BEUDAMED
    FDA Adverse Event Death Summary report: N

    CMD CODE ONLY THE DEVICE IS MADE UP OF THE BELOW ITEMS

    MDR report key: 10725050 · Received October 23, 2020

    Report

    Report Number
    3002808486-2020-00984
    Event Type
    Death
    Date Received
    October 23, 2020
    Report Date
    February 3, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). INFORMATION INFORMING US THAT THE DEVICE WAS A CMD DEVICE, CMD IS NOT SIMILAR TO ANY DEVICE MARKETED IN US THEREFORE THIS EVENT IS NO LONGER REPORTABLE. 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

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020: TREATMENT OF AORTIC ANEURYSM WHERE THE BRANCHED/ FENESTRATED COMPONENT LANDED IN A PROXIMAL THORACIC COMPONENT. OVER TIME THESE TWO COMPONENTS LATER SEPARATED CAUSING AN ENDOLEAK WHICH LEAD TO A BURST OF THE AORTA.

    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 MARKETED UNDER P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS PATIENT HAD A THREE BRANCH, ONE FENESTRATION DEVICE WITH 30 MM PROXIMAL DIAMETER (B)(4) IN A TAPERED LP THORACIC STENTGRAFT WITH 28 MM DISTAL DIAMETER (B)(4) AT 1 MONTH FOLLOW UP IN (B)(6) 2016 THE OVERLAP WAS AS PLANNED THREE STENTS. IN (B)(6) 2019 THE OVERLAP WAS 2.5 STENTS AND IN 2017 AND 2018 SOMEWHERE IN BETWEEN. A CT PLANNED FOR (B)(6) 2020 WAS DELAYED DUE TO THE COVID SITUATION BUT FINALLY COMPLETED IN (B)(6) 2020 DEMONSTRATING COMPLETE LOSS OF OVERLAP AND AN ENDOLEAK. UNFORTUNATELY A FATAL RUPTURE FOLLOWED SHORTLY AFTER THAT JUST BEFORE A PLANNED REINTERVENTION. THIS CASE DOES RAISE THE QUESTION IF ACTIVE FIXATION WOULD NOT BE PREFERABLE ESPECIALLY WHEN THERE IS ROOM FOR THE STENT GRAFTS TO OVER TIME TAKE A LONGER ROUTE IN THE ANATOMY. PATIENT OUTCOME: PATIENT PASSED AWAY DUE TO RUPTURE PRIOR TO PLANNED REINTERVENTION. THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: AN ADJUNCTIVE PROCEDURE WAS SCHEDULED WITH AN EXTRA INTERMEDIATE PIECE TO CREATE A NEW OVERLAP. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE: DEATH DUE TO ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192223 CMD CODE ONLY THE DEVICE IS MADE UP OF THE BELOW ITEMS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3398914

    Patients

    Seq Age Sex Outcome Treatment
    1 Death