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

Model Number CMCV-009-XLG

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

Patient Problem Seroma (2069)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

A review of the complaint log shows that there are no other complaints associated with the parent lot number (m19d1150).Manufacturing review of the device history record for the reported lot shows that all units were quality released on 4/11/19 having met all internal qc acceptance requirements.All sterilization records, and bioburden testing indicate successful sterilization process, and passing lal and product sterility results allowed the lot to be released having met all criteria for manufacturing release.There were no non-conformances associated with the manufacturing lot during production, sterilization and final packaging.The site noted that the event is probably related to the procedure and possibly related to the device.It was also noted that the physician believes the event could be related to the inflammatory response.The exact relationship to the device cannot be conclusively determined.The instructions for use for the cangaroo envelope (art-20662b) under the section, potential complications, states in part, the following device-related complications are possible: allergic reaction to ecm, inflammation, seroma.

Event Description

It was reported that an (b)(6) year old male had a bi-v icd change out on (b)(6) 2019 (cangaroo envelope was soaked in a vancomycin solution for 2 minutes) and presented with puffiness in pocket at device check (approximately one week later).The puffiness did not subside, and the physician diagnosed the puffiness as a seroma.On (b)(6) 2019 the patient underwent seroma evacuation to drain the serous fluid.It is stated that the event was probably related to the procedure and possibly related to the device (envelope).Physicians believes this could be related to the inflammatory response.Patient is stable and pocket swab cultures were negative for any infection.

• Brand Name: CANGAROO ENVELOPE
• Type of Device: MESH, SURGICAL
• 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: andrew green ; 1100 old ellis road; ste 1200; roswell, GA 30076
• MDR Report Key: 8992586
• MDR Text Key: 161956961
• Report Number: 3005619880-2019-00010
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 01008593890050721721100710M19D1150035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: CMCV-009-XLG
• Device Lot Number: M19D1150035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR