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

Model Number	CMCV-124-LRG
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Elutia lhr review completed on 16-jan-2025 for lot m24l1303 and subassembly lot m24k1270.No discrepancies in the manufacturing process were noted in either batch record during review.It is noted that per the instructions for use (ifu - art-20837 rev.A, ifu elupro antibiotic-eluting bioenvelope) provided with the finished elupro device, "undesired remodeling" is listed within the potential complications associated with device usage.Lead dislodgement is a known complication with the implant of a cadiac implantable device for cardiac surgical procedure.Initial report filed 17jan2025, however submission failed, review of acknowledgements reflected duplicate report.Report resubmitted on 19feb2025 to correct initial submission error.
Event or Problem Description
Sales representative notified by physician that a female patient presented with a dislodged lead for cardiac implantable device data/check and came in for a lead revision on (b)(6) 2024.Original device used was an elupro antibiotic-eluting bioenvelope (model # cmcv-124-lrg, lot # m24l1303).The elupro bioenvelope including disc and pouch suture (all part of elupro bioenvelope) was gone except for tissue paper-like remnants.The cardiac implantable device had dropped in the pocket and the leads were not neat.The patient's tissue was friable.Vicryl suture was still in the pocket.Surgical intervention was required where the lead was re-attached to the heart and a cangaroo envelope device was used to re-implant the cardiac implantable device.

• Brand Name: ELUPRO ANTIBIOTIC-ELUTING BIOENVLOPE
• Common Device Name: CANGAROO RM ANTIBACTERIAL ENVELOPE
• 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 30076 ; 4705144023
• MDR Report Key: 21417436
• Report Number: 3005619880-2025-00004
• Device Sequence Number: 7746536
• Product Code: FTM
• UDI-Device Identifier: 00859389005348
• UDI-Public: 00859389005348
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K233991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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: 06/27/2025
• Device Model Number: CMCV-124-LRG
• Device Lot Number: M24L1303
• 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: 12/20/2024
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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: Female