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

Model Number 50-101

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Death (1802)

Event Date 01/15/2019

Event Type  Death  

Manufacturer Narrative

The inari devices used were discarded by the user facility and are therefore not available for analysis.The device history records for this manufacturing lot were reviewed and there were no anomalies, discrepancies, or non-conformances.It should be noted that the device was used 12 days beyond the labeled expiration date; however, there was no device malfunction and the shelf life for this device has now been extended to 2 years.At this time, the likely root cause of the intraoperative event (cardiac arrest) was the lack of pre-procedure anticoagulation and need for intraoperative bolus injection of heparin through the sheath of un-anticoagulated patient dislodging thrombosed blood into venous vasculature resulting in a pulmonary embolism in a predisposed patient.Use of the device without anticoagulation is contraindicated in the device labeling.The device labeling includes the following contraindication: "not intended for use without anticoagulation.The device labeling includes the embolization of blood clots and cardiovascular collapse as possible adverse events associated with thrombectomy procedures.(b)(4).

Event Description

On (b)(6) 2019, a patient with a history of prior pulmonary embolism events was treated for deep vein thrombosis after being admitted for left leg pain and swelling.The vascular surgeon gained popliteal access via a 0.035" terumo glidewire placed through the inferior vena cava.Clot in the left common iliac, external iliac, and common femoral was identified by ultrasound and verified by venogram.During the procedure, the patient experienced dysrhythmia, likely provoked by the terumo guidewire tip being misplaced in right heart.The inari clottriever sheath was introduced over the preplaced guidewire and the clottriever catheter was inserted through the clottriever sheath upon removal of the sheath's dilator.The first pass with the clottriever catheter successfully removed acute clot.The clottriever catheter was re-introduced and a second pass was completed.At this time it was discovered that the patient had not been anticoagulated pre-procedurally, so with the clottriever catheter outside of the patient, the physician delivered a 10,000 iu bolus injection of heparin via the clottriever sheath side port.The patient then complained she was not feeling well.Hemodynamics remained unchanged from pre-procedural measurements, but within minutes of the heparin injection the patient arrested.A code was called and a pulse was regained during resuscitation.The patient arrested again, cpr was administered, and a pulse was regained for the second time.The crash team cardiologist noted st-segment elevation consistent with myocardial infarction in the right coronary artery.No device malfunction was reported.After the incident, the patient was transferred to the intensive care unit.The treating physician suspected a pulmonary embolism based on right heart strain (determined by echocardiography) and prior medical history, however a confirmatory ct angiogram was not ordered due to the patient's elevated creatinine level.The patient later expired on (b)(6) 2019.

• Brand Name: CLOTTRIEVER SHEATH
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9272 jeronimo road; suite 124; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 9272 jeronimo road; suite 124; irvine CA 92618
• Manufacturer Contact: eben gordon ; 9272 jeronimo road; suite 124; irvine, CA 92618 ; 9496008433
• MDR Report Key: 8329343
• MDR Text Key: 135842874
• Report Number: 3011525976-2019-00001
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00850291007109
• UDI-Public: 00850291007109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2019
• Device Model Number: 50-101
• Device Lot Number: 18070001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 66