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

Model Number CMCV-009-XLG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

No sample was returned for evaluation. Manufacturing review of the referenced lot number and respective device history record was conducted on 8sep2021, showing that all units were quality released on 13apr2021 having met all internal qc acceptance requirements. There was one non-conformance associated with the manufacturing lot during the final packaging which was addressed through a nonconforming materials report. It was resolved and was unrelated to the reported adverse event. Sterile subassembly lot m20m1337 (prt-20679-09) was also reviewed for potential issues impacting the quality of this product. This subassembly lot was released to component inventory on 30nov2020 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 also noted that per the instructions for use (ifu - art-20662c) provided with the finished cangaroo envelope device, "inflammation" is listed as a potential complication associated with this procedure and device usage.

Event Description

On (b)(6) 2021 a patient had an icd change out procedure which included an aziyo biologics cangaroo envelope model cmcv-009-xlg lot number m21d1130. On (b)(6) 2021 the patient had a pocket revision procedure performed due to redness and swelling at the site of the pocket revision. Remnants of the aziyo cangaroo envelope were removed at that time.

• Brand Name: CANGAROO ENVELOPE
• Type of Device: 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: 12543720
• MDR Text Key: 273686420
• Report Number: 3005619880-2021-00030
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CMCV-009-XLG
• Device Lot Number: M21D1130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/28/2021 Patient Sequence Number: 1