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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
Manufacturing review of the cangaroo envelope device history record could not be completed as no lot number was reported. The instructions for use (ifu - art- 20662) provided with the finished cangaroo envelope device lists seroma as a potential complication associated with the procedure and the cangaroo envelope device. As device was used as a barrier to prevent the leads from contacting tissue walls of formed pocket, and not to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body, this event is an unintended use of the cangaroo envelope device. Although the exact cause of the reported seroma event cannot be conclusively determined, seroma is a known complication associated with the use of a cangaroo envelope and a surgical implant procedure. Should aziyo receive any additional details related to this event, a supplemental report will be filed.
 
Event Description
It was reported on 01/21/2021 by aziyo biologics' sales representative, that a cangaroo envelope (model: unknown; lot # unknown) was used in a cied downgrade procedure from an implantable cardiac defibrillator (icd) to a pacemaker. Once inside the pocket, the physician discovered that a vein was occluded resulting in abandoning a lead. The physician used the cangaroo envelope to place on top of the lead before closing the pocket. A separate pocket was formed on the right side of body in which the pacemaker was placed and leads to heart run from right side of body. No cangaroo was used to place the pacemaker into in the newly formed pocket. The patient presented with a very large seroma shortly after the procedure. There has been no intervention at this time - approximately four (4) months post-implant and the seroma still exists. The cangaroo device was hydrated and cied pocket was flushed with antibiotics prior to implant. Physician believes that the reported seroma is probably related to the cangaroo envelope device. Physician is aware of the off-label usage of the cangaroo envelope as a barrier. Device remains implanted. Attempts to obtain additional information from the physician regarding this seroma report have been unsuccessful up to time of this report. Should aziyo receive any additional information regarding this event, a supplemental 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 Key11354501
MDR Text Key232845306
Report Number3005619880-2021-00002
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
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 Received01/21/2021
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: 02/19/2021 Patient Sequence Number: 1
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