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

Model Number	44-101
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a 56-year-old female underwent a lower left extremity (lle) deep vein thrombosis (dvt) thrombectomy using inari devices.The patient had pre-existing stents in her lle and underwent a successful lle dvt six months prior.Upon a follow-up visit, it was noted that the same region had thrombosed.Over the first three hours of the thrombectomy, multiple attempts to cross the lesion were made using various wire and catheter combinations, as well as venoplasty.The wire was eventually externalized successfully.Revcore was then introduced, and the coring element was expanded, without the use of intravascular ultrasound (ivus).The device became stuck in an area where the patient's stents overlapped.The catheter was pulled forcefully to free the device.The entire device was able to be removed from the patient without injury, excluding the nose cone.Multiple attempts were made to remove the nose cone; however, they were unsuccessful.The nose cone remains in the patient's vessel, embedded in the patient's stent/clot and is unlikely to mobilize.The case ended with no additional issues.A final venogram revealed there were no flow issues, and the collaterals remained intact.No further intervention was required.
Additional Manufacturer Narrative
The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Additionally, a complaint history review was conducted, and no similar issues have been reported against this lot number.The device has been returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted.The device labeling includes the following warning statements: "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the coring element into the outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel." "when revcore is in the path of an exposed stent with broken/fractured struts, a stent <10mm in diameter, or a stent compressed to <10mm, damage to the stent, the coring element, or dislodgment of the stent, etc.May occur." "before inserting the catheter for use in patients with stents, ensure the guidewire is properly placed, and not threaded or entangled in the wire mesh or lining of the stent." the device labeling instructs the user to "assess the treatment site using intervascular ultrasound (ivus)".Manufacturer reference #: (b)(4).
Additional Manufacturer Narrative
The revcore thrombectomy catheter (revcore) was returned to the manufacturer and evaluated.The catheter was returned without the nose cone (radiopaque tip).Visual inspection of the device revealed no other signs of damage or defects, aside from the missing tip.Appropriate adhesive residue was observed at the correct location at the distal end of the catheter under uv light during adhesive residue testing.Upon rotating the handle knob, the element expanded and contracted as designed.No manufacturing defects were detected at any point during the investigation, no discrepancies or unusual findings were found in the device lot history review, and no similar issues have been reported against this lot number.The investigation concluded that the tip likely separated from the catheter as a result of the device getting caught in torturous anatomy with overlapping stents and the device was likely pulled using excessive force in order to disengage the device from the stent entanglement.The device labeling includes the following warning statements: "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the coring element into the outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel." "when revcore is in the path of an exposed stent with broken/fractured struts, a stent <10mm in diameter, or a stent compressed to <10mm, damage to the stent, the coring element, or dislodgment of the stent, etc.May occur." "before inserting the catheter for use in patients with stents, ensure the guidewire is properly placed, and not threaded or entangled in the wire mesh or lining of the stent." the device labeling instructs the user to "assess the treatment site using intervascular ultrasound (ivus)".Manufacturer reference #: (b)(4).

• Brand Name: REVCORE THROMBECTOMY 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: 20474948
• Report Number: 3020347218-2024-00044
• Device Sequence Number: 7228566
• Product Code: QEW
• UDI-Device Identifier: 00850291007383
• UDI-Public: 00850291007383
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K223609
• 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): 11/14/2024

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?: Yes
• Device Expiration Date: 01/15/2026
• Device Model Number: 44-101
• Device Lot Number: 24010055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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: FLOWSAVER.; PROTRIEVE SHEATH.; TREIVER20.
• Patient Age: 56 YR
• Patient Sex: Female