MAUDE Adverse Event Report: ELUTIA INC. ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE; CANGAROO RM ANTIBACTERIAL ENVELOPE

Model Number	CMCV-124-LRG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Elutia lhr review completed on 08/08/2025 for lot m25a1005 and subassembly lot m24n1343.No discrepancies in the manufacturing process were noted in either batch record during review.It is noted that per the instructions for use (ifu - art20837 rev.A, ifu elupro antibiotic-eluting bioenvelope) provided with the finished elupro device, "hematoma" is listed within the potential complications associated with device usage.Hematoma is a known complication with the implant of a cardiac implantable device for cardiac surgical procedure.
Event or Problem Description
Email was received from the elutia representative regarding a patient in an elutia registry study.It was reported that on (b)(6) 2025, the patient had a pocket revision with a pacemaker implant along with the implant of a large elupro antibiotic-eluting bioenvelope (model cmcv-124-lrg, lot m25a1005).On 06/10/2025, the site became aware (patient onset (b)(6) 2025) that the patient developed a hematoma and was treated with oral antibiotics (doxycycline) and rivaroxaban (held 3 days).After (b)(6) 2025, the patient did not note any symptoms related to a hematoma.The site also noted that the patient did not have any existing conditions or comorbidities which could have contributed to the hematoma.No further details are available regarding this event but if elutia receives more information, a supplemental report will be filed.

• Brand Name: ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE
• Common Device Name: CANGAROO RM ANTIBACTERIAL ENVELOPE
• Manufacturer (Section D): ELUTIA INC.; 1100 old ellis road; ste. 1200; roswell 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 ; 4705144023
• MDR Report Key: 22777214
• Report Number: 3005619880-2025-00007
• Device Sequence Number: 9185090
• Product Code: FTM
• UDI-Device Identifier: 00859389005348
• UDI-Public: 00859389005348
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: 09/29/2025
• Device Model Number: CMCV-124-LRG
• Device Lot Number: M25A1005
• 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: 07/15/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 78 YR
• Patient Sex: Female