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

Model Number	CMCV-010-XLG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the device history record for the reported lot shows that all units were quality released on 9/9/2019 having met all internal qc acceptance requirements.All sterilization records, and bioburden testing indicate successful sterilization process, and passing lal and product sterility results allowed the lot to be released having met all criteria for manufacturing release.There were no non-conformances associated with the manufacturing lot during production, sterilization and final packaging.In lieu of a request for the oem supplier dhr review, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing.It can be noted that per the instructions for use [ifu] (part number-20663 provided with device) for the cangaroo envelope currently lists infection as a potential complication associated with the procedure and device.Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication with the cangaroo envelope.
Event or Problem Description
Patient had pulse generator and leads explanted due to infection/sepsis.Aziyo product remains in service.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell, ga
• MDR Report Key: 9781984
• Report Number: 3005619880-2020-00022
• Device Sequence Number: 19495663
• Product Code: FTM
• UDI-Device Identifier: 10859389005079
• UDI-Public: 10859389005079
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2022
• Device Model Number: CMCV-010-XLG
• Device Lot Number: M19K1385002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 03/03/2020
• 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: 81 YR