MAUDE Adverse Event Report: ELUTIA INC. VASCURE FOR VASCULAR REPAIR; PATCH, PLEDGET-INTRACARDIAC-DXZ

Model Number	CMCV-013-609
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample is available for evaluation.Multiple attempts were made to gather more detailed information from dr.(b)(6) with no response to date.It was noted that the original date, ((b)(6) 2024), the incident was processed through a "healthtrust" portal prior to notification to elutia, is being used as the date of event, as the actual date of the event was not able to be confirmed.Manufacturing review of the vascure for vascular repair device history record was completed resulting in no quality issues identified during processing of the lot.Additionally, the subcontractor was asked to perform an evalution of the manufacturing batch records for tissue processing lots used in elutia's manufacturing lot, resulting in no quality issues identified during their manufacturing process.It is noted that per the instructions for use (ifu - art-20708 rev.A, ifu vascure for vascular repair) provided with the finished vascure for vascular repair device, that an aneurysm is identified in the instructions for use as a known potential complication associated with carotid artery / vascular surgical procedures and device usage.
Event or Problem Description
A report was received from elutia's business partner on 17-december-2024 of two (2) adverse events related to patients having been implanted with vascure for vascular repair patch (1cm x 10cm) developing aneurysms after implant.The reported events will be filed in 2 different adverse event reports specific to the patient and reported elutia product information.A 1cm x 10cm size vascure for vascular repair patch (model # cmcv-013-609, lot m24d1113) was used to treat patient #2 and is the subject of this report.The second event (patient #2) will be addressed in.Multiple attempts have been made to gather additional information from the implanting physician with no further information having been received.Should additional information be received, a follow up report will be filed.

• Brand Name: VASCURE FOR VASCULAR REPAIR
• Common Device Name: PATCH, PLEDGET-INTRACARDIAC-DXZ
• Manufacturer (Section D): ELUTIA INC.; 1100 old ellis road; ste. 1200; roswell GA 30076
• Manufacturer (Section G): ELUTIA INC.; 1100 old ellis road; ste. 1200; roswell GA 30076
• Manufacturer Contact: michael hennick ; 1100 old ellis road; ste. 1200; roswell, GA 30076 ; 4705144085
• MDR Report Key: 21163855
• Report Number: 3005619880-2025-00002
• Device Sequence Number: 9355575
• Product Code: DXZ
• UDI-Device Identifier: 00859389005140
• UDI-Public: 00859389005140
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: CMCV-013-609
• Device Lot Number: M24D1113
• 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: 12/17/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown