MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA-6F; CATHETER INTRAVASCULAR DIAGNOSTIC

Model Number	DA6115ST-GC-OD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional 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 was discarded and therefore not available for return and investigation by the manufacturer.However, imaging was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
It was reported through the sofast study that imaging taken one day post thrombectomy revealed re-occlusion of distal left m1 segment.Further intervention via thrombectomy was decided to be futile and decision was made not to re-treat and placed the patient on medication only.The clinician noted that the re-occlusion may have occurred due to intracranial atherosclerosis.The event was possibly related to the study disease and possibly to concurrent condition.The event outcome is ongoing.
Additional Manufacturer Narrative
Two radiographic images were provided for review.The first image is a ct head scan, axial, no contrast, single slice at the level of the lateral ventricles.The image is very grainy.Even though the event description says that the vessel that remained occluded is the distal left m1, a definite infarct could not be seen on this single slice.One slice is not sufficient to determine the status of the brain.The second image is a ct head scan, coronal, no contrast, single slice at the level of the choroid plexus of the lateral ventricles.The image is very grainy.Even though the event description says that the vessel that remained occluded is the distal left m1, a definite infarct could not be seen on this single slice.One slice is not sufficient to determine the status of the brain.These images do not explain why the m1 reoccluded after the thrombectomy.Without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.
Event or Problem Description
N/a.
Event or Problem Description
It was reported "sofast clinical study" imaging after initial thrombectomy on 17jul2023 had shown persistent re-occlusion of m1 segment on 18jul2023.Further intervention via thrombectomy was decided to be futile and more harmful so decision was made not to re-treat.Subject started plavix.
Additional Manufacturer Narrative
Udi related data quality updates only we have identified and updated the information listed under d2a, d2b and h4 nevertheless, please be aware that microvention is still working on updating the gudid website.We will notify you once the information has been given to the agency.

• Brand Name: SOFIA-6F
• Common Device Name: CATHETER INTRAVASCULAR DIAGNOSTIC
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92596
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18332278
• Report Number: 2032493-2023-01120
• Device Sequence Number: 20530106
• Product Code: DQO
• UDI-Device Identifier: 00842429108444
• UDI-Public: (01)00842429108444(11)220615(17)250531(10)0000207817
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024
• 2 Devices were Involved in the Event: 1 2

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: 05/31/2025
• Device Model Number: DA6115ST-GC-OD
• Device Lot Number: 0000207817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 11/18/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/25/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Male