MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA 6F-125CM STR; PERCUTANEOUS CATHETER

Model Number MV-A6125ST

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Paresis (1998); Thrombus (2101); Disability (2371); Foreign Body In Patient (2687)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has been returned for evaluation.The investigation is currently underway.

Event Description

It was reported that the patient presented with an acute cerebral infarction (ais) and mechanical thrombectomy was performed.During removal of a stent retriever (not an mv device) through the sofia after the 2nd thrombectomy pass, high resistance was felt.A 3rd aspiration was performed, resulting in successful removal of the thrombus and restoration of blood flow.Antiplatelet medication was administered.The day after the procedure, an mri demonstrated a metal artifact in the brain.After an unknown time period, the patient experienced another ais event and another thrombectomy was performed.The majority of the clot was removed from the middle cerebral artery (mca); however, some fragmented clot occluded the anterior cerebral artery and the distal mca.Feedback from the physician on (b)(6) 2020 confirmed that currently the patient's degree of disability is measured as mrs=5 with hemiparesis, and the patient is currently hospitalized.The physician stated that he does not directly relate the cause of the current patient's outcome with the "material" identified by the mra in the brain vessel.

Manufacturer Narrative

The device was returned for evaluation.Visual inspection of the sofia confirmed that the distal end, and 16cm from the distal end, was damaged.The damaged section at 16cm (approximately 0.150-0.160" in length) was missing the coil reinforcement.It was observed that some portion of the inner coil had come unraveled and was able to be visualized through the catheter.Upon dissection, it was confirmed that the sofia inner coil was pulled out of the liner, unraveled, kinked/tangled and broken.The braid wires at that section were also kinked and pulled inward.The direction of the wire/pull seemed to indicate that the wire was pulled distally, possibly due to the 3max advancing through the sofia on the 3rd pass.The wire unraveled from the sofia inner coil was removed and analyzed.It was confirmed that approximately 3 inches of the sofia inner coil is missing from the device.Mri images provided by the customer demonstrate a rounded, dark-shaded artifact in the middle cranial fossa that is consistent with a metal object.Additionally, there are ct images that show a small radio-dense object/structure in the middle cranial fossa.None of these images are distinct enough to determine the make up and identity of the object/structure or to determine if the object identified formed part of the sofia flow plus device.The investigation determined the catheter was likely damaged at the end of the 2nd pass when the trevo was removed from the catheter and the physician indicated high resistance.The ifu for the device warns the user against withdrawing when resistance is felt.Based on the information available, there is no indication as to whether the sofia was inspected for damage after each pass, especially after the 2nd pass.Because the customer-supplied post-procedure images show a radio dense object in the middle cranial fossa and the evaluation of the returned device found a section of the inner coil missing, it is possible that the damaged inner coil eventually broke off during the 3rd pass and was left in patient's vasculature, but this cannot be definitively concluded based on the information available.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.

• Brand Name: SOFIA 6F-125CM STR
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9625000
• MDR Text Key: 189002531
• Report Number: 2032493-2020-00014
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04987892098536
• UDI-Public: (01)04987892098536(11)190424(17)220331(10)190424561
• Combination Product (y/n): N
• PMA/PMN Number: K150366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: MV-A6125ST
• Device Lot Number: 16082209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Date Manufacturer Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other