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	Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930)
Date of Event	02/22/2022
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, showing that all units were quality released on 29-dec-2020 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot review was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 1-jun-2020 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 noted that per the instructions for use (ifu - art-20662c) provided with the finished cangaroo envelope device, "hematoma" and "infection" are listed as potential complications associated with this procedure and device usage.The cause of the initial hematoma event was attributed by the physician's office to the patient's anticoagulopathy and was procedure-related.The wound dehiscence likely was caused by the pocket infection.Both the dehiscence and the infection may have been caused by the initial incision and drainage of the hematoma.
Event or Problem Description
On (b)(6) 2022, aziyo was notified by business partner boston scientific that a patient with a cied (cardiovascular implantable electronic device) and an aziyo biologics cangaroo envelope (model cmcv-009-xlg, lot number m20n1423579) implanted on (b)(6) 2021, presented with pocket infection and wound dehiscence.Dehiscence first noted on (b)(6) 2022 and device eventually protruded though the skin.The aziyo device was explanted with the removal of the cied on (b)(6) 2022.

• 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
• Manufacturer (Section G): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• Manufacturer Contact: michael hennick ; 1100 old ellis road; ste 1200; roswell, GA 30076
• MDR Report Key: 13932745
• Report Number: 3005619880-2022-00008
• Device Sequence Number: 11734690
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 00859389005072
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

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: M20N1423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male