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

Model Number	CMCV-009-MED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/14/2023
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 10oct2023, showing that all units were quality released on 17jul2023 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 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 also be noted that the patient was initially reported to have a hematoma event.However, with the confirmation of infection, this event was re-categorized as a pocket infection.Intervention included drainage in an office setting and the initiation of oral antibiotics.Drainage culture results were positive for both enterococcus and e.Coli.The specific cause of the reported pocket infection cannot be conclusively determined.
Event or Problem Description
Email from sales rep with adverse event report as follows: pocket infection.Patient had new biv pacemaker placed on (b)(6) 2023 with cangaroo device (model # cmcv-009-med, lot #m23g1206).On (b)(6) 2023, patient was seen in office and noted to have a pocket hematoma.Fluid from hematoma was drained and cultured, with results positive for enterococcus and e.Coli.Patient started on antibiotics and sent home.Doctor reported on (b)(6) 2023 that patient's wound was getting worse and he planned hospital admission following upcoming office visit.Event reported as "possibly related" to cangaroo envelope as well as the procedure to implant it.Physician stated cause may be related to surgical technique as he had a second patient (without cangaroo device) who developed infection with the same bacteria.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL-FTM
• 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
• MDR Report Key: 18143126
• Report Number: 3005619880-2023-00003
• Device Sequence Number: 20844438
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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: 09/24/2025
• Device Model Number: CMCV-009-MED
• Device Lot Number: M23G1206
• 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: BIV PACEMAKER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male