BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    MDR report key: 7395040 · Received April 4, 2018

    Report

    Report Number
    3002808486-2018-00397
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    March 15, 2018
    Report Date
    June 26, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002448725
    Adverse Event
    Yes
    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. 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). MANUFACTURER REF# PR221264. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI). 400 DANIELS WAY. BLOOMINGTON, IN 47404. REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: AS PER THE REPORTED INFORMATION, WHEN THE PHYSICIAN RELEASED THE TRIGGER WIRES FROM THE SYSTEM, THE BARE STENT WAS DEPLOYED BENT AT APPROXIMATELY 90 DEGREES TOWARDS THE INNER AORTIC CURVATURE. THE REPORTED ISSUE WAS CORRECTED USING A BALLOON CATHETER. ACCORDING TO THE REPORTED INFORMATION, THERE WERE NOT OBSERVED ANY ADVERSE EFFECTS TO THE PATIENT WHO HAD SUITABLE ANATOMY FOR THE PROCEDURE. IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OR A LIKELY CAUSE OF THE REPORTED EVENT AS NO IMAGING WAS PROVIDED. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. 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) YEAR OLD MALE PATIENT UNDERWENT TAA REPAIR. THE PATIENTS ANATOMICAL FORMS WERE SUITABLE FOR THE PROCEDURE. TWO DEVICES WERE USED FOR THE PROCEDURE: ZTA-PT-44-40-179-W1 / E3682927 (ZONE 4). ZTA-DE-34-112-W1 / E3677362 (ZONE 2). WHEN THE PHYSICIAN RELEASED THE TRIGGER WIRE OF ZTA-PT-44-40-179-W1, THE BARE STENT WAS DEPLOYED BENT AT APPROXIMATELY 90 DEGREES AGAINST LESSER CURVATURE OF THE VESSEL WALL AS IF IT WAS STICKING IN THE VESSEL (VESSEL PERFORATION DID NOT OCCUR.). HE MANAGED TO FIX THE BENT USING A BALLOON CATHETER. THE PHYSICIAN PERFORMED SEVEN CASES WITH USING ZTA- PRODUCT, AND THIS WAS THE FIRST CASE TO USE ZTA- PRODUCT WITH 'PRO-FORM TIE'. REGARDING SEVEN CASES SO FAR, THERE WAS NO EXPERIENCE WITH THE SAME OCCURRENCE SUCH AS ¿THE BARE STENT WAS DEPLOYED BENT AT 90 DEGREES¿. REGARDING TRIGGER WIRE REMOVAL, THE BLUE ROTATION HANDLE WAS TURNED MORE PROPERLY THAN BEFORE, HOWEVER, THERE WAS NO HELP. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AN 88 YEAR OLD MALE PATIENT UNDERWENT TAA REPAIR. THE PATIENTS ANATOMICAL FORMS WERE SUITABLE FOR THE PROCEDURE. TWO DEVICES WERE USED FOR THE PROCEDURE: ZTA-PT-44-40-179-W1 / E3682927 (ZONE 4). ZTA-DE-34-112-W1 / E3677362 (ZONE 2). WHEN THE PHYSICIAN RELEASED THE TRIGGER WIRE OF ZTA-PT-44-40-179-W1, THE BARE STENT WAS DEPLOYED BENT AT APPROXIMATELY 90 DEGREES AGAINST LESSER CURVATURE OF THE VESSEL WALL AS IF IT WAS STICKING IN THE VESSEL (*VESSEL PERFORATION DID NOT OCCUR.). HE MANAGED TO FIX THE BENT USING A BALLOON CATHETER. THE PHYSICIAN PERFORMED SEVEN CASES WITH USING ZTA- PRODUCT, AND THIS WAS THE FIRST CASE TO USE ZTA- PRODUCT WITH 'PRO-FORM TIE'. REGARDING SEVEN CASES SO FAR, THERE WAS NO EXPERIENCE WITH THE SAME OCCURRENCE SUCH AS ¿THE BARE STENT WAS DEPLOYED BENT AT 90 DEGREES¿. REGARDING TRIGGER WIRE REMOVAL, THE BLUE ROTATION HANDLE WAS TURNED MORE PROPERLY THAN BEFORE, HOWEVER, THERE WAS NO HELP. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239293 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3682927 10827002448725

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening