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

Model Number	CMCV-009-MED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pocket Erosion (2013)
Date of Event	08/06/2019
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 5/17/2019 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
It was reported that this product was part of a system revision on (b)(6) 2019 due to infection and erosion.Reportedly, the patient's abdominal implant eroded through the patient's skin and several laboratories with the device were done.Patient device was explanted, and a new pacemaker was implanted.Several laboratories with the device were performed which prompted the physician to extract the patient's device.Leads and cangaroo envelope remained in service.It can be noted that the initial reporter stated the aziyo device was not related to the event.There were no additional adverse patient effects reported.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 9681950
• Report Number: 3005619880-2020-00003
• Device Sequence Number: 3171212
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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: 09/26/2021
• Device Model Number: CMCV-009-MED
• Device Lot Number: M19E1203572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 02/07/2020
• 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: 68 YR