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

Model Number	46-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 injury was the result of inadvertent vessel dissection.Manufacturer reference #: (b)(4).
Event or Problem Description
A 65-year-old female presented with left lower extremity pain and swelling for the past 4 days.The patient was noted to have a history of deep vein thrombosis (dvt) 20 years prior.A duplex ultrasound was performed which revealed left iliofemoral dvt.Pre-case planning decided to use the clottriever bold (ct bold) and clottriever xl (ctxl).Venacore was also planned to be used to address any areas of residual chronic thrombus.Bilateral popliteal access was obtained and venograms were performed which revealed lower left extremity thrombus with extension into the inferior vena cava.A clottriever 16 fr sheath was placed, and the catheters were advanced.8 passes were performed with the ct bold and 2 with the ctxl.A repeat venogram was performed which revealed a focal area below the common femoral vein.The physician felt it was chronic thrombus and deployed the venacore.2 passes were performed with the venacore but no thrombus was removed.There were signs of an occlusion in the sheath.The physician pulled the material out and expressed that it looked like a vein.The sheath was re-inserted, and a repeat venogram was performed.This revealed extravasation proximal to the sheath with flow not extending past the treated area.Prolonged ballooning was performed which resolved the extravasation.Stents were deployed and a final venogram revealed restored flow.The access site was closed, and the procedure was concluded.

• Brand Name: VENACORE
• 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: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 9494132147
• MDR Report Key: 21270261
• Report Number: 3020347218-2025-00006
• Device Sequence Number: 3916101
• Product Code: QEW
• UDI-Device Identifier: 00850291007406
• UDI-Public: (01)00850291007406(17)260808(10)24080050
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K234034
• 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): 01/02/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2026
• Device Model Number: 46-101
• Device Lot Number: 24080050
• 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: 01/02/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2024
• 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 BOLD CATHETER.; CLOTTRIEVER SHEATH, 16 FR.; CLOTTRIEVER XL CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female