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

Model Number	41-102
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	04/09/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The case was reviewed by inari's chief medical officer, who concluded that the patient's death was the result of inadvertent clot embolism.Distal embolization of blood clots and cardiovascular collapse are identified in the device labeling as possible adverse events/complications.The device instructions for use includes the following warning statement: avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the collection bag and coring element into the outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel.Manufacturer reference #: (b)(4).
Event or Problem Description
A 39-year-old female patient reported feeling unwell and sought medical attention.Imaging revealed extensive and occlusive iliocaval deep vein thrombosis (dvt) and the patient was scheduled to undergo a dvt thrombectomy using inari devices.The clot age was estimated at 10 days.Prior to the procedure, the patient was placed in the supine position and given local anesthesia with sedation.The protrieve sheath was placed and a triever20 (t20) was placed through the protrieve.Three aspirations were performed starting from the location of the renal veins and moving down with subsequent aspirations.The aspirated blood was filtered through the flowsaver which yielded significant chronic fibrotic clot.A pass was then performed with the clottriever xl catheter (ctxl) which only removed minimal clot.Four passes were then performed with the clottriever bold starting from the right external iliac vein.Subacute-chronic clot was removed from these passes.A venogram was performed which demonstrated improvement in flow, but thrombus remained in the inferior vena cava.The physician decided to retract the ctxl towards the protrieve; however, significant resistance was encountered, and the funnel of the ctxl was unable to be closed over the coring element.The entire system was removed together from the patient.At this time, the patient began to deteriorate and a code was initiated.Cardiopulmonary resuscitation (cpr) was conducted and epinephrine was administered.Attempts were made to obtain access with the intri24 sheath, but there was a confirmed pulmonary occlusion.Access was eventually obtained and an occluded right main pulmonary was aspirated with the t20.Flow was restored but there was no improvement in the patient's condition.Cpr continued for another 40 minutes but the patient expired despite resuscitation efforts.

• Brand Name: CLOTTRIEVER XL CATHETER
• 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: 19274173
• Report Number: 3020347218-2024-00024
• Device Sequence Number: 15310954
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K223210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2025
• Device Model Number: 41-102
• Device Lot Number: 23120064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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: CLOTTRIEVER BOLD CATHETER; PROTRIEVE SHEATH; TRIEVER20
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Death
• Patient Age: 39 YR
• Patient Sex: Female