BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 22456516 · Received July 9, 2025

    Report

    Report Number
    3002808486-2025-00144
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    July 3, 2025
    Report Date
    December 22, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF# (B)(4) SUMMARY OF INVESTIGATIONAL FINDINGS: THE USER ATTEMPTED TO ADD A ZTA-DE-34-112-W1 (COMPLAINT DEVICE) TO THE DISTAL OF A TERUMO/RELAY PRO THAT HAD BEEN IMPLANTED BEFOREHAND FROM THE AORTIC ARCH TO THE DESCENDING AORTA. HOWEVER, THE ZTA-DE-34-112-W1 COULD NOT REACH THE TARGET LOCATION. THERE WAS NO ENDOLEAK NOTED, THEREFORE, THE USER FINISHED THE PROCEDURE WITHOUT ADDITIONAL PROCEDURE. NO PATIENT HEALTH HAZARDS WERE REPORTED. THE LOCATION OF THE ADVANCEMENT DIFFICULTY WAS IN A PREVIOUSLY IMPLANTED STENT GRAFT TERUMO. THE PATIENT´S ANATOMY IN THE AREA OF THE DIFFICULTY WAS REPORTED AS TORTUOUS. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR SALES REPRESENTATIVE TESTIMONY. THE ENTIRE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE EVALUATION DETERMINED THE FOLLOWING: NO NONCONFORMANCES WERE OBSERVED ON THE DILATOR TIP, TIP OF THE SHEATH OR SHEATH DURING DEVICE EVALUATION. THE OD (OUTER DIAMETER) OF THE SHEATH WAS MEASURED TO BE SMALLER 0.0712MM (JUST BELOW THE MINIMUM SPECIFIED MEASUREMENT OF OUTER DIAMETER) THAN SPECIFIED BUT MEASURED WITH OTHER EQUIPMENT THAN SPECIFIED. SINCE THE OD WAS MEASURED SMALLER THAN SPECIFIED, IT SEEMS REASONABLE TO BELIEVE THAT ADVANCEMENT INABILITY WAS NOT CAUSED BY A NONCONFORMING SHEATH WITH SMALLER OD. NO ACTION IS INITIATED CURRENTLY. AN IMAGE WAS REQUESTED BUT NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR LABEL. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. 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

    MANUFACTURERS REF # (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016 INVESTIGATION IS STILL IN PROGRESS. 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE USER ATTEMPTED TO ADD A ZTA-DE-34-112-W1 TO THE DISTAL OF A TERUMO/RELAYPRO (AR-B3225028) THAT HAD BEEN IMPLANTED BEFOREHAND FROM THE AORTIC ARCH TO THE DESCENDING AORTA. HOWEVER, THE ZTA-DE-34-112-W1 COULD NOT REACH THE TARGET LOCATION. THERE WAS NO END LEAK NOTED, THEREFORE, THE USER FINISHED THE PROCEDURE WITHOUT ADDITIONAL PROCEDURE. THE USER SUSPECT THERE IS A STRUCTURAL PROBLEM WITH THE TIP. PATIENT OUTCOME: NO PATIENT HEALTH HAZARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702609 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G44918 E4529442 10827002449180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown