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

Model Number	CMCV-009-XLG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930)
Date of Event	02/10/2021
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 12/10/2020 having met all internal manufacturing specifications and qc acceptance requirements for workmanship.All sterilization processing records and bioburden testing indicated 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-conformance's during manufacturing or sterilization potentially impacting the final acceptance of this manufacturing lot.There were no deviations identified in this lot history record.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.The instructions for use for the cangaroo envelope ((b)(4)) in use at the time of product shipment lists risk of hematoma and infection as potential complications.No additional details are available, should any additional information be obtained regarding this event, a follow-up report will be filed.
Event or Problem Description
It was reported on (b)(6) 2021 by aziyo business partner boston scientific that a cangaroo envelope (model cmcv-009-xlg, lot# m20n1387) was used in an icd replacement procedure on (b)(6) 2021 for a (b)(6) year-old male.Envelope was prepared by soaking in ancef/gentamicin/saline.Patient developed hematoma and pocket infection and went to (b)(6) hospital where the icd was explanted on (b)(6) 2021.It was reported that the cangaroo envelope was not removed.Patient was treated with antibiotics and doing well.New implant was performed two (2) days later in different site.

• 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: 11541480
• Report Number: 3005619880-2021-00003
• Device Sequence Number: 4087395
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 0100859389005072
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: 11/06/2022
• Device Model Number: CMCV-009-XLG
• Device Lot Number: M20N1387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/22/2021
• 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
• Patient Age: 66 YR
• Patient Weight: 79