BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6224641 · Received January 5, 2017

    Report

    Report Number
    3002808486-2016-01574
    Event Type
    Injury
    Date Received
    January 5, 2017
    Date of Event
    December 16, 2016
    Report Date
    December 16, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002443225
    Adverse Event
    Yes
    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). A1) UNKNOWN AS INFORMATION WAS NOT PROVIDED. 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: BASED ON THE PROVIDED INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ADVANCEMENT DIFFICULTY. THE REPORTER STATES THAT THE ANATOMY WAS TORTUOUS WHICH CAN BE A CONTRIBUTING FACTOR TO THE REPORTED EVENT. NO EVIDENCE WAS FOUND SUGGESTING THAT THE DEVICE WAS MANUFACTURED OUTSIDE OF SPECIFICATIONS. ACCORDING TO THE SENT IFU, THE USER SHOULD NOT CONTINUE ADVANCING THE INTRODUCTION SYSTEM IF RESISTANCE IS FELT AND ALSO TO INSPECT THE DEVICE PRIOR TO USE IN CASE DAMAGE OCCUR AS A RESULT OF TRANSPORTATION. 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: AN (B)(6) FEMALE PATIENT UNDERWENT ACUTE STAGE OF DAA REPAIR. SEVERE TORTUOUS ANATOMY WAS CONFIRMED IN THE ABDOMINAL AORTA, THE DESCENDING AORTA AND THE AORTA ARCH. THE PHYSICIAN INSERTED THE DELIVERY SYSTEM AND IT COULD PASS THE TORTUOUS PART OF THE ABDOMINAL AORTA AND THE DESCENDING AORTA BUT IT WOULD NOT PASS THE TORTUOUS PART OF THE AORTA ARCH. HE TRIED PULL-THROUGH TECHNIQUE BUT IT STILL WOULD NOT PASS. THE PHYSICIAN DECIDED TO TRY OTHER MANUFACTURER'S DEVICE (BOLTON MEDICAL'S RELAY: 36MM(32MM)-150MMM) AND ORDER IT. UNTIL THE RELAY WAS DELIVERED, THEY HAD TO WAIT FOR AN HOUR. THE RELAY COULD PASS THE TORTUOUS PARTS WITHOUT PROBLEM AND THE STENT GRAFT WAS PLACED TO COVER AN ENTRY AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: ZTEG-2PT-36-157-PF-D 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: AN (B)(6) FEMALE PATIENT UNDERWENT ACUTE STAGE OF DAA REPAIR. SEVERE TORTUOUS ANATOMY WAS CONFIRMED IN THE ABDOMINAL AORTA, THE DESCENDING AORTA AND THE AORTA ARCH. THE PHYSICIAN INSERTED THE DELIVERY SYSTEM AND IT COULD PASS THE TORTUOUS PART OF THE ABDOMINAL AORTA AND THE DESCENDING AORTA BUT IT WOULD NOT PASS THE TORTUOUS PART OF THE AORTA ARCH. HE TRIED PULL-THROUGH TECHNIQUE BUT IT STILL WOULD NOT PASS. THE PHYSICIAN DECIDED TO TRY OTHER MANUFACTURER'S DEVICE (BOLTON MEDICAL'S RELAY: 36 MM( 32 MM)-150 MM) AND ORDER IT. UNTIL THE RELAY WAS DELIVERED, THEY HAD TO WAIT FOR AN HOUR. THE RELAY COULD PASS THE TORTUOUS PARTS WITHOUT PROBLEM AND THE STENT GRAFT WAS PLACED TO COVER AN ENTRY AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7872 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002443225

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention