MAUDE Adverse Event Report: AZIYO BIOLOGICS, 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	Seroma (2069)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Email received from physician describing the following event: patient underwent a lead revision procedure from a prior icd placement on (b)(6) 2021 utilizing an aziyo cangaroo envelope (cmcv-009-lrg, lot #m21c1109).On (b)(6) 2021, patient reported pocket pain and swelling which was observed at physician's office.On (b)(6) 2021, patient was reevaluated and sent for seroma extraction, at which time a purulent white material without odor was extracted from the pocket.Blood cultures and wound cultures were negative.Icd and leads removed.Patient hospitalized and infectious disease service consulted.Patient placed on iv antibiotics and cleared for re-implant on (b)(6) 2021.
Additional Manufacturer Narrative
No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on 06jan2022, showing that all units were quality released on 26mar2021 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.The sterile subassembly lot was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 11jan2021 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 aziyo 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, "seroma" is listed as a potential complication associated with this procedure and device usage.Although the physician listed the event as "probably related" to the cangaroo device, there are multiple possible causes including: trauma within the pocket (re-entry, cauterization, possible flushing of pocket with antibiotics) leading to weeping of serous/lymphatic drainage into the pocket, an auto-immune response to any of the foreign objects within the pocket, a reaction to the antibiotic used to hydrate the envelope, or possibly a subclinical infection.Although this patient had an infection in a cystic duct of the breast at the time of all testing, the patient was negative for blood and pocket cultures, did not have an elevated wbc, had a negative procalcitonin and was afebrile.Should any additional information be received related to this event, a follow-up report will be submitted.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL-FTM
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• Manufacturer (Section G): AZIYO BIOLOGICS, 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: 13294315
• Report Number: 3005619880-2022-00002
• Device Sequence Number: 4709586
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K201313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 01/19/2022

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: 06/03/2023
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M21C1109
• 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: 12/22/2021
• Initial Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female