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U.S. Department of Health and Human Services

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

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AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE MESH, SURGICAL-FTM Back to Search Results
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.
 
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Brand NameCANGAROO ENVELOPE
Type of DeviceMESH, 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 Key11933668
MDR Text Key266394926
Report Number3005619880-2021-00018
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192616
Number of Events Reported1
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 Received06/03/2021
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 Received05/10/2021
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
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