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

Model Number	CMCV-009-XLG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample is available for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on (b)(6) 2021, showing that all units were quality released on (b)(6) 2021 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot m20l1302 ((b)(4)) was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 8dec2020 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 also noted that per the instructions for use ((b)(4)) provided with the finished cangaroo envelope device, infection is listed as a potential complication associated with this procedure and device usage.
Event or Problem Description
Patient had original icd placement in 2016 with icd change-out procedure on (b)(6) 2021.She reportedly went swimming post-surgery and developed some pain, swelling and redness at the site.Antibiotics were prescribed but she delayed taking them for a week.When she presented to the physician, the icd site had an open wound with the device exposed, no redness, some swelling, and yellow drainage.No fever, chills or body aches.Device was explanted along with aziyo envelope.Pocket was irrigated and new icd and aziyo envelope implanted.Patient was discharged home on oral antibiotics.Cutures taken at the time of explant showed "no growth" six days later.

• 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
• MDR Report Key: 12520449
• Report Number: 3005619880-2021-00028
• Device Sequence Number: 4584502
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 00859389005072
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192616
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: 04/02/2023
• Device Model Number: CMCV-009-XLG
• Device Lot Number: M21E1170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Weight: 66