BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 17486657 · Received August 9, 2023

    Report

    Report Number
    2522007-2023-00012
    Event Type
    Death
    Date Received
    August 9, 2023
    Date of Event
    August 1, 2023
    Report Date
    October 31, 2023
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5 ¿ PMA/510(K): K141148. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "INTRAPROCEDURAL DEATHS DURING THE PROCEDURE." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. A RISK ASSESSMENT WILL BE PERFORMED WITHIN THE COMPLAINT SUMMARY TAB OF TRACKWISE. 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.

    Additional Manufacturer Narrative · 0

    G5 ¿ PMA/510(K): K141148. THE EVENT IS CURRENTLY UNDER INVESTIGATION. 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. 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

    MAJOR COMPLICATIONS OCCURRED IN 7 PATIENTS (5.2%). THERE WERE 2 INTRAPROCEDURAL DEATHS DURING THE PROCEDURE. A 71-YEAR-OLD MALE WITH SEVERELY IMPAIRED LEFT VENTRICULAR FUNCTION (LEFT VENTRICULAR EJECTION FRACTION (LVEF), 12%) DIED DURING THE ELECTROMECHANICAL DISSOCIATION AFTER A PARTIAL DEFIBRILLATION LEAD EXTRACTION (<4 CM RESIDUAL LEFT). THE PATIENT WAS IMPLANTED WITH AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) 36 MONTHS BEFORE THE INDEX PROCEDURE. TRANSVENOUS LEAD EXTRACTION (TLE) WAS PERFORMED DUE TO A SYSTEM INFECTION. THE 2ND PATIENT WITH COMPLICATIONS WAS A 71-YEAR-OLD MALE WITH POST-MYOCARDIAL HEART FAILURE (EJECTION FRACTION (EF), 20%) AND A HISTORY OF CORONARY ARTERY BYPASS SURGERY. HE WAS REFERRED FOR TLE DUE TO THE DYSFUNCTION OF THE DEFIBRILLATION LEAD IMPLANTED 9 YEARS BEFORE THE INDEX PROCEDURE. DURING THE PROCEDURE, CARDIAC TAMPONADE OCCURRED AND THE PATIENT DIED DESPITE IMMEDIATE PERICARDIOCENTESIS AND CARDIOSURGICAL INTERVENTION. MINOR COMPLICATIONS (2 PATIENTS, 1.5%) INCLUDED PNEUMOTHORAX (1 PATIENT) AND WORSENING TRICUSPID VALVE INSUFFICIENCY (1 PATIENT). PNEUMOTHORAX OCCURRED IN PATIENTS WHO REQUIRED SUBCLAVIAN VEIN PUNCTURE FOR NEW LEAD IMPLANTATION. THUS, THE COMPLICATION MIGHT BE RELATED TO THIS PROCEDURE AND NOT NECESSARILY TO TLE.

    Description of Event or Problem · 0

    MAJOR COMPLICATIONS OCCURRED IN 7 PATIENTS (5.2%). THERE WERE 2 INTRAPROCEDURAL DEATHS DURING THE PROCEDURE. A 71-YEAR-OLD MALE WITH SEVERELY IMPAIRED LEFT VENTRICULAR FUNCTION (LEFT VENTRICULAR EJECTION FRACTION (LVEF), 12%) DIED DURING THE ELECTROMECHANICAL DISSOCIATION AFTER A PARTIAL DEFIBRILLATION LEAD EXTRACTION (<4 CM RESIDUAL LEFT). THE PATIENT WAS IMPLANTED WITH AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) 36 MONTHS BEFORE THE INDEX PROCEDURE. TRANSVENOUS LEAD EXTRACTION (TLE) WAS PERFORMED DUE TO A SYSTEM INFECTION. THE 2ND PATIENT WITH COMPLICATIONS WAS A 71-YEAR-OLD MALE WITH POST-MYOCARDIAL HEART FAILURE (EJECTION FRACTION (EF), 20%) AND A HISTORY OF CORONARY ARTERY BYPASS SURGERY. HE WAS REFERRED FOR TLE DUE TO THE DYSFUNCTION OF THE DEFIBRILLATION LEAD IMPLANTED 9 YEARS BEFORE THE INDEX PROCEDURE. DURING THE PROCEDURE, CARDIAC TAMPONADE OCCURRED AND THE PATIENT DIED DESPITE IMMEDIATE PERICARDIOCENTESIS AND CARDIOSURGICAL INTERVENTION. MINOR COMPLICATIONS (2 PATIENTS, 1.5%) INCLUDED PNEUMOTHORAX (1 PATIENT) AND WORSENING TRICUSPID VALVE INSUFFICIENCY (1 PATIENT). PNEUMOTHORAX OCCURRED IN PATIENTS WHO REQUIRED SUBCLAVIAN VEIN PUNCTURE FOR NEW LEAD IMPLANTATION. THUS, THE COMPLICATION MIGHT BE RELATED TO THIS PROCEDURE AND NOT NECESSARILY TO TLE. MINOR COMPLICATIONS (2 PATIENTS, 1.5%) INCLUDED PNEUMOTHORAX (1 PATIENT) AND WORSENING TRICUSPID VALVE INSUFFICIENCY (1 PATIENT). PNEUMOTHORAX OCCURRED IN PATIENTS WHO REQUIRED SUBCLAVIAN VEIN PUNCTURE FOR NEW LEAD IMPLANTATION. THUS, THE COMPLICATION MIGHT BE RELATED TO THIS PROCEDURE AND NOT NECESSARILY TO TLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904383 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION DRE COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death