MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER24; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	22-101
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/17/2024
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 returned to the manufacturer for evaluation and the findings and conclusions will be provided in a follow-up report.The device labeling includes a statement recommending use of the 24 fr introducer sheath with the triever24 catheter.Manufacturer reference #: (b)(4).
Event or Problem Description
An 80-year-old male patient with a preexisting pulmonary embolism (pe) in the right pulmonary artery (rpa) underwent a thrombectomy with the inari flowtriever system on (b)(6), 2024.The clot age was estimated at 14 days.The hospital did not have an introducer sheath available, so the triever24 (t24) was inserted without the recommended 24 fr introducer sheath.During insertion the dilator retracted slightly resulting in some buckling of the catheter.Additional kinking of the catheter was observed when advancing to the rpa, however, it did not prevent the device from aspirating.The physician was unable to remove any clot and elected to abort the case when the patient reported experiencing discomfort.Upon removal of the t24 the distal section of the t24 catheter separated from the main catheter body.The distal section remained in the right femoral artery, but the physician was able to remove it without surgical intervention.Once removed from the patient, it was apparent that the internal braiding had become uncoiled.Both portions of the device were removed from the vessel without incident and there was no resulting patient injury or vessel damage.The patient was reported to be stable postoperatively.
Additional Manufacturer Narrative
The triever24 (t24) was returned to the manufacturer and evaluated.Visual inspection of the device revealed the t24 catheter was broken into two halves and 26 cm of the distal end of the catheter was completely separated from the inner coil.Testimonial provided by company representative present during the surgical case revealed the catheter shaft kinked prior to fully advancing the device into the patient and the t24 was advanced 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.In addition, excessive force was applied that caused kinking which induced weak areas in the catheter.When the catheter was subsequently advanced through the vasculature the weak areas were susceptible and ultimately caused the catheter to break.The device labeling recommends the use of a 24 fr introducer sheath and 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).

• Brand Name: TRIEVER24
• 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: 18728107
• Report Number: 3020347218-2024-00009
• Device Sequence Number: 6310795
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,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: 06/20/2025
• Device Model Number: 22-101
• Device Lot Number: 23060085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• 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 SUPER STIFF GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male