BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 13469302 · Received February 7, 2022

    Report

    Report Number
    3002808486-2022-00065
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    January 24, 2022
    Report Date
    May 2, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REFERENCE# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ON (B)(6) 2022, A PATIENT OF AN UNKNOWN GENDER AND AGE UNDERWENT A TEVAR((THORACIC ENDOVASCULAR AORTIC REPAIR) WITH 1 DEBRANCH IN ZONE 2 WITH TERUMO (BOLTON)'S RELAY PLUS. THE STENT GRAFT WAS PLACED JUST BELOW THE LEFT COMMON CAROTID ARTERY TO TREAT THE ANEURYSM IN THE DISTAL AORTIC ARCH. SINCE AT TYPE 1A ENDOLEAK WAS CONFIRMED, THE PHYSICIAN DECIDED TO PLACE ZTA-DE-38-91-W1 (COMPLAINT DEVICE) IN THE PROXIMAL SIDE ADDITIONALLY. HOWEVER, THE DELIVERY SYSTEM OF THE COMPLAINT DEVICE COULD NOT BE ADVANCED THROUGH THE PREVIOUSLY IMPLANTED RELAY PLUS. THEREFORE, THE ENDOLEAK WAS TREATED BY ADDITIONAL TOUCH-UP WITH GORE'S TRI-LOBE BALLOON. THEN THE ENDOLEAK DECREASED, SO THE PROCEDURE WAS FINISHED AND THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. NO PRODUCT WAS RETURNED AN NO IMAGING WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. BASED ON THE LIMITED PROVIDED FORMATION IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE CAUSE OF THE REPORTED EVENT. COOK WILL REOPEN THE COMPLAINT 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

    ON (B)(6) 2022, A PATIENT UNDERWENT TEVAR WITH 1 DEBRANCH IN ZONE 2 WITH TERUMO (BOLTON)'S RELAY PLUS (38/34-200/ LOT:2104100074). THE STENT GRAFT WAS PLACED JUST BELOW THE LEFT COMMON CAROTID ARTERY TO TREAT THE ANEURYSM IN THE DISTAL AORTIC ARCH. SINCE TYPE 1A ENDOLEAK WAS CONFIRMED, THE PHYSICIAN DECIDED TO PLACE ZTA-DE-38-91-W1/E4196715 IN THE PROXIMAL SIDE ADDITIONALLY. HOWEVER, THE DELIVERY SYSTEM OF THE ZENITH COULD NOT ADVANCE THROUGH THE PREVIOUSLY PLACED RELAY PLUS. THEREFORE, THE ENDOLEAK WAS TREATED BY ADDITIONAL TOUCH-UP WITH GORE'S TRI-LOBE BALLOON, THEN THE ENDOLEAK DECREASED, SO THE PROCEDURE WAS FINISHED AND THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994350 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4196715 10827002449227

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown