MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER20; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	21-101
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.The device is being returned and the results of the investigation will be provided in a follow-up report.Vessel dissection is listed in the device labeling as a potential complication / adverse event.Manufacturer reference #: (b)(4).
Event or Problem Description
A female patient with left lower extremity deep vein thrombosis (dvt) underwent a thrombectomy on (b)(6), 2024 using the inari triever20 (t20).The clot age was estimated at 14 days.Three access points were made in the right intrajugular, left popliteal, and right popliteal.Wire positioning was obtained without issue and the triever20 was advanced without an introducer sheath.Several aspirations were performed which cleared the entire clot from the left popliteal vein.As the t20 catheter was being removed, a portion detached and the physician halted the procedure to perform imaging.A vascular surgeon intervened to perform a venous cut-down to remove the remaining portion of the catheter.All device fragments were removed successfully; the cut-down and popliteal veins were closed and a final venogram was performed.On (b)(6), 2024 follow-up was requested from the treating physician who reported the patient was "doing great" postoperatively.
Event or Problem Description
Patient follow-up was requested on (b)(6) 2024, but no new information was provided.
Additional Manufacturer Narrative
The triever20 (t20) catheter along with ancillary products (hemostats and amplatz ss 0.035" guidewire) were returned to the manufacturer and evaluated.Visual inspection of the t20 catheter revealed it was split into three separate pieces.The inner coil was separating from the catheter outer jacket pieces.According to the report provided by the company representative who attended the surgical case, the t20 catheter was advanced into the vein without using an introducer sheath.The device evaluation concluded the event was attributed to unintended use error where the catheter was advanced without using an introducer sheath.This technique exposes the catheter to higher than tested/normal forces.The catheter separated due to excessive force used to pull on the catheter while inside the vasculature.The excessive force likely kinked the catheter shaft, creating a weak point in the catheter, and consequently causing the outer jacket to split and the catheter to separate.The device labeling recommends the use of a 22 fr introducer sheath and includes the following warning statement: " avoid using excessive force to advance or retract the flowtriever catheter or triever20 against resistance.If excessive resistance occurs, retract and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation".Manufacturer reference #: (b)(4).

• Brand Name: TRIEVER20
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer Contact: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 18628534
• Report Number: 3020347218-2024-00005
• Device Sequence Number: 15436448
• Product Code: QEW
• UDI-Device Identifier: 00850291007079
• UDI-Public: 00850291007079
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 21-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ SUPERSTIFF GUIDEWIRE 0.035"; FLOWSAVER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female