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

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); Sepsis (2067)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample was returned for investigation.Manufacturing review of the referenced lot number and respective device history record was conducted on 19may2021, showing that all units were quality released on 21july2020 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot m20c1119 was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 22apr2020 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 dhr review, it is noted that aziyo processes the non-sterile envelope materials including cutting, suturing, packaging and sterilizing the product.A review of the instructions for use (ifu-art-20662c) provided with the finished cangaroo envelope device states under the section potential complications: the following device-related complication is possible: infection.Although distributor reported this as an "infection with sepsis," it is known that the distributor is unable to differentiate between pocket infection and sepsis in their reporting.In the absence of further details from the physician, it is not possible to determine if this was a pocket infection or actually sepsis.The device was explanted and the patient was put on iv antibiotics.Should aziyo receive any additional information related to this event, a follow-up report will be submitted.
Event or Problem Description
It was reported by aziyo's business partner, boston scientific, that a cangaroo envelope (model #: cmcv-009-med / lot #: m20g1215) was explanted on (b)(6) 2021 due to infection.Additional information received from business partner reported that this was an "infection with sepsis" and the patient was placed on iv antibiotics.The initial implant of the cangaroo envelope and pacemaker was performed on (b)(6) 2021.Multiple attempts were made to confirm sepsis report and to get additional information from implanting physician, but were unsuccessful.Should aziyo receive any additional information regarding the reported event, an update report will be submitted.

• 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: 11987144
• Report Number: 3005619880-2021-00020
• Device Sequence Number: 3363498
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• 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: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

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: 09/22/2022
• Device Model Number: CMCV-009-MED
• Device Lot Number: M20G1215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/11/2021
• 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