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	Cellulitis (1768)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the elupro antibiotic-eluting bioenvelope device history record was completed on 08apr2026 and identified no quality issues or nonconformances during processing of the final packaged lot or sterile subassembly lot.All drug performance testing met established qa release criteria for assay, elution profile, impurities and endotoxin testing.It is noted that the instructions for use (ifu - art20837 rev.A) provided with each elupro bioenvelope device lists inflammation and infection as potential complications associated with device usage and a cied implantation procedure.No further details are available regarding the reported event.
Event or Problem Description
It was reported via the elupro antibiotic-eluting bioenvelope registry post market clinical study that a 71 yr.Old male patient (subj.(b)(6) underwent a battery/generator change-out procedure on (b)(6) 2025 using an elupro bioenvelope (model # cmcv-124-lrg; lot #m25b1030).A combination of saline and irrisept were utilized to rehydrate the elupro device for 5 seconds.No concerns or complaints were reported during or after the implantation was complete.On (b)(6) 2025, it was reported that the patient experienced an adverse event of possible cellulitis, with no pocket infection observed.The patient was prescribed 100mg doxycycline.The adverse event was suspected to be possibly related to both the cied procedure and the elupro bioenvelope device.At subsequent patient follow-up, the reported cellulitis had resolved without sequelae, no further information is available regarding this event, should any additional information be received, a follow-up report will be submitted.

• Brand Name: ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE
• Common Device Name: CANGAROO RM ANTIBACTERIAL ENVELOPE
• Manufacturer (Section D): ELUTIA INC.; 1100 old ellis rd.; ste. 1200; roswell GA 30076
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION - ROSWELL; 1100 old ellis road; ste. 1200; roswell GA 30076
• Manufacturer Contact: courtney payne ; 1100 old ellis rd.; ste. 1200; roswell, GA 30076 ; 8882721001
• MDR Report Key: 24824269
• Report Number: 3005619880-2026-50003
• Device Sequence Number: 13373590
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: 11/04/2025
• Device Model Number: CMCV-124-LRG
• Device Lot Number: M25B1030
• 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: 12/18/2025
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White