BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 11371194 · Received February 24, 2021

    Report

    Report Number
    3002808486-2021-00149
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    February 17, 2021
    Report Date
    June 22, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#(B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ON (B)(6) 2021, A FEMALE PATIENT UNDERWENT TEVAR WITH THE INDICATION ULCER AND INTRAMURALT HEMATOMA. A ZTA-PT-34-30-161-W1 WAS INSERTED FROM THE RIGHT FEMORAL ARTERY AND THE PROXIMAL END OF THE ZTA-PT DEVICE WAS PLACED RIGHT BEFORE THE LCCA, BUT COVERED LSA. PER THE REQUESTED CLARIFICATION THE PROXIMAL SEAL ZONE LENGTH WAS 28MM AND DIAMETER 30MM, AND CALCIFICATION WAS OBSERVED IN THE PROXIMAL SEAL ZONE. AFTER THE STENT GRAFT WAS PLACED, PROXIMAL TYPE 1 ENDOLEAK WAS CONFIRMED ((B)(4)). ACCORDING TO THE PHYSICIAN THE POSSIBLE CAUSE FOR THE ENDOLEAK WAS DUE TO CALCIFICATION IN THE PROXIMAL SEAL ZONE. TO TREAT THE PROXIMAL TYPE 1 ENDOLEAK, THE PHYSICIAN TRIED TO INSERT ZTA-DE-34-112-W1 (COMPLAINT DEVICE) BUT IT WOULD NOT PASS THROUGH THE LUMEN OF THE PREVIOUSLY PLACED ZTA-PT DEVICE. PER THE REQUESTED CLARIFICATION THE ZTA-DE DEVICE WAS PLANNED TO LAND IN ZONE 2 TO COVER THE PROXIMAL ENDOLEAK. THE PHYSICIAN DECIDED NOT TO TRY ANOTHER DEVICE BUT TAKE THE WAIT-AND-SEE APPROACH AND COMPLETED THE PROCEDURE. NO ADVERSE EFFECTS ON THE PATIENT WAS REPORTED AND THE PHYSICIAN CONFIRMED BY FOLLOW UP CT THAT THE ENDOLEAK WAS GONE. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT ALL DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE RELEASE. THE DEVICE WAS NOT RETURNED, AND NO IMAGES WAS PROVIDED. A DRAWING REPRESENTING THE PRE-PROCEDURE SCHEMA WAS PROVIDED AND PER THE REQUESTED CLARIFICATION THE DRAWING SHOWS CALCIFICATION IN THE PROXIMAL LANDING/SEAL ZONE WHICH MOST LIKELY LED TO TYPE 1A ENDOLEAK. THE ZTA-DE DEVICE WAS PLANNED TO LAND IN ZONE 2 TO TREAT THE PROXIMAL ENDOLEAK. BASED ON THE AVAILABLE INFORMATION IN THIS COMPLAINT IT IS NOT POSSIBLE TO ESTABLISH AN EXACT CAUSE OF THE EVENT BUT THE INSTRUCTIONS FOR USE, SHIPPED WITH THIS TYPE OF DEVICE, STATES: DISTAL EXTENSIONS CAN BE USED TO PROVIDE ADDITIONAL LENGTH TO THE ENDOVASCULAR GRAFT DISTALLY OR TO INCREASE THE LENGTH OF OVERLAP BETWEEN COMPONENTS. ADDITIONAL PROXIMAL COMPONENTS MAY BE USED TO EXTEND GRAFT COVERAGE PROXIMALLY. COOK WILL REOPEN THE INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. 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

    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 UNDER P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A FEMALE PATIENT UNDERWENT A REPAIR OF ANEURYSM IN THE DISTAL AORTA ARCH. ZTA-PT-34-30-161-W1 (E4004073) WAS INSERTED FROM THE RIGHT FEMORAL AND THE STENT GRAFT WAS PLACED. THEN THE USER INSERTED THE DELIVERY SYSTEM OF ZTA-DE-34-112-W1 (E4045770) BUT IT WOULD NOT PASS THROUGH THE LUMEN OF THE PREVIOUSLY PLACED STENT GRAFT (ZTA-PT-34-30-161-W1 - E4004073). THE USER DECIDED NOT TO TRY THE DIFFERENT DEVICE AND TAKE WAIT-AND-SEE APPROACH AND COMPLETED THE PROCEDURE. 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
    270770 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4045770 10827002449180

    Patients

    Seq Age Sex Outcome Treatment
    1