MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER24; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	22-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/05/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.The device was returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted the case was reviewed by inari's chief medical officer, who concluded that the patient's blood loss and death was potentially the result of user error.Manufacturer reference #: (b)(4).
Event or Problem Description
The patient presented with an intermediate high risk saddle pulmonary embolism.They had symptoms for one day prior to admission and were stable but pre-syncopy.The procedure began with micro-puncture in the right femoral, dilation and introduction of the intri24 sheath, then crossing the right heart with a fully formed pigtail.Pa pressure measurements were taken and heparin was administered as the patient's activated clotting time (act) was below therapeutic levels; then introduction of the amplatz guidewire and triever24 with aspirations on the right side.The triever20 curve, was also used on the right with 5 aspirations.This was followed by using flowtriever xl disks and ft2 to remove a chronic clot, and an additional 2 aspirations.All the blood aspirated was given back through flowsaver.One hour into the procedure the physician wanted to go to the left pulmonary artery, when blood was observed on the floor and table.The patient lost a lot of blood in seconds, probably through the open side port valve of the intri24 sheath.The patient went into cardiac arrest because of severe blood loss.After cpr and blood transfusion they wanted to continue the thrombectomy, but the patient crashed again.Following the 3 cardiac arrests the physicians and family decided to stop life saving measures.Additional follow up with the inari account manager post-procedure indicated the blood loss was likely through a sideport valve that was inadvertently left open on either the triever24 or triever20 curve.There was no allegation of a device malfunction from the treating physician.
Additional Manufacturer Narrative
The triever24 (t24) was returned to the manufacturer and evaluated.Visual inspection of the device was performed which revealed no apparent signs of damage to the hemostasis valve and stopcock.No signs of mishandling were observed.The hemostasis valve side buttons were cycled several times and appear to be functioning.The tubing connected to the stopcock bard(s) was inspected for a uniform bond around the circumference of the joint.No disruptions in the adhesive were observed.The t24 tip damage may be attributed to excessive force.The device was pressure and vacuum tested.The tests consist of pressurizing the device to 5psi and pulling vacuum with a 60cc syringe (~ 18 inhg) over 15 seconds without any pressure/vacuum loss.The tests were conducted separately.Upon completion of the tests, no vacuum/pressure decay was observed that exceeded the acceptable leak rate.The performance tests were validated and confirmed passing results.The water pressurization of the t24 was performed with the dilator loaded in the t24 and attaching a large bore syringe to quickly connect of the side port, ensuring the stopcock is in the open position.After pressurizing the t24 slowly, no fluid leak was observed.Disassembling the garrote valve also showed no sign of any malfunction.The septum in the valve appeared to be in good condition.Overall, the root cause could not be attributed to a t24 leakage or malfunction.No evidence of device malfunction was discovered.The case was reviewed by inari's chief medical officer, who concluded that the patient's blood loss and death was potentially the result of user error.The device labeling instructs the user to close the stopcock after flushing the device and after performing an aspiration.Manufacturer reference #: (b)(4).

• Brand Name: TRIEVER24
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer Contact: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 20375355
• Report Number: 3020347218-2024-00042
• Device Sequence Number: 15172988
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K211013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 12/04/2025
• Device Model Number: 22-101
• Device Lot Number: 23120010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLOWTRIEVER XL DISCS; FLOWTRIEVER2; INTR24 SHEATH; INTRI24 SHEATH; TRIEVER20 CURVE
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male