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); Use of Device Problem (1670)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	05/16/2024
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 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 potentially the result of inadvertent clot embolism.Manufacturer reference #: (b)(4).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.".
Event or Problem Description
The patient was a 44-year-old female with deep vein thrombosis and clot within the inferior vena cava (ivc).Additionally, the patient had stage 4 brain cancer and had been undergoing chemotherapy with the addition of a prior operation related to the cancer.A thrombectomy was performed with a non-inari device to address the patient's clot, but little clot was extracted and most of the iliac clot was pushed forward into the ivc where there was a pre-existing filter in place.The procedure was aborted after significant blood loss and hemodynamic decompensation occurred.A second thrombectomy was then scheduled with a plan to use the inari protrieve sheath from the internal jugular and aspirating using the triever20 (t20) and triever16 curve (t16c).The procedure was conducted 6 days after the initial intervention due to the patient's poor hemodynamics and vitals.Access and wire positioning were obtained but a pre-procedural angiogram was not performed.The t20 was advanced over the wire and placed within the filter.Four aspirations were performed which resulted in minimal clot extracted.An angiogram was performed at this time which confirmed the position of the clot burden.A t16c was then used but aspirations yielded no clot.Several additional aspirations were performed with the t16c and t20 which removed nominal clot.The procedure plans were then changed to remove the filter and to use a clottriever xl catheter (ctxl) through the protrieve sheath.The filter was removed and the ctxl was inserted.The first pass went smoothly, and the catheter was cleaned and re-inserted.A second pass was performed when the patient began to complain of stomach pain.The physician continued to pull the ctxl into the protrieve, but the coring element was not collapsed.The physician addressed this by advancing the ctxl forward to collapse the coring element.The device unfortunately became stuck in the sheath, but the physician was able to remove it quickly.After the ctxl was removed, the patient crashed.A code was called, and cpr was conducted.Unfortunately, the patient expired after 15 minutes of resuscitation efforts.

• 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: 19531317
• Report Number: 3020347218-2024-00027
• Device Sequence Number: 7574926
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K223210
• 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): 06/12/2024

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: 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: 05/16/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: PROTRIEVE SHEATH; TRIEVER16 CURVE; TRIEVER20
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 44 YR
• Patient Sex: Female