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

Model Number	CMCV-009-LRG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	11/17/2023
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 14dec2023, showing that all units were quality released on 30jul2021, 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 on 22jun2021, 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 (formerly aziyo) processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing.The report includes the physician speculating that both the procedure and the device could possibly be related to the event.He questioned whether or not the fellow's surgical technique could have been a contributing factor as well as the patient's habitus.The patient was reported to be elderly and have thin skin.It was implied that this was the reason the fellow chose to use the cangaroo device for the first time in his practice.No report of infection or other complication was reported.The use of the cangaroo device unfortunately did not prevent the erosion of the pocket and may have contributed to the event due to the placement of more product under the already fragile skin or the remodeling over four months that reduced the integrity of the pocket needed to keep the device supported and intact.Ineffective skin closure of the pocket with sutures could also have been a contributing factor.It is noted that per the instructions for use provided with the finished cangaroo envelope device, "undesired remodeling" is listed as a potential complication associated with this procedure and device usage.
Event or Problem Description
Email from elutia sales representative reporting "erosion of device." male patient had new biv pacer implanted (b)(6) 2023 using the cangaroo envelope (model # cmcv-009-lrg, lot # m21g1274).Both biv pacer and cangaroo envelope were explanted (b)(6) 2023 due to erosion of the device.Physician reported the possible cause of the event as "[fellow] has only implanted a cangaroo once, used it for an elderly patient that had thin skin, not sure what to think, maybe the fellow's technique closing the pocket could have something to do with it." he further stated that because this was the first time he had had a cangaroo placed in a patient, and the fellow had not previously used one or been trained on its implantation, he could not speak to remodeling, migration, or erosion with the use of this device.Event relationship to both procedure and aziyo device reported as "possibly related." patient received medication in addition to explant, is reported as doing well, and is scheduled to have pacemaker implant on contralateral side.

• 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: 18344337
• Report Number: 3005619880-2023-00008
• Device Sequence Number: 17532027
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• 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
• 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): 12/18/2023

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: 11/22/2023
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M21G1274
• 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: 11/27/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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 Sex: Male