BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 10790689 · Received November 5, 2020

    Report

    Report Number
    3002808486-2020-01004
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    November 9, 2017
    Report Date
    July 21, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002236131
    PMA / PMN Number
    P070016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT WAS OPENED TO ADDRESS A FINDING OF LAMINAR THROMBUS IN A ZTEG-2PT-42-32-165-PF DEVICE, NOTED IN AN IMAGING REVIEW PERFORMED FOR COOK¿S INVESTIGATION OF RELATED COMPLAINTS. A 74-YEAR-OLD FEMALE STUDY PATIENT UNDERWENT TREATMENT FOR A THORACOABDOMINAL ANEURYSM. REPORTED PATIENT HISTORY INCLUDES PERIPHERAL VASCULAR DISEASE, SIGMADIVERTICULITIS, STOMACH CANCER, TIA, AND SMOKING (CURRENT). ON (B)(6) 2017 THE PATIENT RECEIVED THE FOLLOWING DEVICES: ZTA-PT-44-40-179, TBRANCH-34-18-202, ZTEG-2PT-42-32-165-PF, UNIBODY-22-132, ZSLE-16-74-ZT (RIGHT ILIAC LEG GRAFT), ZSLE-20-74-ZT (LEFT ILIAC LEG GRAFT). AS PER THE IMAGING REVIEW, FROM A 6-MONTH POSTOP CT STUDY, DATED (B)(6) 2018, A ZENITH THORACIC ALPHA (ZTA TAPERED 44 X 40 X 179 MM) GRAFT BEGINS 41 MM DISTAL TO THE LSA. THERE IS A LONG LENGTH OF PROXIMAL SEAL. THE ZTA GRAFT HAS MILD TO MODERATE PARTIAL LAMINAR THROMBUS THROUGHOUT. A ZTEG THORACIC GRAFT OVERLAPS 53 MM WITH THE DISTAL ZTA GRAFT AND EXTENDS TO THE DISTAL THORACIC AORTA. THERE IS MODERATE TORTUOSITY ADJACENT TO THE OVERLAP SEGMENT BUT NO ENDOLEAK IS SEEN HERE. THE ZTEG GRAFT HAS MILD INTERMITTENT LAMINAR THROMBUS. THE ZTEG GRAFT DIAMETER NARROWS TO 30 MM DISTALLY. FROM A 18-MONTH POSTOP CT STUDY, DATED (B)(6) 2021, THE THROMBUS INSIDE THE ZTEG APPEARS TO HAVE RESOLVED. NO INFORMATION REGARDING MEDICAL TREATMENT IN RELATION TO THIS EVENT HAS BEEN RECEIVED. RELATED (B)(4) WAS OPENED TO ADDRESS THROMBUS INSIDE THE OVERLAPPING ZTA-PT-44-40-179 DEVICE. THE FINDINGS WERE NOTED IN A REVIEW OF TWO PROVIDED POSTOPERATIVE CT STUDIES DATED (B)(6)2018 AND (B)(6) 2019 PERFORMED FOR THE INVESTIGATION BY AN EXPERT IMAGING REVIEWER. AS PER IMPRESSIONS IN THE IMAGING REVIEW, THE MODERATE LAMINAR THROMBUS WITHIN THE ZTA AND ZTEG GRAFTS AT 6 MONTHS IS LIKELY DUE TO NON-LAMINAR FLOW FROM GRAFT TORTUOSITY AND CALIBER CHANGE. THE INSTRUCTIONS FOR USE (IFU) SHIPPED WITH THIS TYPE OF DEVICE DOES NOT PROVIDE GUIDANCE THAT A PROXIMAL ZTEG (TX2) DEVICE SHOULD BE USED IN COMBINATION WITH AN ALPHA DEVICE. AS PER IFU, THE ZENITH TX2 TAA ENDOVASCULAR GRAFT WITH PRO-FORM IS A TWO-PIECE CYLINDRICAL ENDOVASCULAR GRAFT CONSISTING OF PROXIMAL AND DISTAL COMPONENTS. THE PROXIMAL COMPONENT CAN BE EITHER TAPERED OR NON-TAPERED AND MAY BE USED INDEPENDENTLY (FOR ULCERS/SACCULAR ANEURYSMS) OR IN COMBINATION WITH A DISTAL COMPONENT. AND AS PER SECTION 'ZENITH TX2 TAA ENDOVASCULAR GRAFT WITH PRO-FORM ANCILLARY COMPONENTS', PROXIMAL AND DISTAL MAIN BODY EXTENSIONS CAN BE USED TO PROVIDE ADDITIONAL LENGTH TO THEIR RESPECTIVE PORTIONS OF THE ENDOVASCULAR GRAFT. A CLINICAL ASSESSMENT WAS ALSO PERFORMED FOR THE INVESTIGATION. AS PER ASSESSMENT "THE PATIENT IS UNDOUBTEDLY HEAVILY PREDISPOSED