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

Model Number	41-102
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
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.The case was reviewed by inari's chief medical officer, who concluded that the patient's death was the result of massive pe and delay in therapy.However, the difficulty involved in removing the clottriever xl catheter indicates a potential device malfunction.This potential malfunction could potentially cause or contribute to a death or serious injury if it were to recur.The device labeling includes the following warning statements: "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." "examine the clottriever xl catheter prior to insertion to verify it is not damaged." "ensure that clottriever xl catheter is withdrawn into the clottriever thrombectomy system sheaths prior to removal from patient to avoid vascular damage." the device labeling includes the following contraindication: "not indicated for the removal of fibrous, firmly adherent, or calcified material (e.G., atherosclero tic plaque)." manufacturer reference#: (b)(4).
Event or Problem Description
A 46-year-old female arrived to the hospital with a massive pulmonary embolism and was given 100 mg of tpa.Imaging performed when the patient arrived revealed clot in the right main pulmonary artery, inferior vena cava (ivc), clot above the renal veins, and renal vein clot.A thrombectomy was performed with inari devices 2 days after the patient's initial arrival.Imaging confirmed clot remained in the right main pulmonary artery, but it was unclear if there was ivc clot.Imaging also revealed right heart strain, but both legs were free from deep vein thrombosis (dvt).The physician decided to treat the suspected ivc clot prior to the pe.Fentanyl was given and a venogram was performed which confirmed ivc clot.The clottriever xl catheter (ctxl) was chosen to address the ivc clot due to the size of the thrombus.The ctxl's 1st pull removed a small amount of chronic thrombus.The 2nd and 3rd attempts did not yield clot.Another venogram was performed which revealed large thrombus remained in the ivc, suprarenal, and renal veins.The 4th pull removed a large chronic clot.This occluded the clottriever 16 fr sheath, and the sheath had to be removed to pull the ctxl out of the groin.Removal of the ctxl was not easy but eventually achieved without patient injury.At this point, the patient decompensated, and a code was called.The physician quickly crossed the heart and placed a guidewire into the right interlobar pulmonary artery.The flowtriever system was used to perform a pulmonary embolism (pe) thrombectomy.3 aspirations were performed which yielded clot from the first 2 aspirations.During the aspirations, the patient was intubated, and wire position was lost.Pulseless electrical activity was determined, and chest compressions were started.3 defibrillations were also performed with the administration of multiple resuscitation drugs.The patient never recovered.

• 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: 20905184
• Report Number: 3020347218-2024-00050
• Device Sequence Number: 4070709
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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 Model Number: 41-102
• 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: 11/11/2024
• Initial Report FDA Received Date: 12/11/2024
• 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 SHEATH 16 FR.
• Patient Age: 46 YR
• Patient Sex: Female