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

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.

• 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: 11354501
• MDR Text Key: 232845306
• Report Number: 3005619880-2021-00002
• 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: company representative,health
• Reporter Occupation: Physician
• 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 Received: 02/19/2021
• 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: 01/21/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Other