MAUDE Adverse Event Report: INARI MEDICAL - OAK CANYON FLOW TRIEVER INARI MEDICAL; CATHETER, EMBOLECTOMY

Model Number CATH FLOWTRIEVER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Exsanguination (1841); Diminished Pulse Pressure (2606); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/27/2021

Event Type  Death  

Event Description

Covid-19 vaccine: dose 3 given (b)(6) 2021, refer to guidelines.Care team: no pcp.Coverage: (b)(6).Allergies: (4), ht: 1.575 m (5' 2"); bmi: 32.67 kg/m2.This was an (b)(6) years old female with pmhx of htn, depression, kyphoscoliosis, oa, glaucoma presented with exertional dyspnea , presented to emergency room and found to have elevated troponin to >500 & bnp 186, initially though to have nstemi but on same admission day evening nstemi diagnosis ruled out as she was diagnosed with pe which explained her troponin elevation.Cta report showed (acute pulmonary artery thromboembolism identified in the proximal right main pulmonary artery beginning at the level of the left and right main pulmonary artery bifurcation extending into the truncus anterior and interlobar artery and into the segmental branches of the right upper and middle lobes, and posterior basal segments of the right lower lobe.Acute pulmonary arterial thrombus embolism identified in the distal left main pulmonary artery extending into the left upper lobe and lingular branches and a left lower lobe basal segmental artery.Patient went to interventional radiology department for the procedure (b)(6) 2021 , unfortunately developed acute pulmonary hemorrhage intra-procedure and lost bp and pulse, code blue called during code blue patient was given multiple blood transfusions and other meds, she was intubated, had cpr, had emergent thoracotomy by thoracic surgery in ir department in attempt to control her pulmonary hemorrhage, yet all attempts failed to achieve return of spontaneous circulation (rosc).Code blue ended per icu intensivist who pronounced patient dead at 1:25 pm on (b)(6) 2021.

• Brand Name: FLOW TRIEVER INARI MEDICAL
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): INARI MEDICAL - OAK CANYON
• MDR Report Key: 12770527
• MDR Text Key: 280459447
• Report Number: MW5105146
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: CATH FLOWTRIEVER
• Device Catalogue Number: #21-101
• Device Lot Number: ASP GUIDE 20F
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 81 KG