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

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

Patient Problem Hematoma (1884)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

No samples were returned for investigation.Manufacturing review of the cangaroo envelope device history records for the reported event could not be completed as the lot/serial numbers were not provided.It is also noted that per the instructions for use (ifu-art-20828a) provided with the finished cangaroo envelope device, both "infection" and "hematoma" are listed as potential complications associated with this procedure and device usage.It is unknown if the device was explanted.Per the physician, no attempts were made to culture patient's wound for confirmation of infection.No other symptoms were mentioned for the event.Therefore, this event will be reported as a "hematoma" event.Should more information be received indicating the presence of infection, this report will be updated.

Event Description

An aziyo sales manager reported a conversation with a physician on (b)(6) 2021.The physician remarked that he had two (2) patients return "a couple of weeks ago" with "open pockets" following the implant of a pacemaker with an aziyo cangaroo envelope.The physician stated that the incisions were open but not the cangaroo pocket inside.The physician first indicated that the patients were infected.With further questioning, the physician said he had not cultured either patient and that it was possibly just a hematoma event in each case.He sent both patients to the electrophysiology lab for "lead extractions".Multiple attempts to obtain more information from the physician were unsuccessful.This report is regarding 'patient a'.

• 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: 12863128
• MDR Text Key: 284710335
• Report Number: 3005619880-2021-00045
• 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: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• 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
• Date Manufacturer Received: 10/28/2021
• 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; Hospitalization