BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5976291 · Received September 26, 2016

    Report

    Report Number
    3002808486-2016-01141
    Event Type
    Injury
    Date Received
    September 26, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 5, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # ZTEG-2P-36-202-PF. SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # ZTEG-2P-36-202-PF. PMA 510(K): SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE LIMITED INFORMATION PROVIDED IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE PROXIMAL TYPE 1 ENDOLEAK. AS PER THE IFU ENDOLEAK IS A KNOWN ADVERSE EFFECT. STRICT ADHERENCE TO THE ZENITH TX2 TAA ENDOVASCULAR GRAFT WITH PRO-FORM IFU SIZING GUIDE IS STRONGLY RECOMMENDED, AS SIZING OUTSIDE THE RECOMMENDED RANGE MAY RESULT IN ENDOLEAK. THE IMPLANTED ZTEG PRODUCT IN THIS COMPLAINT FILE WAS A DIFFERENT MAIN BODY GRAFT DIAMETER THAN THE ZTEG PRODUCT INITIALLY INTENDED TO BE IMPLANTED. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) FEMALE PATIENT WITH CHRONIC PHASE OF TYPE B DISSECTION WITH A COMPLICATION UNDERWENT TREATMENT. THE ACCESS VESSEL WAS 9.4MM. THE AORTA ARCH DIDN'T HAVE PROBLEMATIC ANGLE. THE ENTRY OF DISSECTION WAS AT AROUND RIGHT BELOW THE LSA AND COVERING THE LSA AS PLACING THE STENT GRAFT AT ZONE 2 WAS PLANNED. THE USER INSERTED ZTEG-2PT-34-24-199-PF FROM THE LEFT FEMORAL BUT ADVANCEMENT BECAME UNABLE BEFORE THE DELIVERY SYSTEM REACHED THE THORACIC AORTA. THE USER FELT DISCOMFORT ABOUT THIS DEVICE AND DETERMINED IT'S RISKY TO KEEP TRYING, SO HE REMOVED IT AND CHANGED THE PLAN ((B)(4)). HE THEN INSERTED ZTEG-2P-36-202-PF AND PLACED THE STENT GRAFT AT ZONE 2 SUCCESSFULLY. HOWEVER PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED ((B)(4)). SO HE ATTEMPTED TO PLACE ESBE-36-77-T-PF, BUT THE DELIVERY SYSTEM GOT CAUGHT IN THE PREVIOUSLY PLACED STENT GRAFT (ZTEG-2P-36-202-PF) AND WOULD NOT ADVANCE TO THE TARGET SITE ((B)(4)). SO HE REMOVED IT AND BALLOONED THE LEAK SITE INSTEAD. THE LEAK BECAME SMALLER, SO HE DECIDED TO TAKE A WAIT-AND-SEE APPROACH AND COMPLETED THE PROCEDURE. PATIENT OUTCOME: THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) FEMALE PATIENT WITH CHRONIC PHASE OF TYPE B DISSECTION WITH A COMPLICATION UNDERWENT TREATMENT. THE ACCESS VESSEL WAS 9.4MM. THE AORTA ARCH DIDN'T HAVE A PROBLEMATIC ANGLE. THE ENTRY OF DISSECTION WAS AT AROUND RIGHT BELOW THE LSA AND COVERING THE LSA AS PLACING THE STENT GRAFT AT ZONE 2 WAS PLANNED. THE USER INSERTED ZTEG-2PT-34-24-199-PF FROM THE LEFT FEMORAL BUT ADVANCEMENT BECAME UNABLE BEFORE THE DELIVERY SYSTEM REACHED THE THORACIC AORTA. THE USER FELT DISCOMFORT ABOUT THIS DEVICE AND DETERMINED IT TO BE RISKY TO KEEP TRYING, SO HE REMOVED IT AND CHANGED THE PLAN ((B)(4)). HE THEN INSERTED ZTEG-2P-36-202-PF AND PLACED THE STENT GRAFT AT ZONE 2 SUCCESSFULLY. HOWEVER PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED ((B)(4)). SO HE ATTEMPTED TO PLACE ESBE-36-77-T-PF, BUT THE DELIVERY SYSTEM GOT CAUGHT IN THE PREVIOUSLY PLACED STENT GRAFT (ZTEG-2P-36-202-PF) AND WOULD NOT ADVANCE TO THE TARGET SITE ((B)(4)). SO HE REMOVED IT AND BALLOONED THE LEAK SITE INSTEAD. THE LEAK BECAME SMALLER, SO HE DECIDED TO TAKE A WAIT-AND-SEE APPROACH AND COMPLETED THE PROCEDURE. PATIENT OUTCOME: THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629372 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526928

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening