BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIEVER20 CURVE

    MDR report key: 20207802 · Received September 12, 2024

    Report

    Report Number
    3020347218-2024-00041
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 14, 2024
    Report Date
    September 12, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007215
    PMA / PMN Number
    K231848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INARI DEVICES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. THE DEVICE IDENTIFIERS WERE NOT PROVIDED, THE LOT HISTORY RECORDS OF ALL POTENTIAL LOTS SHIPPED TO THE FACILITY WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. THE CASE WAS REVIEWED BY INARI'S CHIEF MEDICAL OFFICER, WHO CONCLUDED THAT THE PATIENT'S INJURY AND DETERIORATION WAS THE RESULT OF CATHETER PERFORATION. MANUFACTURER REFERENCE #: (B)(4). CARDIOVASCULAR COLLAPSE, PERICARDIAL EFFUSION, AND VESSEL DISSECTION/PERFORATION ARE IDENTIFIED IN THE DEVICE LABELING AS POSSIBLE ADVERSE EVENTS/COMPLICATIONS.

    Description of Event or Problem · 0

    AN 81-YEAR-OLD FEMALE UNDERWENT A THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM TO ADDRESS HER PULMONARY EMBOLISM. A STIFF ANGLED GLIDEWIRE WAS USED IN CONJUNCTION WITH A VERT CATHETER TO WIRE THE TRUNCUS ANTERIOR. THE WIRE APPEARED TO ADVANCE IN THE APPROPRIATE DIRECTION WITHIN THE VESSEL. THE GLIDEWIRE WAS EXCHANGED FOR AN AMPLATZ SUPERSTIFF GUIDEWIRE. THE TRIEVER20 CURVE WAS INTRODUCED COAXIAL WITH THE TRIEVER24 TO THE RIGHT PULMONARY ARTERY (RPA) AND AN ASPIRATION WAS PERFORMED. THE PHYSICIAN PERFORMED A SELECTIVE ANGIOGRAM OF THE RPA WHEN IT WAS NOTICED THAT THE IMAGE LOOKED ODD. THE CATHETERS WERE PULLED BACK, AND ANOTHER ANGIOGRAM WAS PERFORMED WHICH REVEALED EXTRAVASATION OF CONTRAST AND A LARGE PERICARDIAL EFFUSION. THE PROCEDURE WAS HALTED, AND THE PATIENT DECOMPENSATED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH CONFIRMED THE PERICARDIAL EFFUSION. A PERICARDIAL DRAIN WAS INSERTED BUT THE PATIENT CONTINUED TO DECOMPENSATE. THE PATIENT WAS INTUBATED, AND A TRANSESOPHAGEAL ECHOCARDIOGRAM PROBE WAS PLACED. MULTIPLE ATTEMPTS WERE MADE TO ALLOW THE BLEEDING TO STOP ON ITS OWN. AT ONE POINT THE SURGICAL TEAM PREPPED THE PATIENT AND THE PATIENT'S CHEST WAS OPENED FOR REPAIR. THE PATIENT SURVIVED THE SURGERY DURING WHICH A LACERATION IN THE ANTERIOR RIGHT VENTRICLE OUTFLOW TRACT WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622950 TRIEVER20 CURVE PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 21-201 00850291007215

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Hospitalization| L| R AMPLATZ SUPERSTIFF GUIDEWIRE| FLOWSAVER| INTRI24 SHEATH| STIFF ANGLED GLIDEWIRE| TRIEVER24| VERT CATHETER