BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 7795201 · Received August 17, 2018

    Report

    Report Number
    3001627457-2018-00024
    Event Type
    Death
    Date Received
    August 17, 2018
    Date of Event
    July 21, 2014
    Report Date
    July 20, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006134
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT DATABASE CONFIRMED THAT THIS PATIENT DEATH WAS NOT REPORTED TO EKOS BY THE TREATING PHYSICIAN AT THE TIME OF THE EVENT IN 2014. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION AND MET ALL ACCEPTANCE CRITERIA PRIOR TO RELEASE. THE BASELINE STATUS OF THIS PATIENT LIKELY INDICATES THAT THE PATIENT'S PRE-TREATMENT CONDITION WAS A FACTOR IN THIS OUTCOME. NO DEVICE MALFUNCTION WAS REPORTED. THIS PATIENT LIKELY SUFFERED A PROGRESSION OF A MASSIVE PE DURING EKOS TREATMENT. THE INVESTIGATOR WAS UNABLE TO ESTABLISH A CAUSE FOR THIS PATIENT'S DEATH DURING THE RETROSPECTIVE REVIEW OF THIS PATIENT'S CHART.

    Additional Manufacturer Narrative · 1

    AN UPDATED ASSESSMENT WAS RECEIVED FROM THE PRINCIPLE INVESTIGATOR ON 23 AUG 2018. THE CAUSE OF DEATH FOR THIS SUBJECT WAS A MASSIVE PULMONARY EMBOLISM. THIS DEATH WAS NOT RELATED TO THE EKOS DEVICE.

    Description of Event or Problem · 1

    SUBJECT (B)(6) IS A (B)(6) YEAR OLD FEMALE PATIENT ENROLLED IN THE RETROSPECTIVE CLINICAL STUDY REGISTRY (B)(6). THIS PATIENT HAD A BMI OF 38.1 AND AN ABNORMAL BASELINE OF SINUS TACHYCARDIA; MARKED RIGHT AXIS DEVIATION; RIGHT BUNDLE BRANCH BLOCK; MARKED ST DEPRESSION, CONSIDER [POSSIBLE] SUBENDOCARDIAL INJURY. THE ONSET DATE OF THE PULMONARY EMBOLISM (PE) SYMPTOMS WAS (B)(6) 2014 AND CONSISTED OF TACHYCARDIA, HYPOXEMIA, PROLONGED HYPOTENSION (GREATER THAN 15 MINS), REQUIRED PRESSORS TO MAINTAIN ADEQUATE SYSTOLIC PRESSURE, SYNCOPE (FAINTING), SUDDEN PERIOD OF CONFUSION, AND LETHARGY. NO OTHER INTERVENTIONAL PROCEDURES FOR THE PE WERE ATTEMPTED BEFORE PLACING THE EKOS CATHETERS. TWO EKOS DEVICES (SERIAL # (B)(4) IN THE LEFT PULMONARY ARTERY AND SERIAL # (B)(4) IN THE RIGHT PULMONARY ARTERY) WERE SUCCESSFULLY PLACED ON (B)(6) 2018 AND THE TPA INFUSION RATE PER DEVICE WAS 1 MG/HR. THE TOTAL DOSE OF TPA ADMINISTERED WAS 2 MG PER HOUR. INFUSION OF TPA STARTED AT 15:30. AT 16:25 ON (B)(6) 2018, CARDIOPULMONARY RESUSCITATION WAS REQUIRED FOR HEMODYNAMIC COLLAPSE. MEDICATION WAS GIVEN FOR CARDIOPULMONARY RESUSCITATION AND INTUBATION BUT THE PATIENT EXPIRED. THE END OF THE INTERVENTIONAL PROCEDURE WAS DOCUMENTED TO BE 17:36 (TIME OF DEATH). THE INVESTIGATOR ASSESSED THE RELATIONSHIP TO THE PROCEDURE AS UNKNOWN, THE RELATIONSHIP TO THE EKOS DEVICE AS UNKNOWN, THE RELATIONSHIP TO THE THROMBOLYTIC DRUG AS UNKNOWN AND THE RELATIONSHIP TO ANTICOAGULANT DRUG AS UNKNOWN. DUE TO THE UNKNOWN RELATEDNESS TO THE STUDY DEVICE, THE RELATIONSHIP WILL BE CONSIDERED POSSIBLY RELATED FOR REPORTING PURPOSES. THE REPORTER WAS NOT THE TREATING PHYSICIAN. A REVIEW OF THE COMPLAINT DATABASE CONFIRMED THAT THIS PATIENT DEATH WAS NOT REPORTED TO EKOS BY THE TREATING PHYSICIAN AT THE TIME OF THE EVENT IN 2014. REFER TO MDR 3001627457-2018-00025 FOR EKOS CATHETER SERIAL # (B)(4) PLACED IN THE RIGHT PULMONARY ARTERY.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT #1 SUBMITTED TO REPORT THE UPDATED ASSESSMENT RECEIVED FROM THE PRINCIPLE INVESTIGATOR. THE CAUSE OF DEATH FOR SUBJECT (B)(6) WAS A MASSIVE PULMONARY EMBOLISM. THIS DEATH WAS NOT RELATED TO THE EKOS DEVICE. REFER TO INITIAL MDR FOR EVENT DESCRIPTION. REFER TO MDR 3001627457-2018-00025 FOLLOW UP #1 FOR EKOS CATHETER SERIAL (B)(4) PLACED IN THE RIGHT PULMONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635720 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION 500-55112 00858593006134

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death