROXIMAL COMPONENT AND A ZTLP-P-32-109-CI3 PROXIMAL COMPONENT. THE SECOND COMPONENT WAS PLACED TO INCREASE DISTAL COVERAGE OF THE INJURY. PER SITE ANALYSIS, THE COMPLETION ANGIOGRAM REVEALED A PATENT GRAFT WITH NO EVIDENCE OF KINK, COMPRESSION, INFOLDING, OR ENDOLEAK. (B)(6) 2013 CT SCAN (4 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF COMPONENT SEPARATION, KINK, BARB SEPARATION, STENT FRACTURE, INFOLDING, OR ENDOLEAK. IT WAS NOTED "DEVICE COMPRESSION CONFIRMED BY DIAMETER REDUCTION >60% IN TWO ORTHOGONAL PROJECTIONS" OF THE MOST PROXIMAL COMPONENT. (B)(6) 2013 NON-CONTRAST CT SCAN (33 DAYS POST-PROCEDURE): ANALYSIS: NO EVIDENCE OF COMPONENT SEPARATION, MIGRATION, KINK, BARB SEPARATION, STENT FRACTURE, OR INFOLDING. DEVICE COMPRESSION WAS NOTED TO APPEAR UNCHANGED FROM PREVIOUS CT SCAN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 (33 DAYS POST-PROCEDURE). (B)(6) 2013 CT SCAN (66 DAYS POST-PROCEDURE): THROMBUS PRESENT WITHIN DISTAL GRAFT. DEVICE COMPRESSION UNCHANGED. ON (B)(6) 2014 (335 DAYS POST-PROCEDURE), A SECONDARY INTERVENTION WAS PERFORMED TO TREAT THE DEVICE COMPRESSION. BALLOON ANGIOPLASTY WAS PERFORMED AND WAS DEEMED SUCCESSFUL. (B)(6) 2014 CT SCAN (347 DAYS POST-PROCEDURE): ANALYSIS: PATENT GRAFT WITH NO EVIDENCE OF COMPONENT SEPARATION, KINK, BARB SEPARATION, STENT FRACTURE, COMPRESSION, INFOLDING, OR ENDOLEAK. THROMBUS PRESENT WITHIN DISTAL GRAFT. PATIENT OUTCOME: NO ADVERSE EVENTS RELATED TO THE DEVICE HAVE BEEN REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189710 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 38 YR Other| R