MAUDE Adverse Event Report: ELUTIA INC. CANGAROO ENVELOPE; MESH, SURGICAL-FTM

Model Number	CMCV-009-XXL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on (b)(6) 2023, showing that all units were quality released on (b)(6) 2023 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory, having met all quality requirements including product sterility testing following eo sterilization, as well as internal bioburden and product pyrogen (lal) testing requirements.In lieu of a request for the oem supplier for a dhr review of the ecm material lots, it is noted that elutia processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing.It is also noted that per the instructions for use (ifu - art-20828a) provided with the finished cangaroo envelope device, "infection" is listed as a potential complication associated with this device and the surgical procedure to implant it.It should be noted that the presence of infection was not confirmed.Antibiotics were started post-operatively, likely due to the patient's elevated temperature.When the drainage was ultimately cultured, cultures were negative.The presence of other symptoms, such as copious amounts of purulence, and the need for a wound vac, support the likelihood of infection as the source of the explantation.The specific cause of the pocket infection cannot be conclusively determined.However, the physician reported that he believed the icd was "definitely related" to the infection and he was unsure if the cangaroo envelope was related.
Event or Problem Description
Email received from sales rep with adverse event report as follows: pocket infection.65-year old male had subq icd (boston scientific) device placed (b)(6) 2023 using the cangaroo envelope (cmcv-009-xxl, lot #m23f1182).Patient became febrile within 24 hours and was placed on two antibiotics post-operatively.Icd and cangaroo explanted (b)(6) 2023 for pocket infection, with approximately 500cc of pus removed.Cultures were performed and results were negative.Patient received a wound vac for the site of the explant and plan is to send patient home eventually with a life vest.Explanting physician stated that infection was "definitely related" to the icd device but could not rule out involvement of the cangaroo envelope.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL-FTM
• 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
• MDR Report Key: 18143012
• Report Number: 3005619880-2023-00002
• Device Sequence Number: 6560149
• Product Code: FTM
• UDI-Device Identifier: 00859389005119
• UDI-Public: 00859389005119
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K201313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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: 09/13/2025
• Device Model Number: CMCV-009-XXL
• Device Lot Number: M23F1182
• 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: 10/06/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC SUBQ ICD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male