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	Unspecified Infection (1930)
Date of Event	09/28/2021
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 6oct2021, showing that all units were quality released on 7apr2021 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 (prt-20679-03) 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
It was reported by an aziyo sales rep that a patient with a cardiovascular implantable electrical device (cied) with accompanying aziyo cangaroo envelope (model cmcv-009-lrg, lot m21d1128(065)) had an explant of both devices due to pocket infection on (b)(6) 2021.Date of original implant was (b)(6) 2021.Patient experienced early post-operative pain and approximately a week later had pus draining from the incision.Physician does not believe the aziyo device was the cause of the infection but it cannot be ruled out.New placement of cied system planned at a later date on contralateral side.Accompanying implanted/explanted device was biotronik acticor 7vr-t dx.

• 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: 12675139
• Report Number: 3005619880-2021-00038
• Device Sequence Number: 16812723
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: company representative,health
• 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: M21D1128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BIOTRONIK ACTICOR 7VR-T DX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR