MAUDE Adverse Event Report: AZIYO BIOLOGICS, 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	Bacterial Infection (1735); Seroma (2069)
Date of Event	01/10/2022
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 21jan2022, showing that all units were quality released on 11jun2021 having met all internal qc acceptance requirements.There were no non-conformance's associated with the manufacturing lot during the final packaging.Sterile subassembly lot m21b1059 ((b)(4)) was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 09mar2021 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 - (b)(4)) provided with the finished cangaroo envelope device, infection is listed as a potential complication associated with this procedure and device usage.It is also noted that the instructions for use specify the use of room temperature sterile water, sterile saline or sterile lactated ringers to hydrate the product for 1-2 minutes prior to use.The physician used vancomycin, soaking for 2 minutes.Although the exact cause of the reported issue cannot be conclusively determined, the reported infection is a known complication associated with the use of a cangaroo envelope and a surgical implant procedure.The bacterium propionibacterium acnes is a gram-positive human skin commensal (shelters in and feeds on the host without damage to the host) microbe.Since it is harbored in the skin, the likelihood of the origin of infection is from the patient herself.It prefers anaerobic growth conditions, such as those provided within an icd pocket.Self-infection is an understood risk of any invasive procedure, despite efforts to "sterilize" the skin.Should aziyo receive any additional details related to this event, a supplemental report will be filed.
Event or Problem Description
Notified by email from aziyo sales rep regarding a patient who received an icd generator change with implant of cangaroo envelope (model cmcv-009-xxl, lot m21f1209) on (b)(6) 2021.Seroma noted (b)(6) 2021.Device explanted (b)(6) 2022.Cultures returned positive for propionibacterium acne.

• 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: 13393076
• Report Number: 3005619880-2022-00004
• Device Sequence Number: 14419927
• Product Code: FTM
• UDI-Device Identifier: 00859389005119
• UDI-Public: 00859389005119
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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: 08/12/2023
• Device Model Number: CMCV-009-XXL
• Device Lot Number: M21F1209
• 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: 01/07/2022
• Initial Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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: 39 YR
• Patient Sex: Female