BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6405307 · Received March 15, 2017

    Report

    Report Number
    3002808486-2017-00834
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    March 7, 2017
    Report Date
    March 7, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527116
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). A4) UNKNOWN AS INFORMATION WAS NOT PROVIDED. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K): P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AS DESCRIBED IN THE DESCRIPTION OF EVENT THE COMPLAINT PRODUCT WAS PLACED IN ZONE 1, WHICH IS DEFINED AS THE TRAILING EDGE OF THE BRACHIOCEPHALIC TRUNK TO THE TRAILING EDGE OF THE LEFT COMMON CAROTID ARTERY. AS PER IFU THE ZENITH TX2 GRAFT IS DESIGNED TO TREAT ANEURYSMS IN THE DESCENDING THORACIC AORTA, AND TO BE PLACED DISTAL TO EITHER THE LEFT SUBCLAVIAN ARTERY OR LEFT COMMON CAROTID ARTERY (IF ADDITIONAL PROXIMAL AORTIC NECK LENGTH ARE REQUIRED), NEVER TO COVERING THE COMMON CAROTID. BASED ON THE INFORMATION AVAILABLE IN THIS COMPLAINT FILE IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED EVENT, AS THE PRODUCT WAS USED OFF-LABEL, TREATING AN AORTIC ARCH ANEURYSM AND PLACED IN ZONE 1. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 76 YEARS-OLD MALE PATIENT UNDERWENT HYBRID TEVAR (TWO DEBRANCH+TEVAR) TO REPAIR OF DISTAL AORTIC ARCH ANEURYSM. THE PATIENT'S ANATOMICAL FORMS WERE NOT SUITABLE; SINCE THERE WAS A TORTUOUS VESSEL WITH THE ACCESS SITE, THE PHYSICIAN SELECTED CIA APPROACH BY OPENING THE ABDOMEN. FIRST, ZTEG-2PT-38-152-PF (E3438212) WAS PLACED FROM ZONE 1 FOLLOWED BY PERFORMED BALLOONING, HOWEVER PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED BY ANGIOGRAPHY (IT WAS EXPECTED BY THE PHYSICIAN)(((B)(4)). SO, TBE-38-77-PF (E3286163) WAS ADDITIONALLY PLACED AT THE PROXIMAL SIDE OF THE MAIN BODY. AFTER PLACEMENT OF THE EXTENSION STENT GRAFT, CONTINUED BLOOD LEAKAGE FROM HEMOSTATIC VALVE OF TBE-38-77-PF WAS OBSERVED DURING REMOVAL OF THE GRAY POSITIONER, OR WHILE INSERTING THE BALLOON DEVICE (GORE/TRI-LOBE BALLOON) FOR TOUCH UP BALLOONING ((B)(4)). TYPE I ENDOLEAK WAS RESOLVED BY ADDED EXTENSION STENT GRAFT AND BALLOONING. AGAINST BLOOD LEAKAGE FROM THE VALVE, ANOTHER DEVICE (GORE/DRY SHEAL SHEATH) WAS USED INSTEAD TO COMPLETE THE PROCEDURE. AMOUNT OF SUCTIONED BLOOD WAS ABOUT 400CC, AND IF THE BLOOD WHICH WAS SOAKED IN THE DRAPE FABRIC INCLUDED, 450~500CC IN TOTAL. PATIENT OUTCOME: THE PATIENT CONDITION IS RECOVERED.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K): P070016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) MALE PATIENT UNDERWENT HYBRID TEVAR (TWO DEBRANCH+TEVAR) TO REPAIR OF DISTAL AORTIC ARCH ANEURYSM. THE PATIENT'S ANATOMICAL FORMS WERE NOT SUITABLE; SINCE THERE WAS A TORTUOUS VESSEL WITH THE ACCESS SITE, THE PHYSICIAN SELECTED CIA APPROACH BY OPENING THE ABDOMEN. FIRST, ZTEG-2PT-38-152-PF (B)(4) WAS PLACED FROM ZONE 1 FOLLOWED BY PERFORMED BALLOONING, HOWEVER PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED BY ANGIOGRAPHY (IT WAS EXPECTED BY THE PHYSICIAN) (B)(4). SO, TBE-38-77-PF (B)(4) WAS ADDITIONALLY PLACED AT THE PROXIMAL SIDE OF THE MAIN BODY. AFTER PLACEMENT OF THE EXTENSION STENT GRAFT, CONTINUED BLOOD LEAKAGE FROM HEMOSTATIC VALVE OF TBE-38-77-PF WAS OBSERVED DURING REMOVAL OF THE GRAY POSITIONER, OR WHILE INSERTING THE BALLOON DEVICE (GORE/TRI-LOBE BALLOON) FOR TOUCH UP BALLOONING (B)(4). TYPE I ENDOLEAK WAS RESOLVED BY ADDED EXTENSION STENT GRAFT AND BALLOONING. AGAINST BLOOD LEAKAGE FROM THE VALVE, ANOTHER DEVICE (GORE/DRY SEAL SHEATH) WAS USED INSTEAD TO COMPLETE THE PROCEDURE. AMOUNT OF SUCTIONED BLOOD WAS ABOUT 400CC, AND IF THE BLOOD WHICH WAS SOAKED IN THE DRAPE FABRIC INCLUDED, 450~500CC IN TOTAL. PATIENT OUTCOME: THE PATIENT CONDITION IS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189185 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527116

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening