MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CANGAROO; 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	Bacterial Infection (1735)
Date of Event	09/21/2021
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 30sep2021, showing that all units were quality released on 01apr2021 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot m21a1023 ((b)(4)) was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 12feb2021 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 (ifu - art-20828a) 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
On september 24, 2021, aziyo was notified by business partner boston scientific that a patient with a cardiac implantable electronic device and aziyo biologics cangaroo envelope (model cmcv-009-lrg, lot number m21c1118(546), both implanted on (b)(6) 2021, presented to the emergency department on (b)(6) 2021 with a pocket infection.The patient was started on iv clindamycin and vancomycin.The aziyo envelope device was explanted as part of a pocket revision on (b)(6) 2021.Cultures of the pocket taken at the time of explant showed "no growth" on day 3.Device reimplanted on contralateral side on (b)(6) 2021.Explant site looked good and drain removed at that time.Patient is currently doing well.

• Brand Name: CANGAROO
• Common Device Name: MESH-SURGICAL-FTM
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 12672390
• Report Number: 3005619880-2021-00035
• Device Sequence Number: 4233116
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 07/14/2023
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M21C1118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/21/2021
• 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: 70 YR
• Patient Weight: 71