BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 11939357 · Received June 4, 2021

    Report

    Report Number
    2522007-2021-00018
    Event Type
    Death
    Date Received
    June 4, 2021
    Date of Event
    May 10, 2021
    Report Date
    February 15, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    10827002237466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. PMA/510(K): K141148. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A LEAD EXTRACTION PROCEDURE DUE TO A RECURRENT ICD POCKET INFECTION WITH PERFORATION OF THE POCKET. BEFORE THE LEAD EXTRACTION PROCEDURE WAS STARTED, A TRANSITIONAL PACING LEAD WAS POSITIONED AFTER SEVERAL UNSUCCESSFUL ATTEMPTS. THE PATIENT HAD DIFFICULT ANATOMY, NOTABLY A PERSISTENT VENA CAVA. THE FIRST TARGETED LEAD WAS A FIVE-YEAR-OLD ATRIAL LEAD (MEDTRONIC CAPSUREFIX NOVUS MRI 5076-52). AFTER UNSUCCESSFUL ATTEMPTS TO TURN BACK THE LEADS SCREWED IN CONNECTION TO THE ATRIUM, THE CONNECTOR WAS FINALLY CUT AND A LIBERATOR LOCKING STYLET WAS PLACED. A ONE-TIE COMPRESSION COIL WAS ALSO WRAPPED AROUND THE LEAD. PRODUCTS WORKED AS EXPECTED. EXTRACTION WAS SUCCESSFUL BY PULLING THE ATRIAL LEAD. AT THE TRANSITION TO THE RIGHT VENA BRACHIOCEPHALIC VEIN, A SCREW BECAME BRIEFLY STUCK, THEN THE LEAD SLIPPED OUT EASILY. THE SECOND TARGETED LEAD WAS A FIVE-YEAR-OLD ICD LEAD (MEDTRONIC SPRINT QUATRO S 6935). AFTER UNSUCCESSFUL ATTEMPTS TO TURN BACK THE LEADS SCREWED IN CONNECTION TO THE VENTRICLE, THE CONNECTOR WAS CUT, A LIBERATOR LOCKING STYLET WAS PLACED AND A ONE-TIE COMPRESSION COIL WAS WRAPPED AROUND THE LEAD. PRODUCTS WORKED AS EXPECTED. EXTRACTION WAS SUCCESSFUL BY PULLING THE ICD LEAD. AT THE TRANSITION TO THE RIGHT VENA BRACHIOCEPHALIC VEIN, A SCREW BECAME STUCK BRIEFLY, THEN THE LEAD SLIPPED OUT WITH LIGHT RESISTANCE. THE THIRD TARGETED LEAD WAS A 26-YEAR-OLD LV LEAD (MEDTRONIC CAPSURE SP 4024). THE CONNECTOR WAS CUT, LIBERATOR LOCKING STYLET WAS PLACED, AND A ONE-TIE COMPRESSION COIL WAS WRAPPED AROUND THE LEAD. PRODUCTS WORKED AS EXPECTED. AFTER LIGHT PULLING, A MEDIASTINAL SHIFT INDICATED STRONG ADHESIONS OF THE LV LEAD TO DIFFERENT PARTS OF THE SVC. FOR THE NEXT STEP OF THE EXTRACTION, AN EVOLUTION 11F RL WAS USED. IN ORDER TO PROVIDE BETTER FLEXIBILITY, THE SHEATHS OF THE EVOLUTION RL WERE NOT USED. ENTRANCE TO THE SUBCLAVIAN VEIN WAS EXTREMELY DIFFICULT BECAUSE OF STRONG SCAR TISSUE IN THE POCKET. THE PASSING OF THE RIGHT VENA BRACHIOCEPHALIC VEIN WAS UNEXPECTEDLY EASY, BUT AFTER THE ENTRANCE INTO THE SVC THE LEAD WAS FIRMLY CONNECTED TO THE VEIN WALL. SINCE THE CURVE OF THE SVC WAS PASSED, THE TIP OF THE EVOLUTION RL WAS ALWAYS IN PERFECT ALIGNMENT TO THE LEAD. AFTER A STRENUOUS PERIOD OF VERY SLOW ADVANCEMENT AND DIFFERENT PULLBACKS AND RESTARTS OF THE TREATMENT, THE EVOLUTION PASSED THE ADHESION WITHOUT ANY OBVIOUS ISSUES. THE LEAD SLIPPED INTO THE EVOLUTION EASILY AND THE PULL-BACK OF THE TOOL WAS EASY AS WELL. AFTER EXAMINING THE LEAD FOR ITS INTEGRITY NO DEFECTS WERE NOTED. AS EXPECTED, SOME PASSAGES EXHIBITED AREAS OF HEAVY ADHESIONS. SOME MINUTES LATER THE BLOOD PRESSURE FELL, AND PATIENT NEEDED REANIMATION WHICH WAS ULTIMATELY UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838929 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC G23746 N177801 10827002237466

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death LR-OFA01| LR-OTE-N| LR-OFA01| LR-OTE-N