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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

No information was received providing the model or the lot number involved with this procedure.No product was returned to aziyo biologics for investigation.There were few details provided with this complaint and no exact dates were reported for this event.The physician reported that this event was not procedure-related.However, infection is a known risk of any surgical procedure and it is difficult to determine the exact cause and to rule out any relationship to the procedure, due to exposure from the incision and the intrusion into the subcutaneous layers by external devices and personnel.Microorganisms can be introduced during the procedure and when the pocket is closed, the internal environment is advantageous for growth of infection.It is not possible to determine if the aziyo product was related to this event or if this was procedure-related, caused by trauma to the site, or due to an underlying patient condition.It is noted that, per the instructions for use provided with the finished aziyo cangaroo envelope device, 'infection' is listed as a potential complication associated with this procedure and device usage.

Event Description

Received report from aziyo sales representative.During a site visit, physician reported to the sales representative that he had implanted an aziyo cangaroo device during an intracardiac device (icd) generator change (b)(6) 2021.In (b)(6) 2021, patient developed a pocket infection with fever and pus at wound site.Explant was performed.The physician reported that he believed this infection possibly might have been related to the aziyo cangaroo device because it was his first experience with a pocket infection 3-months post-implant and the placement of the aziyo cangaroo device was the only thing he said was different from his usual process.He also reported formation of a device capsule as a possible cause.Exact dates of implant and explant were not provided by the physician.

• 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: 14830014
• MDR Text Key: 295049109
• Report Number: 3005619880-2022-00015
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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