BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 8123845 · Received December 3, 2018

    Report

    Report Number
    3002808486-2018-01399
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 10, 2018
    Report Date
    November 7, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A ZTA-DE-34-112-W1 DEVICE WAS USED TO TREAT A PROXIMAL TYPE 1 ENDOLEAK AFTER PLACING TWO STENT GRAFTS FROM ANOTHER MANUFACTURER. HOWEVER, RESISTANCE WAS ENCOUNTERED WHEN REACHING THE AREA BETWEEN THE COMMON ILIAC ARTERY AND THE EXTERNAL ILIAC ARTERY. MINIMUM DIAMETER OF THE ACCESS ROUTE WAS REPORTED TO BE 7.5MM. THE DEVICE WAS REMOVED, AND BALLOONING OF THE LESION WAS PERFORMED SEVERAL TIMES. ALTHOUGH A SLIGHT ENDOLEAK REMAINED THE PHYSICIAN JUDGED THAT THE ENDOLEAK WOULD DIMINISH ONCE HEPARIN WAS NEUTURALIZED AND THUS, DETERMINED TO END THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED. ADDITIONAL COMMENT FROM THE PHYSICIAN EXPLAINS THAT THERE WAS NO PROBLEMS IN THE DIAMETER OF THE ACCESS ROUTE WHEN IT WAS ASSESSED PRIOR TO THE PROCEDURE AND THAT SPASM MIGHT HAVE OCCURRED. THE COMPLAINT DEVICE WAS RETURNED FOR THE INVESTIGATION. THE STENT GRAFT HAD BEEN DEPLOYED AND WAS RETURNED AS WELL. THE INTRODUCTION SYSTEM WAS RETURNED IN A SMALL SHIPPING BOX, AND WAS BENT ON THE MIDDLE (SHEATH) TO FIT IN THE BOX. THE DEVICE COMPONENTS WERE INSPECTED VISUALLY AND IN MICROSCOPE. NO DEFECTS WERE FOUND. THE DILATOR TIP AND THE SHEATH SHOWED NO SIGNS OF DAMAGE AND WAS NOT FRAYED IN THE ENDS. THE OUTER DIAMETER ON THE SHEATH WAS MEASURED WITH A VERNIER CALIPER AND WAS WITHIN SPECIFICATION. ACCORDING TO THE DESCRIPTION OF EVENT THE OUTER SHEATH DIAMETER (7.1MM) WAS SUITABLE FOR THE MINIMUM DIAMETER OF THE ACCESS ROUTE (7.5MM) MEASURED PRIOR TO THE PROCEDURE. IT IS LIKELY THAT SPASM CONTRIBUTED TO THE ADVANCEMENT DIFFICULTY, AS SUGGESTED BY THE PHYSICIAN, HOWEVER AN EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED BASED ON THE PROVIDED INFORMATION AND PRODUCT EVALUATION. 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.

    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) SIMILAR TO DEVICES UNDER PMA/510(K) P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 75 YEARS OLD FEMALE PATIENT UNDERWENT TAA. PATIENT¿S ANATOMY WAS SUITABLE FOR THE PROCEDURE (THE MINIMUM DIAMETER OF THE ACCESS ROUTE WAS 7.5MM). RIGHT FEMORAL APPROACH WAS SELECTED. A STENT GRAFT WAS PLACED IN THE AORTA FIRST AND THEN, A SECOND STENT GRAFT, BOTH FROM A DIFFERENT MANUFACTURER, WAS IMPLANTED PROXIMAL TO THE STENTGRAFT. AFTER THAT, CONFIRMATORY ANGIOGRAPHY WAS PERFORMED, WHICH REVEALED A SLIGHT PROXIMAL TYPE 1 ENDOLEAK. THEREFORE, A THIRD STENT GRAFT, ALSO FROM A DIFFERENT MANUFACTURER, WAS USED TO TREAT THE ENDOLEAK, BUT ITS DELIVERY SYSTEM STOPPED ADVANCING ON THE WAY AND COULD NOT BE MADE TO REACH THE LESION. SO, THE COMPLAINT DEVICE ZTA-DE-34-112-W1 WHOSE DELIVERY SYSTEM¿S DIAMETER WAS SMALLER THAN THAT OF THE THIRD DEVICE WAS USED INSTEAD. HOWEVER, RESISTANCE WAS ENCOUNTERED ALSO DURING THE ADVANCEMENT OF THE ZTA-DE-34-112-W1 DELIVERY SYSTEM. ACCORDING TO THE MEASUREMENT PRIOR TO THE PROCEDURE, THERE WERE NO PROBLEMS IN THE DIAMETER OF THE ACCESS ROUTE AND ALSO, THE DELIVERY SYSTEM OF ANOTHER DEVICE WITH LARGER DIAMETER DID REACH THE LESION. CONSIDERING ABOVE, THE DELIVERY SYSTEM OF ZTA-DE-34-112-W1 WAS PRESUMED TO BE ABLE TO REACH THE LESION WITHOUT PROBLEMS, BUT IT DID NOT. IT WAS RETRIEVED OUT OF THE PATIENT AND THEN, BALLOONING OF THE LESION WAS PERFORMED SEVERAL TIMES. ALTHOUGH SLIGHT ENDOLEAK REMAINED, THE PHYSICIAN JUDGED THAT THE ENDOLEAK WOULD DIMINISH ONCE HEPARIN HAD GOT NEUTRALIZED AFTERWARD AND THUS, DETERMINED TO FINISH THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018: THE RESISTANCE WAS FELT WHEN THE TIP OF THE DELIVERY SYSTEM WAS IN THE AREA BETWEEN THE COMMON ILIAC ARTERY AND THE EXTERNAL ILIAC ARTERY, MEANING BEFORE REACHING THE STENT GRAFT ALREADY IN PLACE. THE ZTA-DE WAS INTENDED TO BE DEPLOYED IN THE ZONE 4 AORTA ZONE. PATIENT OUTCOME: NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963340 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3753050 10827002449180

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR