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 Unspecified Infection (1930)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cangaroo envelope device history record could not be completed as the lot/serial number for this event is not known.It is also noted that per the instructions for use (ifu - art-20662) provided with the finished cangaroo envelope device,infection is listed as a potential complication associated with the procedure and device.Although the exact cause of the reported infection cannot be conclusively determined, infection 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

On 09/18/2020, it was reported by an aziyo sales representative that she had been informed of an infection involving cangaroo envelope (model #: unknown, lot #: unknown) at fort sanders regional hospital.Additional information was received on 10/09/2020 stating that patient returned for follow-up at 6 months post implant with an infection.Initial implant performed utilizing cangaroo envelope hydrated in vancomycin and gentamicin prior to implant (date not reported).Patient was referred to a larger hospital for extraction of the cied device and leads.It was also stated the event was not related to the aziyo device and probably related to the procedure as initial implant procedure lasted approximately 4 hours.Patient was healing and in stable condition.

• 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 ; 4705144023
• MDR Report Key: 10680528
• MDR Text Key: 211492360
• Report Number: 3005619880-2020-00090
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• 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: 09/17/2020
• 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