MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER 24; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	22-101
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A 20-year-old female patient with pulmonary embolism (pe) and concomitant deep vein thrombosis (dvt), being treated with anticoagulation, underwent pe thrombectomy with inari devices on (b)(6) 2024.The pe clot age was estimated at 28 days.During thrombectomy, the medical team noticed the flowtriever 2 catheter (ft2) caught on the marker band of the treiver24 (t24,) then while pulling the t24 back, the marker band separated from the t24 catheter and remained in the patient's inferior vena cava (ivc), still on the guidewire.The marker band was aspirated and retrieved with a newly opened t24 device.The removal of the marker band prolonged the surgery by an additional ten minutes.The case was concluded.There was no resulting patient injury.Postoperatively, the patient is in stable condition.
Additional Manufacturer Narrative
The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.The triever24 has been returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted.Manufacturer reference #: (b)(4).
Additional Manufacturer Narrative
The triever24 (t24) was returned to the manufacturer and evaluated.Visual inspection of the device confirmed the marker band was no longer attached to the catheter and adhesive residue was observed in the marker band's absence.The device also had three large kinks in the catheter.The flowtriever 2 catheter (ft2) likely compromised the structure of the t24 tip, possibly due to not being fully collapsed when attempting to pull the device through the t24, when the ft2 caught on the t24.Excessive force may have been used to pull the ft2 though the t24, when the ft2 became caught on the t24.The marker band likely dislodged due to subsequent use of the t24 following the marker band being compromised after the ft2 distal end got caught on the t24 during use.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.There have been no similar complaint events for this lot number.The device labeling includes the following warning statement: "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract and collapse the flowtriever disk(s) into the triever 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: TRIEVER 24
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92816
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92816
• Manufacturer Contact: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92816 ; 6513233614
• MDR Report Key: 19647191
• Report Number: 3020347218-2024-00029
• Device Sequence Number: 12401430
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 03/06/2026
• Device Model Number: 22-101
• Device Lot Number: 24030018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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: AMPLATZ SUPER STIFF GUIDEWIRE.; FLOWTRIEVER 2 CATHETER, M.
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 72 KG