MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER16; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	25-101
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
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 was discarded by the user facility and is not available for evaluation.There have been no similar complaint events for this lot number.The case was reviewed by inari's chief medical officer, who concluded that the device breakage and subsequent need for intervention was likely the result of user error where the catheter was subjected to excessive force.The device labeling includes the following warning statement: avoid using excessive force to advance or retract against resistance.If excessive resistance occurs, retract and collapse the distal disks into the catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation.Manufacturer reference #: (b)(4).
Event or Problem Description
A 78-year-old male patient with bilateral lower extremity deep vein thrombosis (dvt) with some clot present in the inferior vena cava (ivc) underwent a thrombectomy using the inari flowtriever system on (b)(6) 2024.The clot age was estimated at 5 days.After access was obtained and a clottriever 16 fr sheath was placed, the triever16 (t16) was advanced through the ct sheath into the inferior vena cava.The physician reported feeling resistance superior to the renal veins.An aspiration was performed but no clot was removed.The physician then attempted to reposition the t16 back towards the sheath but encountered resistance a second time.The physician continued applying pulling force to the point of device separation/breakage and the t16 unraveled inside the vessel.There was no resulting vessel perforation.Intervention was performed to retrieve the device fragment from the patient (using a 10 mm fogarty balloon over the guidewire).The fragments were completely removed from the original incision site and the clottriever 16 fr sheath was removed without incident.A clottriever 13fr sheath was then inserted and the thrombectomy was completed successfully using the clottriever system.The thrombectomy removed 90% of the dvt.

• Brand Name: TRIEVER16
• 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: 18718196
• Report Number: 3020347218-2024-00007
• Device Sequence Number: 15586360
• Product Code: QEW
• UDI-Device Identifier: 00850291007130
• UDI-Public: 00850291007130
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K211013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2024

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: 07/25/2025
• Device Model Number: 25-101
• Device Lot Number: 23070014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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: CLOTTRIEVER SHEATH 16 FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 104 KG