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

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

Patient Problems Bacterial Infection (1735); Hematoma (1884)

Event Date 01/31/2021

Event Type  Injury  

Manufacturer Narrative

No sample was returned for investigation. Manufacturing review of the cangaroo envelope device history record for the reported lot could not be completed as the model/lot numbers were not provided. Based on the available information, the exact cause for the potential issue of pocket hematoma and infection cannot be conclusively determined. However, due to the patient and family history, it can be deduced that these were non-device related events. The patient had a history of post-op infections for each of his knee surgeries as well as following his first pacemaker insertion. There was also a family history of autoimmune deficiency. This infection did not become evident until six weeks post-op, after the usual post-op antibiotic course would typically be completed. Although treated systemically with iv antibiotics, there was no mention of any symptoms beyond the local site itself. A review of the instructions for use provided with the cangaroo envelope product (part number - art 20662c) states under the section for potential complications: the following procedure-related complications are possible: hematoma and infection. No further information is available regarding the reported events. Should any additional information be received, a follow-up report will be filed.

Event Description

Through post market surveillance, the following case study was identified and reviewed, entitled (b)(6) cureus 13(1), 20jan2021. The details are summarized as follows: a (b)(6) year-old male with a history of coronary atherosclerosis, hypertension, hyperlipidemia, congestive heart failure and need for chronic ventricular pacing in addition to a prior history of sequential knee replacements with post-op infections in each knee, family history of immunoglobin deficiencies and a prior dual chamber pacemaker infection treated with course of oral antibiotics to resolve. Patient required a device upgrade for cardiac resyncronization therapy (crt) and device implanted using a cangaroo envelope (model #: unknown, lot #: unknown) due to the patient's history of prior infection. Six weeks after upgrade, patient was admitted to the hospital for a hematoma and suspected infection of the device pocket and incision. Extraction of complete system was performed, and cultures obtained from the leads identified acid-fast bacilli along with gram-negative rods. After a regimen of broad-spectrum intravenous antibiotics, the patient underwent device reimplantation on the contralateral side and has reported no further complications six-months post-op. Follow-up attempts to contact physician for more information, including model/lot numbers were unsuccessful. Should aziyo receive any additional details relating to the reported event, a follow-up report will be filed.

• 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: 11933668
• MDR Text Key: 266394926
• Report Number: 3005619880-2021-00018
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 05/10/2021
• 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 Treatment Data

Date Received: 06/03/2021 Patient Sequence Number: 1