FOR THROMBUS FORMATION THUS IN THE DIFFERENT CLINICAL IMAGING HEAVILY CALCIFICATION OF THE VASCULAR SYSTEM IS SEEN. THE HEAVY CALCIFICATION ALONG WITH THE PATIENT¿S MALIGNANT CONDITION (STOMACH CANCER) AND CURRENT SMOKING THEORETICALLY PLACES THE PATIENT IN THE UPPER EXTREME OF THE SCALE FOR RISK OF THROMBO-EMBOLIC EVENTS INCLUDING FORMATION OF THE CONFIRMED LAMINAR THROMBUS WITHIN THE ENDO-GRAFTS. NO INFORMATION ABOUT THE PATIENT¿S PHARMACOLOGICAL TREATMENT SUCH AS ANTICOAGULANTS, CHOLESTEROL MANAGEMENT, HYPERTENSION TREATMENT ETC. IS AVAILABLE." IT WAS CONCLUDED: "IN CONCLUSION, THERE IS NO INDICATION IN THE AVAILABLE MEDICAL RECORDS, CLINICAL IMAGING ASSESSMENTS ETC. THAT THIS MULTIMORBID PATIENT¿S CONDITION OR TREATMENT WAS IN ANY WAY DETERIORATED OR PROLONGED DUE TO MALFUNCTIONING OR NON-CONFORMING DEVICES. THERE IS NO INFORMATION INDICATIVE OF DEVICE FAILURE." "IT MUST BE STRESSED, THAT ON THE GROUNDS CONSISTING OF THE INFORMATION AVAILABLE IN THE COMPLAINT ONE CANNOT DEFINITIVELY DETERMINE WHETHER THE THROMBUS FORMATION WAS RELATED TO THE DEVICES THEMSELVES OR WAS A RESULT OF THE PATIENT¿S PROGRESSED ATHEROSCLEROTIC STATE AND/OR HEAVY GENERAL PREDISPOSITION FOR THROMBUS FORMATION. NOR CAN ONE CONCLUDE IF THE NEED FOR A RE-INTERVENTION PROCEDURE WAS RELATED TO THE USE OF THE DEVICES OR WOULD HAVE BEEN INDICATED REGARDLESS OF THE KIND OF PRIMARY INTERVENTION CHOSEN." REVIEW OF THE DEVICE HISTORY RECORD FOR THE DEVICE PROVIDED NO INDICATION THAT THE DEVICE WAS PRODUCED OUTSIDE OF SPECIFICATIONS. ARTERIAL OR VENOUS THROMBOSIS IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. BASED ON THE PROVIDED INFORMATION AND REVIEW OF PROVIDED IMAGING, A CAUSE FOR THE THROMBUS FORMATION COULD NOT BE DETERMINED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURERS REF# (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTED TO BE A (B)(6)-YEAR-OLD FEMALE WITH A HISTORY OF PERIPHERAL VASCULAR DISEASE, SIGMADIVERTICULITIS, STOMACH CANCER, TIA (TRANSIENT ISCHEMIC ATTACK), AND SMOKING. THE PRE-PROCEDURE CT SCAN SHOWED A STABLE TYPE III ANEURYSM. THE MAXIMUM THORACOABDOMINAL DIAMETER MEASURED 92 MM. THE CELIAC ARTERY, SMA AND BOTH RENAL ARTERIES WERE PATENT, WITH NO EVIDENCE OF RENAL INFARCTS. ON (B)(6) 2017 THE PATIENT WAS TREATED WITH THE FOLLOWING 6 COOK DEVICES: ZTA-PT-44-40-179, (B)(4) (B)(6) REF: NOT ASSIGNED YET. TBRANCH-34-18-202, (B)(4). ZTEG-2PT-42-32-165-PF, (B)(4), (B)(6) REF: NOT ASSIGNED YET. UNIBODY-22-132 DISTAL BODY (WILLIAM COOK AUSTRALIA), (B)(4). ZSLE-16-74-ZT RIGHT ILIAC LEG GRAFT (COOK INC), (B)(4). ZSLE-20-74-ZT LEFT ILIAC LEG GRAFT (COOK INC), (B)(4). DURING INVESTIGATION FOR THE INITIAL COMPLAINT FOR THIS PATIENT ADDITIONAL FINDING OF MILD TO MODERATE PARTIAL LAMINAR THROMBUS IN ZTEG-2PT-42-32-165-PF HAS BEEN DISCOVERED. CONSEQUENTLY, A NEW COMPLAINT HAS BEEN OPENED (THIS COMPLAINT (B)(4)) TO ADDRESS THIS NEW POTENTIAL FAILURE MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258697 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3623804 10827002236131

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention