BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 12027209 · Received June 18, 2021

    Report

    Report Number
    2522007-2021-00019
    Event Type
    Death
    Date Received
    June 18, 2021
    Date of Event
    May 26, 2021
    Report Date
    February 25, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    10827002237473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. CONCOMITANT DEVICES: PHILLIPS GLIDELIGHT 14FR AND 16FR. COOK LR-TSS-13.0. PMA/510(K): K141148.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A LEAD EXTRACTION PROCEDURE TO REMOVE THREE LEADS IMPLANTED WITHIN CHEST (RIGHT ATRIUM, RIGHT VENTRICLE, AND LEFT VENTRICLE) BECAUSE IF A BADLY INFECTED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD). THE LEAD EXTRACTION PROCEDURE WAS PERFORMED 2 WEEKS AFTER THE INFECTION WAS CONFIRMED. OF THE LEADS TO BE EXTRACTED, THE LEFT VENTRICULAR WAS EXTRACTED FIRST USING A PHILIPS GLIDELIGHT 14FR. AFTERWARDS, THE RIGHT VENTRICULAR LEAD WAS REMOVED USING THE GLIDELIGHT 14FR, GLIDELIGHT 16FR, AND FINISHED WITH THE COOK EVOLUTION RL 13FR WITH A COOK STEADYSHEATH (LR-TSS-13.0). DURING EXTRACTION OF THE RIGHT VENTRICLE LEAD, A STRONG ADHESION AROUND THE SUPERIOR VENA CAVA (SVC) CURVE WAS NOTED. BOTH GLIDELIGHT LASER SHEATHS WERE UNABLE TO GO THROUGH THE SVC, BUT THE EVOLUTION 13FR AND STEADY SHEATH DID PASS THROUGH THE AREA. BLOOD PRESSURE REPORTEDLY DROPPED AS THE EVOLUTION DEVICE ADVANCED BEYOND THE SVC TOWARDS LEAD TIP. IN RESPONSE TO DROP, PERICARDIOCENTESIS WAS PERFORMED AND AN INTRA-AORTIC BALLOON PUMP WAS EMPLOYED WHILE THE PATIENT WAS PLACED ON A PERCUTANEOUS CARDIOPULMONARY SUPPORT SYSTEM. EXTRACTION WAS THEN RESUMED, WITH ALL THE TARGETED LEADS EXTRACTED COMPLETELY USING EVOLUTION RL 13FR TO COMPLETE THE CASE. DOCTOR NOTED THAT HE WAS NOT SURE WHEN THEY DAMAGED THE VESSEL DURING THE PROCEDURE. AN UPDATE FROM TERRITORY MANAGER REVEALED THAT PATIENT PASSED ON JUNE 1ST DUE TO BACTEREMIA. THE DOCTOR SAID THE REASON OF THE DEATH IS BACTEREMIA AND STATED THAT HE WAS ABLE TO STOP BLEEDING FROM THE SVC DURING THE PROCEDURE. FOR THIS PATIENT, HIS CONDITION AND INFECTION WAS BAD WHEN THE LEAD EXTRACTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920932 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE COOK VANDERGRIFT INC G23747 N173494 10827002237473

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death