MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER20; EMBOLECTOMY CATHETER

Model Number	21-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Death (1802); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/14/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The inari device was discarded by the user facility and is therefore not available for analysis.The device history records for this manufacturing lot were reviewed and there were no anomalies, discrepancies, or non-conformances.The labeling includes the following warning statement: "excessive force against resistance may result in damage to the device or vessel perforation." the root cause analysis performed by the inari medical monitor concluded the event was attributed to use error, specifically: when trying to advance the triever20 thrombectomy catheter to the right pulmonary artery, the primary operator did not have enough distal purchase with the abbott supracore 300 guidewire, which has a floppy tip.Advancing the guidewire an additional 15 cm would have created a stable rail required to advance the triever20; however, the operator continued to advance the triever20 laterally, which more than likely caused the perforated right ventricle.Cardiac perforation, pericardial effusion, and death are listed in the device labeling as potential complications associated with thrombectomy/embolectomy procedures.Manufacturer reference #: (b)(4).
Event or Problem Description
On (b)(6) 2019, a (b)(6) year-old female patient was diagnosed with an acute pulmonary embolism via ct angiogram with the presence of bilateral thrombus and right heart strain; the patient also had preexisting deep vein thrombosis (the plan was to place an ivc filter immediately following pulmonary thrombectomy).Two days prior, the patient had undergone exploratory laparotomy and sigmoid colectomy.Vascular access was gained via the right common femoral vein.A rosen guidewire (cook medical) with angled pigtail catheter was used to cross the heart and access the main pulmonary artery.The pigtail catheter was then swapped for a cobra c2 catheter (merit medical).The rosen guidewire was swapped for a supracore 300 cm guidewire (abbott).A dryseal 20 fr introducer sheath (gore) was placed into the right common femoral vein into which the triever20 (inari medical) was advanced through the right atrium into the right ventricle.However, the triever20 was unable to be advanced into the pulmonary valve or pulmonary artery.The primary operator thought that the guidewire had bent and requested a new supracore 300 cm wire.While retracting the triever20 out of the right ventricle the patient started decompensating and arrested.A code was called, anesthesia was immediately administered/patient intubated, vasopressors were administered, and chest compressions were initiated.After approximately 10 minutes of compressions, the patient briefly stabilized and there was discussion that potentially the dvt thrombus had embolized, causing a massive pulmonary embolism.Right internal jugular access was gained and 10 mg of tpa was administered into the main pulmonary artery.Cardiology performed an echocardiogram where it was determined the patient had suffered a pericardial effusion.Emergency pericardiocentesis was performed where a significant volume of blood was removed.Ultimately, the team was unable to stabilize the patient and after approximately one hour of manual compressions, anesthesia pronounced death.

• Brand Name: TRIEVER20
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9272 jeronimo road; suite 124; irvine CA 92618
• MDR Report Key: 9014654
• Report Number: 3011525976-2019-00004
• Device Sequence Number: 2155949
• Product Code: DXE
• UDI-Device Identifier: 00850291007109
• UDI-Public: 00850291007109
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K182233
• 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): 09/12/2019

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: 05/14/2021
• Device Model Number: 21-101
• Device Lot Number: 19050005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Weight: 96