BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH® DISSECTION ENDOVASCULAR STENT

    MDR report key: 14425276 · Received May 17, 2022

    Report

    Report Number
    3002808486-2022-00322
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Report Date
    December 6, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002342610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE. IT HAS NOT BEEN POSSIBLE TO ESTABLISH A CASUAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IN WHICH NO HARM HAS BEEN REPORTED. THE IMAGING REVIEWER CANNOT CONFIRM THE SEPARATION BUT RATER THINKS IT IS THE FLEXIBILITY OF THE STENT, THAT IS THE REASON, THE 2 LAST STENTS SEEMS DETACHED ON IMAGING. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE CONTROL BEFORE HOSPITAL DISCHARGE, PHYSICIAN HAS NOTICED THAT THE 2 LAST STENT OF ZDES SEEMS DETACHED PATIENT OUTCOME: EVERY PIECES OF THE ENDOGRAFT IS STILL INSIDE THE PATIENT WITHOUT PROBLEMS FOR HIM. PATIENT IS VERY WELL. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    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
    1802100 ZENITH® DISSECTION ENDOVASCULAR STENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4226423 10827002342610

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening