BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIEVER24

    MDR report key: 14721950 · Received June 16, 2022

    Report

    Report Number
    3011525976-2022-00008
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    June 3, 2022
    Report Date
    June 16, 2022
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K213402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 PROVIDED, AND THE LOT HISTORY RECORDS 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 VASCULAR INJURY WAS THE RESULT OF PERFORATION, POTENTIALLY EXACERBATED BY ABNORMAL PATIENT ANATOMY; IN ADDITION, THE TREATING PHYSICIAN THOUGHT THE PATIENT'S CARCINOMA HISTORY MAY HAVE MADE THE VENTRICLE MORE SUSCEPTIBLE TO PERFORATION. CARDIAC PERFORATION, VALVULAR DISRUPTION/INJURY, PERICARDIAL EFFUSION, PAIN, 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 68-YEAR-OLD MALE PATIENT WITH A PULMONARY EMBOLISM UNDERWENT ATTEMPTED EMBOLECTOMY WITH THE INARI FLOWTRIEVER ON (B)(6) 2022. FOUR WEEKS PRIOR TO THE PROCEDURE, A CT ANGIOGRAM REVEALED A MASS ADHERING TO THE WALL IN THE MAIN RIGHT PULMONARY ARTERY (RPA) TOWARDS THE TRICUSPID ARTESIA (TA) AND UPPER LOBE. DURING THE PROCEDURE, 3 BIOPSY TISSUE SAMPLES WERE TAKEN TO DETERMINE THE NATURE OF THE MASS SINCE THE PATIENT HAD AN EXTENSIVE HISTORY OF RENAL CANCER. THE PATIENT WAS PLACED UNDER LOCAL ANESTHESIA WITH SEDATION AND GOOD, STABLE GUIDEWIRE POSITION WAS ACHIEVED IN THE TA. DUE TO INTRAJUGULAR ACCESS, THE CURVE IN THE WIRE WAS A BIT STEEP TOWARDS THE PULMONARY ARTERIES. THE PATIENT'S RIGHT VENTRICLE WAS NOT UNDER STRAIN AND THEREFORE SMALL, WHICH MADE THE CURVE EVEN STEEPER. PROPER DILATION OF THE ACCESS SITE WAS PERFORMED, AND THE GORE DRY SHEATH (GDS) WAS PLACED SUCCESSFULLY. THE TRIEVER24 (T24) WAS THEN INTRODUCED AND ADVANCED. THERE WAS DIFFICULTY ADVANCING THE T24 AT THE STEEP CURVE AND A DECISION WAS MADE TO EXCHANGE THE T24 WITH THE TRIEVER16. WHEN THE TRIEVER16 WAS BEING HANDED TO THE PHYSICIAN (PRIOR TO USE), THE PATIENT COMPLAINED OF PAIN IN THE STOMACH AREA AND COLLAPSED. A PERICARDIAL DRAINAGE WAS PREPARED AND PERFORMED IN 3 DIFFERENT DRAINS; 2 LITERS OF BLOOD WERE ASPIRATED AND RETURNED TO THE PATIENT VIA A SIDEPORT. URGENT OPEN-HEART SURGERY WAS PERFORMED, AND THE PERFORATION WAS SUTURED. DUE TO THE RAPID RESPONSE AND ABSENCE OF CARDIAC ARREST, THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY WITHOUT ANY BRAIN DAMAGE. THE SURGEON ELECTED NOT TO PROCEED WITH THE EMBOLECTOMY PROCEDURE AND THE ACCESS SITE WAS CLOSED. AT LAST REPORT, THE PATIENT WAS IN STABLE CONDITION AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090956 TRIEVER24 THROMBECTOMY SYSTEM QEW INARI MEDICAL, INC. 22-101 21120027 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| L| R AMPLATZ SUPERSTIFF 1 CM| FLOWSAVER| GORE DRYSEAL SHEATH 26 FR