BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 10447031 · Received August 25, 2020

    Report

    Report Number
    3002808486-2020-00814
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 17, 2020
    Report Date
    May 17, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATION FINDINGS: A ZTA-P-42-173-W1 WAS USED FOR TEVAR (THORACIC ENDOVASCULAR ANEURYSM REPAIR) IN A 82 YEAR OLD MALE PATIENT. AS PER THE REPORTED INFORMATION THE BLUE ROTATION HANDLE WAS HARDER/STIFFER THAN USUAL. AFTER THE DEVICE HAD BEEN UNSHEATHED, THE GRAFT DEPLOYED AND THE BLUE ROTATION HANDLE HAD BEEN TURNED UNTIL IT STOPPED, THE STENT GRAFT DID NOT SEEM TO BE RELEASED FROM THE INTRODUCTION SYSTEM UNDER FLUOROSCOPY, AND THE PHYSICIAN JUDGED THAT THE RELEASE WIRE HAD NOT DISCONNECTED FROM THE STENT GRAFT. THE PHYSICIAN THEN PERFORMED THE TROUBLESHOOTING MECHANISM OF REMOVING THE BACK-END CAP, REMOVED THE BLUE ROTATION HANDLE AND REMOVED THE RELEASE WIRES, AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. COOK COMPLETED A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE AND THERE WAS NO INDICATION THAT THE DEVICE WAS PRODUCED OUTSIDE OF SPECIFICATIONS. THE IFU STATES THAT IF DIFFICULTIES ARE MET IN REMOVING RELEASE WIRES USE THE STEPS IN TROUBLESHOOTING IN WHICH SURGICAL FORCEPS ARE USED TO PULL THE BACK-END CLIPS OUT AND REMOVE THE BACK-END CAP, SLIDE THE BLUE ROTATION HANDLE BACKWARDS AND PULL THE RELEASE WIRES (WITH SURGICAL FORCEPS IF NEEDED). THE PRODUCT WAS NOT RETURNED FOR EVALUATION DUE TO CONTAGIOUS DISEASE CONTAMINATION. DEVICE EVALUATION MAY HAVE CONTRIBUTED WITH FURTHER INFORMATION FOR THE COMPLAINT INVESTIGATION. BASED ON THE REPORTED INFORMATION IT HAS NOT BEEN POSSIBLE TO ESTABLISH AN EXACT CAUSE FOR THIS EVENT. COOK WILL REOPEN THE INVESTIGATION IF FURTHER INFORMATION OR IMAGES IS RECEIVED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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

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

    Additional Manufacturer Narrative · 1

    MANUFACTURERS REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K) K140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE REPORTED DEVICE WAS INSERTED INTO THE PATIENT'S BODY FOR STENT-GRAFT IMPLANTATION. THE ACCESS WAS GAINED FROM THE LEFT FEMORAL ARTERY. THE PHYSICIAN COMMENTED THAT THE BLUE ROTATION HANDLE WAS HARDER/STIFFER THAN USUAL WHEN THE PHYSICIAN UNSHEATHED THE REPORTED DEVICE, DEPLOYED THE GRAFT, AND TURNED THE BLACK KNOB AND THE BLUE ROTATION HANDLE TO RELEASE THE FIXATION. THE REP TOLD THE DOCTOR TO TURN THE BLUE ROTATION HANDLE UNTIL IT STOPPED, AND IT WAS CONFIRMED THAT THE BLUE ROTATION HANDLE NO LONGER ROTATED. SINCE THE PROFORM-TIE DID NOT SEEM TO BE DISCONNECTED UNDER FLUOROSCOPY, THE PHYSICIAN CAREFULLY PULLED THE GRAY POSITIONER. THEN, THE GRAFT MOVED A LITTLE. CONSEQUENTLY, THE PHYSICIAN JUDGED THAT THE RELEASE WIRE NOT DISCONNECTED AND CANCELLED THE OPERATION. FOLLOWING THE TROUBLESHOOTING INSTRUCTIONS, THE PHYSICIAN PULLED THE BACK-END CLIPS OUT, REMOVED THE BACK-END CAP, AND SLID THE BLUE ROTATION HANDLE BACKWARD. THEN, HE REMOVED THE RELEASE, AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914553 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3874911 10827002449708

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR