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

Model Number	40-102
Medical Device Problem Codes	Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiac Arrest (1762); Tachycardia (2095)
Date of Event	09/23/2022
Type of Reportable Event	Death
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.The ct sheath did not cause or contribute to the reported event.The case was reviewed by inari's chief medical officer, who concluded that the patient's death was the result of distal embolism.Distal embolization of blood clots and cardiovascular collapse are listed in the device labeling as potential complications / adverse events.The labeling also includes the following warning statement: when used in patients with an ivc filter, damage to the filter, the collection bag, or dislodgement of the ivc filter, etc.May occur.Manufacturer reference #: (b)(4).
Event or Problem Description
A 53-year-old male patient presented with a clotted inferior vena cava (ivc) filter with the deep vein thrombosis (dvt) extending to the left popliteal vein.The patient experienced a previous adverse event from an arterial procedure and the right leg veins were ligated.On (b)(6) 2022, the patient underwent a thrombectomy using the inari clottriever (ct) thrombectomy system.Due to the right leg being ligated, the interventional cardiologist elected to place a long sheath from the internal jugular (ij) vein down to prevent the ct collection bag from interacting with the filter.The wire was successfully externalized from both access points, but the sheath was unable to be completely delivered beyond the filter.The procedure continued, and 2 successful passes were made with the ct catheter which produced significant clot yield.However, on the third pass, the ct collection bag caught on the filter and slowly pulled the filter towards the left common iliac vein (lciv).At this point approximately 70% of the clot had been evacuated and the physician removed the ivc filter from the ij.Although the ivc removal was accomplished without damaging the ct collection bag, the patient deteriorated and a pulmonary embolism was suspected.The patient's heart rate (hr) increased from 90 to 130 bpm.Shortly afterwards, the patient's heart rate stabilized, but the patient subsequently decompensated and became unresponsive.A code was initiated, but the team was unable to resuscitate the patient and he expired.

• Brand Name: CLOTTRIEVER 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: kit cariquitan ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 15655261
• Report Number: 3020347218-2022-00004
• Device Sequence Number: 19446786
• Product Code: QEW
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

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: 03/04/2024
• Device Model Number: 40-102
• Device Lot Number: 22030008
• 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: 09/23/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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, 13 FR
• Outcome Attributed to Adverse Event: Required Intervention; Death; Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 100 KG