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

Model Number	40-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiopulmonary Arrest (1765); Death (1802)
Date of Event	03/11/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was discarded by the user facility and is not available for evaluation.The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.The case was reviewed by inari's chief medical officer, who concluded that the patient suffered a recurrent pe which the clottriever device may have contributed to distal embolization of the dvt clot, leading to the recurrent pe.The inari triever20 is not suspected as a contributing factor.Distal embolization of blood clots and cardiovascular collapse are listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).
Event or Problem Description
A (b)(6)-year-old obese female patient with a history of a bilateral mastectomy (one week prior) and recent neurological changes was diagnosed with acute deep vein thrombosis (dvt).Venograms revealed clot burden in the left iliac veins and left femoral vein.A computed tomography (ct) angiography scan from earlier in the week also indicated the presence of a pulmonary embolism (pe).On (b)(6) 2020, the inari clottriever was used to treat the dvt.After the patient was intubated, access was gained via the left popliteal vein.Three passes with the device were performed with each pass yielding acute, small clot pieces.After the third pass, the clottriever catheter was removed from the patient; as it was being cleaned, the patient's vital signs became unstable and blood pressure decreased.The decompensation was due to a suspected pe (likely attributed to inadvertent dislodgement of the dvt clot).The patient was repositioned from prone to supine, and a cardiologist was called in for assistance.The patient continued to decompensate and arrested.Chest compressions were performed for 15-20 minutes until the patient was stable enough to use the inari triever20 to attempt to remove clot from the right pulmonary artery.The device was able to remove some of the clot, but the patient continued to deteriorate.Chest compressions were reinitiated, but the patient expired despite multiple resuscitation attempts.

• Brand Name: CLOTTRIEVER CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9 parker; suite 100; irvine, ca
• MDR Report Key: 9936087
• Report Number: 3011525976-2020-00006
• Device Sequence Number: 10951280
• Product Code: QEW
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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 Expiration Date: 09/26/2021
• Device Model Number: 40-102
• Device Lot Number: 19090014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/08/2020
• 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: TRIEVER20 (INARI MEDICAL) TO TREAT PE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 55 YR
• Patient Weight: 181