MAUDE Adverse Event Report: INARI MEDICAL, INC. INARI CLOTTRIEVER SHEATH; EMBOLECTOMY CATHETER

Model Number	50-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Respiratory Arrest (4461)
Date of Event	12/23/2020
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; 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 suffered from an underappreciated pulmonary embolism and baseline right ventricle dysfunction.In addition to the preexisting pe and sedation, the clottriever may have contributed to possible distal embolization of the dvt clot, leading to a pe.Distal embolization of blood clots and cardiovascular collapse are listed in the device labeling as potential complications / adverse events.This mdr is for the inari clottriever sheath device.Refer to mdr #(b)(4) for the other inari device involved in this event.Manufacturer reference #: (b)(4).
Event or Problem Description
A (b)(6) year-old female patient presented to the emergency department with right lower extremity pain and swelling on (b)(6) 2020.The significant medical history (as disclosed to the company representative prior to the case) included: morbid obesity, prior left lower extremity deep vein thrombosis (dvt), and non-compliance with anticoagulation medication (xarelto).On (b)(6) 2020, the inari clottriever (ct) was used to attempt to treat the dvt.Heparin was administered intravenously, and the patient was placed in a prone position.Ultrasound was used to guide access with a micropuncture kit via the right popliteal vein (rpop) and a venogram revealed clot in the right common femoral vein (rcfv), extending distally.Intravascular ultrasound revealed no clot in the distal inferior vena cava or right common iliac vein, and clot was seen in the right external iliac vein (reiv), rcfv, right femoral vein, and rpop.With a guidewire anchored in the subclavian vein, the ct sheath was inserted and advanced to the proximal reiv.The ct catheter was advanced before being pulled back, yielding some clot.A second pullback yielded a large amount of chronic clot.The patient gagged or coughed, but it resolved once zofran was given.At the beginning of the third pass.The patient was unresponsive (heart rate 50 bpm and no blood pressure reading on the monitor).A code was initiated and cpr was given for over 40 minutes.During the resuscitation attempts, another physician made the company representative aware of a computed tomography angiogram (cta) that had not been disclosed during the preoperative case planning.The cta showed a preexisting bilateral pulmonary embolism (pe) and stated there was no right heart strain.However, upon examination of the images and videos, the rv/lv ratio appeared > 0.9, indicating the presence of right heart strain.The company representative shared this information with the performing physician, who elected to not treat the pe at that time.After 10 more minutes and the administration of 100 mg of thrombolytics, the patient was successfully resuscitated.The patient was then transferred to the icu, where she deteriorated again.Additional information has been requested.
Event or Problem Description
Additional information was requested from the user facility, who shared that the patient died on (b)(6), 2020.
Additional Manufacturer Narrative
This supplemental mdr is for the inari clottriever sheath device.Refer to smdr #3011525976-2021-00006 for the other inari device involved in this event.Manufacturer reference #: (b)(4).

• Brand Name: INARI CLOTTRIEVER SHEATH
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9 parker; suite 100; irvine CA 92618
• MDR Report Key: 11219605
• Report Number: 3011525976-2021-00007
• Device Sequence Number: 3494424
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: 00850291007109
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 50-101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INARI CLOTTRIEVER CATHETER
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 96