BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH DISSECTION ENDOVASCULAR STENT

    MDR report key: 21663050 · Received March 21, 2025

    Report

    Report Number
    3002808486-2025-00058
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 27, 2025
    Report Date
    July 16, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    00827002474956
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). H6) F28 - APPROPRIATE HEALTH IMPACT TERM/CODE NOT AVAILABLE: F1910 - CANCELLED/ABORTED SURGICAL PROCEDURE. AFTER INVESTIGATION THE EVENT FOR THIS CN# IS NO LONGER REPORTABLE AS NOTHING INDICATES DEVICE MALFUNCTION. SUMMARY OF INVESTIGATIONAL FINDINGS: A ZDES-46-120-US (COMPLAINT DEVICE) WAS GOING TO BE THE SECOND DEVICE IMPLANTED TO EXTEND THE TREATMENT AREA. THE FIRST ZDES WAS PLACED PROXIMALLY. THE SECOND DEVICE WOULD NOT ADVANCE THROUGH THE FIRST STENT. THE TIP AND SHEATH KEPT GETTING HUNG UP. THE PHYSICIAN DID NOT WANT TO DAMAGE THE EXISTING STENT. FURTHER INFORMATION COULD NOT BE PROVIDED, AND IT IS THEREFORE ASSUMED THAT THE PROCEDURE WAS ABORTED. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. BASED ON THE LIMITED INFORMATION AND NO DEVICE AVAILABLE FOR EVALUATION, THE EXACT CAUSE FOR WHY THE COMPLAINT DEVICE COULD NOT PASS THE PREVIOUSLY IMPLANTED ZDES COULD NOT BE DETERMINED. PASSING A STENT IN A PROBABLY SLIGHTLY CURVED AREA MAY CAUSE THE INTRODUCTION SYSTEM TIP TO GET CAUGHT ON STENT SEGMENTS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) PMA/510(K): P180001 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 DEVICE WAS GOING TO BE THE SECOND DEVICE IMPLANTED TO EXTEND TREATMENT AREA. THE FIRST ZDES WAS PLACED PROXIMAL. THE SENCOND DEVICE WOULD NOT ADVANCE THROUGH THE FIRST STENT. THE TIP AND SHEATH KEPT GETTING HUNG UP. PHYSICIAN DID NOT WANT TO DAMAGE THE EXISTING STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689853 ZENITH DISSECTION ENDOVASCULAR STENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G47495 E4633488 00827002474956

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female