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

Model Number	CMCV-009-MED
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, aziyo was notified by business partner boston scientific that a patient with a cardiovascular implantable electronic device (cied) system had a "pocket revision due to infection" on (b)(6) 2021.The revision included the explantation of the aziyo biologics cangaroo envelope (model cmcv-009-med, lot m21f1242, serial number (b)(4)).Based on the small amount of information obtained from boston scientific, it appears the implantation and explantation of this device was done on the same day.Multiple attempts were made to contact the physician for more details.The physician relayed a message that stated that the pocket revision was "not infection-related." no further details are anticipated.
Additional Manufacturer Narrative
No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on 4oct2021, showing that all units were quality released on 13jul2021 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot m21e1182 ((b)(4)) was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 21jun2021 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.The physician reported that this was a non-infection related event.It is unknown why there was a need for revision but it is unlikely it was due to the aziyo product.

• Brand Name: CANGAROO
• Common Device Name: FTM. SURGICAL MESH
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 12605044
• Report Number: 3005619880-2021-00033
• Device Sequence Number: 1414158
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• 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): 10/11/2021

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: 11/10/2023
• Device Model Number: CMCV-009-MED
• Device Lot Number: M21F1242
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/11/2021
• 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