BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5586540 · Received April 19, 2016

    Report

    Report Number
    3002808486-2016-00231
    Event Type
    Injury
    Date Received
    April 19, 2016
    Date of Event
    April 1, 2016
    Report Date
    April 4, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002526867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT TIME OF EVENT, DATE OF BIRTH: UNKNOWN AS INFORMATION WAS NOT PROVIDED. WEIGHT: UNKNOWN AS INFORMATION WAS NOT PROVIDED. DEVICE IS SIMILAR TO DEVICE WITH 510(K) P070016. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS SIMILAR TO DEVICE WITH 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE ABOVE LIMITED INFORMATION IT WAS NOT POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THE EXPERIENCED TYPE III ENDOLEAK. IT SHOULD BE MENTIONED THAT THE PHYSICIAN PLACED A BARBED PROXIMAL COMPONENT WITHIN THE DISTAL END OF ANOTHER STENT GRAFT. THIS POSES A RISK OF THE BARBS TO TEAR THE GRAFT MATERIAL AND CONSEQUENTLY CREATE A TYPE III ENDOLEAK. THERE IS NO EVIDENCE TO SUGGEST THAT PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS OR THAT THE IFU WAS INSUFFICIENT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE USER PLANNED TO PLACE ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT FROM THE PROXIMAL ANASTOMOSIS SITE OF THE ARTIFICIAL VESSEL TO RIGHT ABOVE THE CELIAC ARTERY. THE ACCESS VESSEL WAS ALSO REPLACED WITH AN ARTIFICIAL VESSEL BUT MEASURED MORE THAN 8MM, AND THE USER DILATED THE VESSEL USING COOK'S 20FR AND 24FR DILATER IN CASE. THE DELIVERY SYSTEM WAS ADVANCED TO THE TARGET SITE WITHOUT PROBLEM AND THE USER ATTEMPTED TO PULL THE SHEATH TO DEPLOY THE STENT, HOWEVER, THE SHEATH WOULD NOT BE PULLED AT ALL AS IT'S VERY TIGHT. ANOTHER PERSON TRIED TOO, BUT THE SHEATH DIDN'T MOVE AT ALL. THE USER REMOVED THE DELIVERY SYSTEM FROM THE PATIENT AND TRIED TO PULL THE SHEATH, BUT IT STILL DIDN'T MOVE AT ALL. HE GAVE UP ON USING THIS DEVICE AND USED SMALLER ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT (ZTEG-2P-32-200-PF / (B)(4)) INSTEAD. THE USER PLACED ZTEG-2P-32-200-PF / (B)(4) AND THEN HE PLACED ZTEG-2P-38-202-PF DISTALLY WITH LONG OVERLAP AS APPROX HALF LENGTH OF THE STENT GRAFTS. HE DIDN'T PERFORM BALLOONING AT THE JUNCTION OF TWO STENTS WITH CONCERN OVER DAMAGING VESSEL BECAUSE THE PATIENT HAD A DISSECTING ANEURYSM. BALLOONING AT THE DISTAL SIDE WAS PERFORMED. SLIGHT TYPE III ENDOLEAK FROM THE JUNCTION WERE OBSERVED BUT HE TOOK WAIT-AND-SEE APPROACH IN EXPECTATION OF FORMING THROMBUS. PATIENT OUTCOME: THE PATIENT HAS NOT SHOWN PROBLEMATIC SYMPTOMS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE USER PLANNED TO PLACE ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT FROM THE PROXIMAL ANASTOMOSIS SITE OF THE ARTIFICIAL VESSEL TO RIGHT ABOVE THE CELIAC ARTERY. THE ACCESS VESSEL WAS ALSO REPLACED WITH AN ARTIFICIAL VESSEL BUT MEASURED MORE THAN 8MM, AND THE USER DILATED THE VESSEL USING COOK'S 20FR AND 24FR DILATER IN CASE. THE DELIVERY SYSTEM WAS ADVANCED TO THE TARGET SITE WITHOUT PROBLEM AND THE USER ATTEMPTED TO PULL THE SHEATH TO DEPLOY THE STENT, HOWEVER, THE SHEATH WOULD NOT BE PULLED AT ALL AS IT'S VERY TIGHT. ANOTHER PERSON TRIED TOO, BUT THE SHEATH DIDN'T MOVE AT ALL. THE USER REMOVED THE DELIVERY SYSTEM FROM THE PATIENT AND TRIED TO PULL THE SHEATH, BUT IT STILL DIDN'T MOVE AT ALL. HE GAVE UP ON USING THIS DEVICE AND USED SMALLER ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT (ZTEG-2P-32-200-PF / E3275246) INSTEAD. THE USER PLACED ZTEG-2P-32-200-PF / E3275246 AND THEN HE PLACED ZTEG-2P-38-202-PF DISTALLY WITH LONG OVERLAP AS APPROX HALF LENGTH OF THE STENT GRAFTS. HE DIDN'T PERFORM BALLOONING AT THE JUNCTION OF TWO STENTS WITH CONCERN OVER DAMAGING VESSEL BECAUSE THE PATIENT HAD A DISSECTING ANEURYSM. BALLOONING AT THE DISTAL SIDE WAS PERFORMED. SLIGHT TYPE III ENDOLEAK FROM THE JUNCTION WERE OBSERVED BUT HE TOOK WAIT-AND-SEE APPROACH IN EXPECTATION OF FORMING THROMBUS. PATIENT OUTCOME: THE PATIENT HAS NOT SHOWN PROBLEMATIC SYMPTOMS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241448 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE 10827002526867

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening