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 Code	Bacterial Infection (1735)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, aziyo was notified by business partner boston scientific that a patient with a s-icd (pacemaker) implanted on (b)(6) 2021 and aziyo biologics cangaroo envelope (model cmcv-009-xlg, lot number m20d1136513) presented with pocket infection.The aziyo device was explanted as part of the removal of the entire s-icd system on (b)(6) 2021.Patient had a history of previous infection with another implantation of a transvenous device in 2020.Due to ongoing complications, patient requested entire system be removed with no plans for replacement.There was no allegation of cangaroo envelope contributing to possible infection given patient's history of infections with previous devices.
Additional Manufacturer Narrative
No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on 20oct2021, showing that all units were quality released on 14apr2020 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot m20b1081 (prt-20679-04) was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 17mar2020 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.Per the report from the boston scientific sales representative who was present at the time of explant, this infection was limited to the pocket and subcutaneous tissue where the lead was tunneled and was not systemic.The s-icd and the aziyo device were both explanted.The patient had a history of a similar infection with a previous device.He may have had an underlying autoimmune issue leading to a recurrence of the same kind of event.It is also noted that per the instructions for use (ifu - art-20662c) provided with the finished cangaroo envelope device, "infection" is listed as a potential complication associated with this procedure and device usage.

• 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: 12770842
• Report Number: 3005619880-2021-00043
• Device Sequence Number: 3343166
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 00859389005072
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K201313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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: 08/21/2022
• Device Model Number: CMCV-009-XLG
• Device Lot Number: M20D1136
• 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: 10/13/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: S-ICD WITH SUBCUTANEOUS STERNAL ELECTRODES.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male