BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIEVER20 CATHETER

    MDR report key: 19169748 · Received April 23, 2024

    Report

    Report Number
    3020347218-2024-00020
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 23, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007079
    PMA / PMN Number
    K213402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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, HOWEVER, THE LOT HISTORY RECORDS OF ALL POTENTIAL LOTS SHIPPED TO THE FACILITY WERE REVIEWED AND 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 STROKE WAS THE RESULT OF THE THROMBECTOMY PROCEDURE. THE PATIENT ALSO HAD A PATENT FORAMEN OVALE, WHICH IS A POSSIBLE CONTRIBUTING FACTOR. DISTAL EMBOLISM, STROKE, AND CLINICAL DETERIORATION, ARE LISTED IN THE DEVICE LABELING AS POTENTIAL COMPLICATIONS / ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A 71-YEAR-OLD FEMALE PATIENT WITH ESOPHAGEAL CANCER WAS DIAGNOSED WITH BILATERAL PULMONARY EMBOLISM (PE) VIA COMPUTED TOMOGRAPHY ANGIOGRAPHY. THE PATIENT WAS SCHEDULED FOR THROMBECTOMY USING INARI DEVICES. THE CLOT AGE WAS ESTIMATED AT 7 DAYS. WIRE POSITIONING WAS OBTAINED WITHOUT ISSUE AND A TRIEVER20 (T20) CATHETER WAS ADVANCED INTO PLACE. AN ASPIRATION WAS PERFORMED IN THE RIGHT PULMONARY ARTERY WHICH DID NOT YIELD CLOT. THE T20 WAS ADVANCED AGAIN, AND A SECOND ASPIRATION WAS PERFORMED; HOWEVER, THE CLOT BECAME LODGED IN THE TIP OF THE T20. THE PHYSICIAN PROCEEDED TO REMOVE THE T20 CATHETER FROM THE PATIENT THROUGH THE INARI INTRI24 SHEATH. UPON INITIAL EXAMINATION, THERE WAS NO CLOT PRESENT IN THE LARGE BORE SYRINGE OR CATHETER. THE INTRI24 SHEATH WAS REMOVED UNDER PRESSURE AND FLUSHED, WHICH YIELDED A LARGE PORTION OF CLOT. THERE WAS ALSO A LARGE CLOT PRESENT AT THE ACCESS SITE WHICH WAS REMOVED MANUALLY. THE INTRI24 SHEATH AND T20 CATHETER WERE CLEANED AND ADVANCED BACK INTO PLACE WHEN THE PATIENT REPORTED EXPERIENCING DIPLOPIA IN THE LEFT EYE AND VERTIGO AND SHOWED SIGNS OF RESTLESSNESS. A RAPID RESPONSE WAS INITIATED; THE PATIENT RESPONDED TO VERBAL COMMANDS, BUT WAS UNABLE TO VERBALIZE OR OPEN HER EYES. IT WAS DETERMINED THAT THE PATIENT WAS EXPERIENCING A STROKE. IT IS ASSUMED THAT THE PROCEDURE WAS CONCLUDED, AND THE PATIENT WAS SENT FOR STROKE TREATMENT AND ADMITTED TO THE INTENSIVE CARE UNIT. PATIENT FOLLOW-UP REVEALED THAT THE PATIENT HAD AN UNDIAGNOSED PATENT FORAMEN OVALE (PFO). THE PATIENT WAS OBSERVED WITH A LEFT MIDDLE CEREBRAL ARTERY OCCLUSION AS WELL AS THROMBUS WITHIN THE RIGHT COMMON CAROTID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382867 TRIEVER20 CATHETER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 21-101 00850291007079

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Life Threatening| H| S| R 125 CM VERT CATHETER| ANGLED PIGTAIL CATHETER| BENSON WIRE| INTRI24 SHEATH