BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 7760929 · Received August 8, 2018

    Report

    Report Number
    3002808486-2018-00883
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    July 13, 2018
    Report Date
    November 15, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449548
    Product Problem
    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). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) DEVICE IS SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI). 400 DANIELS WAY. BLOOMINGTON, IN 47404. REGISTRATION NO.: 3005580113. H11) CORRECTED DATA: B5) DESCRIPTION OF EVENT. DEVICE RPN HAVE BEEN UPDATED. INVESTIGATION IS STILL IN PROGRESS. 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 (B)(6) FEMALE PATIENT UNDERWENT TAA REPAIR. THE ACCESS VESSEL WAS PARTIALLY NARROWED AND THE AORTA WAS PARTIALLY TORTUOUS, BUT THE PHYSICIAN DETERMINED THAT DELIVERY SYSTEMS WOULD BE ADVANCED. THE TREATMENT AREA WAS LONG. ZTA-P-34-209-W1 WAS PLACED FROM RIGHT BELOW THE LEFT SUBCLAVIAN ARTERY, AND THEN ZTA-D-34-190-W1 WAS PLACED WITH APPROX 3 STENS AND PROXIMAL BARE STENT OVERLAPPING. THE OVERLAP WAS SLIGHTLY SHORT BECAUSE THE PHYSICIAN GAVE PRIORITY TO THE DISTAL LANDING POINT. AFTER BALLOONING WAS PERFORMED, ENDOLEAK THAT WAS SEEMED TO BE TYPE IV AND/OR TYPE III WAS CONFIRMED, SO ADDITIONAL BALLOONING WAS PERFORMED. HOWEVER, THE ENDOLEAK WAS NOT SOLVED, SO THE PHYSICIAN DECIDED TO PLACE ZTA-P-34-161-W1 TO COVER THE JUNCTION AND AS MANY PART OF ZTA-P-34-209-W1. ((B)(4)) HE INSERTED THE DELIVERY SYSTEM OF ZTA-P-34-209-W1 FROM THE RIGHT FEMORAL BUT COULD NOT ADVANCE TO THE TARGET SITE. IT COULD BE DUE TO INTERFERENCE OF PREVIOUSLY PLACED STENT GRAFTS. HE TRIED TO ADVANCE IT FROM THE LEFT FEMORAL BUT FAILED. HE FELT STRONG RESISTANCE AS IF IT GOT CAUGHT WITH SOMETHING, SO HE REMOVED IT FROM THE PATIENT AND FOUND THE DEVICE TIP WAS FRAYED. HE GAVE UP ON USING THIS DEVICE TO AVOID THE RISK OF VESSEL DAMAGE. ((B)(4)). ZTA-DE-34-112-W1 WAS USED INSTEAD AND THE STENT GRAFT WAS PLACED SUCCESSFULLY TO COVER THE JUNCTION AND AS MANY PART OF ZTA-P-34-209-W1. HE CONFIRMED THAT THE ENDOLEAK WAS SOLVED AND COMPLETED THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS DUE TO THIS OCCURRENCE AND IS DOING FINE AFTER THE PROCEDURE.

    Description of Event or Problem · 0

    UPDATED DEVICE RPN IN DESCRIPTION OF EVENT: A 72 YEAR OLD FEMALE PATIENT UNDERWENT TAA REPAIR. THE ACCESS VESSEL WAS PARTIALLY NARROWED AND THE AORTA WAS PARTIALLY TORTUOUS, BUT THE PHYSICIAN DETERMINED THAT DELIVERY SYSTEMS WOULD BE ADVANCED. THE TREATMENT AREA WAS LONG. ZTA-P-34-209-W1 WAS PLACED FROM RIGHT BELOW THE LEFT SUBCLAVIAN ARTERY, AND THEN ZTA-D-34-190-W1 WAS PLACED WITH APPROX 3 STENS AND PROXIMAL BARE STENT OVERLAPPING. THE OVERLAP WAS SLIGHTLY SHORT BECAUSE THE PHYSICIAN GAVE PRIORITY TO THE DISTAL LANDING POINT. AFTER BALLOONING WAS PERFORMED, ENDOLEAK THAT WAS SEEMED TO BE TYPE IV AND/OR TYPE III WAS CONFIRMED, SO ADDITIONAL BALLOONING WAS PERFORMED. HOWEVER, THE ENDOLEAK WAS NOT SOLVED, SO THE PHYSICIAN DECIDED TO PLACE ZTA-P-34-161-W1 TO COVER THE JUNCTION AND AS MANY PART OF ZTA-P-34-209-W1. (B)(4). HE INSERTED THE DELIVERY SYSTEM OF ZTA-P-34-161-W1 FROM THE RIGHT FEMORAL BUT COULD NOT ADVANCE TO THE TARGET SITE. IT COULD BE DUE TO INTERFERENCE OF PREVIOUSLY PLACED STENT GRAFTS. HE TRIED TO ADVANCE IT FROM THE LEFT FEMORAL BUT FAILED. HE FELT STRONG RESISTANCE AS IF IT GOT CAUGHT WITH SOMETHING, SO HE REMOVED IT FROM THE PATIENT AND FOUND THE DEVICE TIP WAS FRAYED. HE GAVE UP ON USING THIS DEVICE TO AVOID THE RISK OF VESSEL DAMAGE. (B)(4). ZTA-DE-34-112-W1 WAS USED INSTEAD AND THE STENT GRAFT WAS PLACED SUCCESSFULLY TO COVER THE JUNCTION AND AS MANY PART OF ZTA-P-34-209-W1. HE CONFIRMED THAT THE ENDOLEAK WAS SOLVED AND COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606953 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3678461 10827002449548

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR