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

Model Number	44-101
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A 71-year-old female with thrombus in an iliac stent underwent a thrombectomy with inari devices to treat her deep vein thrombosis (dvt).The patient had 5 stents in place over 14 years.Revcore was used a year prior when she presented to the emergency department.The plan was to use a clottriever sheath 16fr to access left femoral vein, but the sheath would not advance into the access site.The sheath was pulled back and off the wire.However, the white internal dilator had caught on the sheath and was not smooth, so a cook sheath 16fr.Was used instead.Imaging was performed prior to the revcore being advanced over the guidewire and positioned near the thrombus in the stent.The revcore element was opened slowly, and imaging was performed while rotating the coring element.No resistance was felt so the physician increased the element size slowly under imaging.At this point, some resistance was felt so the physician pulled the revcore distal while rotating clockwise then counterclockwise.Rotations were stopped and imaging was performed.The revcore was re-sheathed and removed.Resistance was met upon removal from the stent.Imaging revealed that the revcore was engaged with the stent.The revcore was unsheathed and pushed it back into the stent lumen, to try and disengage from stent.The revcore was pulled out of the patient with a portion of the stent.Imaging was performed and a new stent placed.The patient was reported to be doing well after the procedure.
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 stent complication was the result of user error.The device labeling includes the following warning statements: "when the revcore is in the path of an exposed stent with broken/fractured struts, a stent <10mm in diameter, or a stent compressed to <10mm, damage to the stent, the coring element, or dislodgement of the stent, etc.May occur." "proceed with caution when using revcore in or near a recently deployed stent.The revcore thrombectomy catheter has not been tested for post-dilation of stents." "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the coring element into the outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel." manufacturer reference #: (b)(4).

• Brand Name: REVCORE
• 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: 21370418
• Report Number: 3020347218-2025-00009
• Device Sequence Number: 8482366
• Product Code: QEW
• UDI-Device Identifier: 00850291007383
• UDI-Public: (01)00850291007383(17)250511(10)23050039
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223609
• 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): 02/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2025
• Device Model Number: 44-101
• Device Lot Number: 23050039
• 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: 01/14/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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 16FR; COOK SHEATH 16FR
• Patient Age: 71 YR
• Patient Sex: Female