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

Model Number	42-102
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	12/02/2024
Type of Reportable Event	Death
Event or Problem Description
The patient was a 51-year-old female with lower left extremity deep vein thrombosis (dvt).An ultrasound showed acute dvt.No chest computed tomography scan was performed to check for pre-existing pulmonary embolism (pe).Access and wire positioning were obtained without issue.Venograms revealed occlusive dvt in the left popliteal with no outflow to the inferior vena cava (ivc).The right popliteal was open except for a small amount of thrombus at the proximal common iliac.The clottriever sheath, 16 fr was placed in the right popliteal and the clottriever sheath, 13 fr was placed in the left popliteal.The plan was to use the clottriever xl catheter (ctxl) to clear the ivc and for the clottriever bold catheter (ct bold) to clear the iliac on the right.Ct bold would then be used to clean the left at the lower left extremity.The 1st pass with the ctxl resulted in a collapsed coring element at the right common iliac.The patient noticed significant pain and the physician felt resistance.The coring element was slightly sheathed into the catheter and the unit was moved until resistance was met again.The coring element was pulled further into the outer catheter which allowed the unit to be removed.A 2nd pass was performed which led to a similar collapse at the right common iliac.Fortunately, the device was removed without issue.Upon the 3rd pass, another collapse occurred at the right common iliac.The patient became very anxious and decompensated.The ctxl was removed and a venogram was performed to check for vein avulsion.The venogram showed nothing of concern and a pe was suspected.The patient was flipped onto her back and lost her pulse shortly after.The patient coded for 48 minutes before passing away.Post-procedural discussion revealed that the patient had a history of multiple pes.Additionally, the patient was morbidly obese with multiple comorbidities.A transesophageal echocardiogram performed during the code revealed a massive right ventricle and massively dilated pulmonary arteries.
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided, the lot history records of all potential lots shipped to the facility 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 the result of inadvertent clot embolism.Distal embolization of blood clots is identified in the device labeling as possible adverse events/complications.The device instructions for use include the following warning statement: "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the collection bag and coring element into the outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel." 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: 21020928
• Report Number: 3020347218-2024-00057
• Device Sequence Number: 4223347
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K242557
• 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): 12/26/2024

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?: 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: 12/02/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 BOLD CATHETER; CLOTTRIEVER SHEATH, 13 FR; CLOTTRIEVER SHEATH, 16 FR
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Death
• Patient Age: 51 YR
• Patient Sex: Unknown