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

Model Number	CMCV-009-LRG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Post Operative Wound Infection (2446)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the cangaroo envelope device history record for the reported lot shows that all packaged and labeled units were quality released to distribution on 28jul2020 having met all internal qc acceptance requirements.All sterilization processing records and bioburden testing indicate a successful sterilization cycle and passing results of product lal and sterility samples allowing the subassembly lot to be released for further packaging and labeling having met all criteria for release.There were no non-conformances during manufacturing or sterilization potentially impacting the final acceptance of this manufacturing lot.In lieu of a request for the oem supplier dhr review, it is noted that aziyo processes the non-sterile envelope materials including cutting, suturing, packaging and sterilizing the product.It is also noted that per the instructions for use (ifu - art-20662) provided with the finished cangaroo envelope device, infection is listed as a potential complication associated with the procedure and device.Although the exact cause of the reported infection cannot be conclusively determined, infection is a known complication associated with the use of a cangaroo envelope and a surgical implant procedure.No further details were available for this event, should aziyo receive any additional details related to this event, a supplemental report will be filed.
Event or Problem Description
It was reported on 01mar2021 by aziyo sales representative that the patient had a successful icd generator change-out on (b)(6) 2021 using a cangaroo envelope (model #: cmcv-009-lrg; lot #: m20g1216) having been soaked in saline for 1 - 2 minutes.Following the implant, the patient was subsequently admitted to another hospital for 3 weeks fo an aortic valve repair.The patient subsequently developed an infection as thr doctor reported icd wound was draining yellow pus and patient tested positive for pseudomonas infection so patient was placed on iv antibiotics.On (b)(6) 2021, the icd device and 21-year-old leads were successfully explanted and patient reportedly doing well.Unknown if envelope was explanted with the explant of the icd.No further details were available for this event, should aziyo receive any additional details related to this event, a supplemental report will be filed.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL-FTM
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 11584730
• Report Number: 3005619880-2021-00004
• Device Sequence Number: 19873036
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192616
• 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): 03/29/2021

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: 08/26/2022
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M20G1216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/29/2021
• 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