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

Model Number	42-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Loss of consciousness (2418)
Date of Event	02/21/2023
Type of Reportable Event	Death
Event or Problem Description
A female patient in her 50s with a history of congestive heart failure (chf) and hypertension presented with left leg swelling and pain.The patient was diagnosed with deep vein thrombosis (dvt) in the left common femoral, left common iliac, left external iliac, and left femoral veins; the clot age was estimated at 4 days.On (b)(6) 2023, the patient underwent a thrombectomy with the inari clottriever system.Once the clot was confirmed using intravascular ultrasound (ivus) and an 8 fr cordis sheath, a clottriever sheath was placed and clottriever bold catheter was advanced after wire positioning was obtained.Heparin was administered during the case (7,000 units total) and 4 catheter passes were performed which removed 100% of the clot as confirmed via angiogram.The clot removed was described as very acute.The clottriever bold catheter was removed from the patient.The physician then introduced ivus to confirm clot removal and to measure for stenting when the patient became unresponsive.The patient was repositioned from prone to supine and tegaderm dressing was placed over the popliteal access site and cpr was initiated.A bolus of tpa was administered once the patient became responsive.Unfortunately, the patient arrested numerous times, was unable to be resuscitated, and eventually expired.
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided; however, the company recorded all lots shipped to the facility and each of the possible 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 death was possibly the result of distal embolization.Distal embolization of blood clots and cardiovascular collapse are listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).

• Brand Name: CLOTTRIEVER BOLD 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: 16594903
• Report Number: 3020347218-2023-00004
• Device Sequence Number: 5088971
• Product Code: QEW
• UDI-Device Identifier: 00850291007314
• UDI-Public: 00850291007314
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K221531
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 42-102
• 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: 02/21/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; CORDIS SHEATH 8 FR; IVUS
• Outcome Attributed to Adverse Event: Life Threatening; Death; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female