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

Model Number	41-102
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with deep vein thrombosis (dvt) underwent a thrombectomy with inari devices.Imaging revealed a tumor thrombus that extended from the right atrium all the way to the inferior vena cava (ivc) and to the mid-femoral vein on the left leg.The clot age was estimated at 100 days.The intr24 sheath and triever24 were initially used to aspirate thrombus from the right atrium (ra).Several aspirations were performed before the physician realized that the thrombus was wall-adherent, and aspirations would not be effective.The decision was then made to use the clottriver xl catheter (ctxl).A pass was performed which removed tumor thrombus from the ra.The intri24 sheath was swapped with a protrieve sheath so the ctxl could be used in the ivc.The ctxl was deployed, and a pass was performed.A significant amount of tumor thrombus was removed using the collection bag.Upon attempting to remove the ctxl from the protrieve sheath, the device became overloaded with tumor/clot material and was unable to be removed through the sheath.After multiple attempts to remove the device using excessive force and over sheathing, the physician elected to perform a venous cut-down.A cut-down was performed, but the device was still unable to be removed.A balloon angioplasty was performed inside the device to attempt to deform the thrombus and remove the sheath, but this was unsuccessful as well.Ultimately, a larger incision placed above the confluence was made in order to remove the device.The tumor thrombus was successfully removed from the treatment area.
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.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 venous cutdown was the result of oversized tumor clot.The device labeling includes the following warning statement: not indicated for the removal of predominantly fibrous, firmly adherent, or calcified material (e.G., atherosclerotic plaque).Manufacturer reference #: (b)(4).

• Brand Name: CLOTTRIEVER XL CATHETER
• 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: 18253128
• Report Number: 3020347218-2023-00024
• Device Sequence Number: 7059930
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K223210
• 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): 12/01/2023

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: 10/04/2025
• Device Model Number: 41-102
• Device Lot Number: 23100009
• 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: 11/03/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2023
• 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: INTRI24 SHEATH; PROTRIEVE SHEATH; TRIEVER24
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown