BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 7863772 · Received September 11, 2018

    Report

    Report Number
    3001627457-2018-00027
    Event Type
    Injury
    Date Received
    September 11, 2018
    Report Date
    August 20, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENTS REPORTED IN THE LITERATURE FOR THE CDT GROUP WITH EKOS WERE ATTRIBUTED TO THE TPA AND THE PROCEDURE. THE NEW ONSET OF RENAL FAILURE IS LIKELY ATTRIBUTED TO THE CONTRAST MEDIA ASSOCIATED WITH THE PROCEDURE. THE AUTHOR ATTRIBUTED THE ATRIAL FIBRILLATION TO THE PROCEDURE. NO DEVICE MALFUNCTIONS WERE REPORTED. IT SHOULD BE NOTED THAT PE IS A RISK FACTOR FOR ATRIAL FIBRILLATION AND CARDIAC ARRHYTHMIAS ARE LISTED AS A POTENTIAL COMPLICATION IN THE INSTRUCTIONS FOR USE. NO PATIENT OR DEVICE SPECIFIC INFORMATION WAS AVAILABLE FOR THE 11 SUBMASSIVE PE PATIENTS TREATED WITH EKOS BETWEEN OCT 1999 AND MAY 2015 THAT EXPERIENCED ATRIAL FIBRILLATION. NO ADDITIONAL INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED AS A PART OF POST-MARKET SURVEILLANCE AND REPORTED SAFETY OUTCOMES: TITLE: SURGICAL PULMONARY EMBOLECTOMY AND CATHETER-DIRECTED THROMBOLYSIS FOR TREATMENT OF SUBMASSIVE PULMONARY EMBOLISM AUTHORS: AHMED A. KOLKAILAH MD, SAMEER HIRJI MD, GREGORY PIAZZA MD, MS, JULIUS I. EJIOFOR MD, MPH, FERNANDO RAMIREZ DEL VAL MD, MPH, JIYAE LEE BS, SIOBHAN MCGURK BS, SARY F. ARANKI MD, PREM S. SHEKAR MD, TSUYOSHI KANEKO MD FACILITY: HARVARD MEDICAL SCHOOL, BOSTON, MASSACHUSETTS. A REVIEW OF 133 SUBMASSIVE PE PATIENTS BETWEEN OCT 1999 AND MAY 2015 THAT UNDERWENT TREATMENT WITH PULMONARY EMBOLECTOMY (71) OR CDT WITH EKOS (62). OPERATIVE OR PROCEDURAL MORTALITY WAS 5.3% FOR THE ENTIRE COHORT, AND STATISTICALLY SIMILAR BETWEEN THE TWO GROUPS (IE, 7.0% IN THE PULMONARY EMBOLECTOMY GROUP AND 3.1% IN THE CDT GROUP, P = 0.448). THE PRIMARY CAUSE OF DEATH AMONG PATIENTS UNDERGOING PULMONARY EMBOLECTOMY WAS PROGRESSIVE RV FAILURE (100%), WHILE ONE PATIENT DIED OF MASSIVE HEMOTHORAX DUE TO RESPIRATORY FAILURE IN THE CDT GROUP. BLEEDING COMPLICATIONS OCCURRED IN BOTH GROUPS, ALTHOUGH SIGNIFICANTLY HIGHER AMONG PATIENTS IN THE CDT GROUP (9.7%) COMPARED TO THE PULMONARY EMBOLECTOMY COHORT (1.4%, P = 0.025). OF THE SIX CASES (9.7%) WITH BLEEDING COMPLICATIONS IN THE CDT GROUP, ONE PATIENT HAD RECEIVED SYSTEMIC THROMBOLYSIS 2 DAYS BEFORE THE EKOS PROCEDURE AND HAD BLEEDING AT THE RIGHT INTERNAL JUGULAR SITE, WHILE TWO PATIENTS HAD MINOR GROIN AND INCISIONAL (C-SECTION) HEMATOMAS, RESPECTIVELY. ONE PATIENT DEVELOPED HEMOPTYSIS; ANOTHER PATIENT DEVELOPED FRANK MELENA DUE TO A GASTROINTESTINAL MALIGNANCY WITH LIVER METASTASIS, REQUIRING INITIATION OF CHEMOTHERAPY; AND ONE PATIENT HAD A VENTRICULO-PERITONEAL SHUNT AND DEVELOPED INTRACRANIAL HEMORRHAGE, WITH NO FOCAL NEUROLOGICAL DEFICITS, AFTER STARTING HEPARIN. ONE PATIENT (1.4%) IN THE PULMONARY EMBOLECTOMY GROUP DEVELOPED MELENA, THIS PATIENT RECEIVED SYSTEMIC THROMBOLYSIS BEFORE ARRIVING AT OUR INSTITUTION. PATIENTS IN THE CDT GROUP HAD SIGNIFICANTLY LOWER RATES OF NEW ONSET RENAL INSUFFICIENCY (1.6% VS 12.7%) AND ATRIAL FIBRILLATION (17.7% VS 18.3%, ALL P < 0.05). POSTOPERATIVE COMPLICATIONS REPORTED FOR THE CDT GROUP WITH EKOS: DEATH (MASSIVE HEMOTHORAX DUE TO RESPIRATORY FAILURE) (1), ATRIAL FIBRILLATION (11), NEW ONSET OF RENAL FAILURE (1), BLEEDING COMPLICATIONS (6), ICH (1), RECURRENT (IN-HOUSE) PE (1). FOLLOW UP INFORMATION WAS RECEIVED FROM THE CORRESPONDING AUTHOR WITH THE RELATEDNESS OF THE CDT GROUP EVENTS: ONE DEATH (MASSIVE HEMOTHORAX DUE TO RESPIRATORY FAILURE) - TPA RELATED, ELEVEN (11) OCCURRENCES OF ATRIAL FIBRILLATION- PROCEDURE RELATED, ONE NEW ONSET OF RENAL FAILURE - PROCEDURE RELATED, SIX (6) BLEEDING COMPLICATIONS - TPA RELATED, ONE ICH - TPA RELATED, ONE RECURRENT (IN-HOUSE) PE - TPA RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704902 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention