BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 8889981 · Received August 13, 2019

    Report

    Report Number
    2522007-2019-00006
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    July 22, 2019
    Report Date
    April 30, 2020
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D2B ¿ PRODUCT CODE: DRE. D11 ¿ CONCOMITANT DEVICES: COOK LIBERATOR® BEACON® TIP LOCKING STYLET (LR-OAF01), AND COOK ONE-TIE® COMPRESSION COIL (LR-OTE-N). G5 ¿ PMA/510(K): K14118. H6 ¿ DEVICE CODE: ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM (2993). H6 ¿ PATIENT CODE DESC 1: VENTRICULAR FIBRILLATION (2130), (LABELED). H6 -- EC METHOD CODE DESC 1: DEVICE NOT ACCESSIBLE FOR TESTING (4117). H6-- EC RESULTS CODE DESC 1: NO FINDINGS AVAILABLE (3221). H6 -- EC CONCLUSIONS CODE DESC 1: CAUSE NOT ESTABLISHED (4315). THIS FOLLOW UP REPORT IS SUBMITTED UPON COMPLETION OF INVESTIGATION. THE INVESTIGATION RESULT ARE AS FOLLOWS: THE DEVICE WAS NOT RETURNED, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE IFU WAS REVIEWED AND LISTED AS A POTENTIAL ADVERSE EVENT IS 'ARRHYTHMIAS AND LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM'. A RISK ASSESSMENT WILL BE COMPLETED PER A QERA 203011.1 AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB OF TRACKWISE FOR THIS COMPLAINT. THIS COMPLAINT FAILURE MODE WILL BE MONITORED PER THE POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESS AT CVI. 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

    THIS COMPLAINT INVOLVES A STUDY PATIENT ENROLLED IN THE RELEASE: TRANSVENOUS LEAD REMOVAL USING THE COOK EVOLUTION® LEAD EXTRACTION SYSTEM POST-MARKET CLINICAL STUDY (PROTOCOL (B)(4), PATIENT (B)(6) ). ON (B)(6) 2019 THE PATIENT HAD 1 IMPLANTED LEAD REMOVED FROM THE RIGHT VENTRICLE DUE TO BACTEREMIA. THE EVOLUTION® RL CONTROLLED-ROTATION DILATOR SHEATH SET, LIBERATOR® BEACON® TIP LOCKING STYLET, AND ONE-TIE® COMPRESSION COIL WERE USED. DURING THE PROCEDURE THE PATIENT DEVELOPED A LIFE-THREATENING ARRHYTHMIA REQUIRING INTERVENTION. INTERVENTION WAS DEFIBRILLATION TWICE. THE SITE INDICATED THIS EVENT IS POSSIBLY RELATED TO BOTH THE STUDY PRODUCT AND THE STUDY PROCEDURE BECAUSE ¿IRRITATION OF THE RIGHT VENTRICULAR MYOCARDIUM BY THE ROTATIONAL SHEATH MAY HAVE CAUSED VENTRICULAR FIBRILLATION.¿ THE PRE-EXISTING CONDITION OF ISCHEMIC CARDIOMYOPATHY WITH AN EJECTION FRACTION OF 20% (SEVERELY DEPRESSED LV FUNCTION) MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. CONCOMITANT DEVICES: COOK LIBERATOR® BEACON® TIP LOCKING STYLET (LR-OAF01), AND COOK ONE-TIE® COMPRESSION COIL (LR-OTE-N). PMA/510(K): K14118. (B)(4). 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 ON (B)(6) 2019 THE PATIENT HAD ONE IMPLANTED LEAD REMOVED FROM THE RIGHT VENTRICLE DUE TO BACTEREMIA. THE EVOLUTION® RL CONTROLLED-ROTATION DILATOR SHEATH SET (LR-EVN-13.0-RL), LIBERATOR® BEACON® TIP LOCKING STYLET (LR-OFA01), AND ONE-TIE® COMPRESSION COIL (LR-OTE-N) WERE USED. DURING THE LEAD EXTRACTION PROCEDURE, THE PATIENT DEVELOPED A LIFE-THREATENING ARRHYTHMIA AND REQUIRED INTERVENTION CONSISTING OF DEFIBRILLATION TWICE. THE PATIENT REMAINS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685007 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention