MAUDE Adverse Event Report: MICROVENTION, INC SOFIA FLOW PLUS 6F; CATHETER, THROMBUS RETRIEVER

Model Number	DA6125ST
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/03/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.The investigation is currently underway.The instructions for use (ifu) identifies death as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during a thrombectomy the microcatheter was advanced with resistance due to cervical kinking.The microcatheter was advanced through the sofia during the second maneuver, however, resistance was again encountered distally.Recanalization was achieved, but there was remaining occlusion distally with complete closure of the vessel.The surgeon reported a thread-like, elongated elastic material in the distal ica, which he described as a thrombus.The material was inspected by the hospital and determined to be "organic," but its origin has not yet been evaluated by the manufacturer.It was reported that the patient later passed away.
Additional Manufacturer Narrative
The sofia aspiration catheter and a portion of the thread-like thrombus were received for evaluation.Damage was found along the distal end of the catheter and kinks were found along the shaft.The conditions or circumstances that led to the damage could not be identified, but the damage is consistent with the device experiencing forces over specification.The thread-like material was analyzed with ftir and found to be gelatin.Gelatin is not used during the manufacturing process of the catheter.The source of the material is unknown.

• Brand Name: SOFIA FLOW PLUS 6F
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 11822560
• Report Number: 2032493-2021-00175
• Device Sequence Number: 11873130
• Product Code: NRY
• UDI-Device Identifier: 00812636020426
• UDI-Public: (01)00812636020426(11)200728(17)230630(10)200728533
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 06/30/2023
• Device Model Number: DA6125ST
• Device Catalogue Number: DA6125ST
• Device Lot Number: 200728533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death