BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO SYSTEM

    MDR report key: 15221951 · Received August 12, 2022

    Report

    Report Number
    3005168196-2022-00369
    Event Type
    Death
    Date Received
    August 12, 2022
    Date of Event
    March 1, 2018
    Report Date
    August 12, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K192833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510(K)# THAT ALSO APPLY TO THIS COMPLAINT: K161523. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. EMBOLI AND MYOCARDIAL INFARCTION ARE INCLUDED AS POSSIBLE COMPLICATIONS IN THE INSTRUCTIONS FOR USE (IFU) FOR THE INDIGO ASPIRATION SYSTEM. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2022-00370, 3005168196-2022-00371.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 18-JUL-2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "CONTINUOUS ASPIRATION MECHANICAL THROMBECTOMY FOR THE MANAGEMENT OF INTERMEDIATE- AND HIGH-RISK PULMONARY EMBOLISM: DATA FROM THE FIRST COHORT IN PORTUGAL" (CALE ET AL. 2022). IN THIS SINGLE CENTER RETROSPECTIVE STUDY, TWENTY-NINE PATIENTS UNDERWENT THROMBECTOMY PROCEDURES TO TREAT PULMONARY EMBOLISM (PE) USING THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND THE INDIGO SYSTEM SEPARATOR 8 (SEP8) BETWEEN MARCH 2018 AND MARCH 2020. IN ONE PATIENT WITH MARKED ANGULATION OF THE MAIN PULMONARY ARTERY BIFURCATION, THE CAT8 KINKED. THEREFORE, THE CAT8 WAS NOT CORRECTLY POSITIONED WITHIN THE THROMBUS THE RIGHT PULMONARY ARTERY. ONE PATIENT EXPIRED DURING THE PROCEDURE DUE TO MULTIORGAN FAILURE IN THE EVOLUTION OF CARDIOGENIC SHOCK OVER SEVERAL HOURS. HOWEVER, THE RELATIONSHIP BETWEEN THE REPORTED EVENTS AND USE OF THE INDIGO SYSTEM WAS NOT SPECIFIED. ANOTHER PATIENT DIED AT THE END OF THE PROCEDURE AND PE RECURRENCE WAS CONSIDERED THE PROBABLE CAUSE OF DEATH; HOWEVER, THE RELATIONSHIP BETWEEN THE REPORTED EVENTS AND USE OF THE INDIGO SYSTEM WAS NOT SPECIFIED. ANOTHER PATIENT SUFFERED A PULMONARY MACROEMBOLIZATION DURING THE INDIGO SYSTEM DEVICE PROGRESSION, FOLLOWED BY CARDIORESPIRATORY ARREST WITH NEED FOR CARDIOPULMONARY RESUSCITATION, MECHANICAL VENTILATION AND SYSTEMIC THROMBOLYSIS. IT WAS REPORTED THAT THIS PATIENT SURVIVED THE PROCEDURE BUT EXPIRED ON DAY TWELVE OF HOSPITALIZATION WITH ACTIVE URINARY CANCER. THREE PATIENTS WERE ANEMIC AFTER USE OF THE INDIGO SYSTEM AND REQUIRED A BLOOD TRANSFUSION WITHIN FORTY-EIGHT HOURS WITHOUT VISIBLE BLEEDING. IT WAS NOTED THAT THESE EVENTS DID NOT RESULT IN HEMODYNAMIC COMPROMISE. HOWEVER, THE RELATIONSHIP BETWEEN THE REPORTED EVENTS AND USE OF THE INDIGO SYSTEM WAS NOT SPECIFIED. TWO PATIENTS HAD MILD HEMOPTYSIS DURING THE PROCEDURE WITH NO NEED OF PERCUTANEOUS OR SURGICAL INTERVENTION OR MECHANICAL VENTILATION. HOWEVER, THE RELATIONSHIP BETWEEN THE REPORTED EVENTS AND USE OF THE INDIGO SYSTEM WAS NOT SPECIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE, NOR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL MALFUNCTIONS AND/OR ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2906127 INDIGO SYSTEM QEW QEW PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death