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 Unspecified Infection (1930); Skin Erosion (2075)

Event Type  Injury  

Event Description

Email received from aziyo sales representative reporting that patient who underwent placement of a de novo icd (implantable cardioverter-defibrillator) with cangaroo envelope (model and lot unknown) developed a skin perforation with sanguineous drainage over the implant one month post-operatively (not at site of incision).Patient was given oral antibiotics which initially resolved the issue.Another skin perforation formed in a different location over the implant site and was again treated with oral antibiotics which appeared to resolve the issue.When a third perforation developed, the patient was hospitalized and given iv antibiotics which resolved the issue.There have been no further issues.

Manufacturer Narrative

No information was received providing the model or the lot number involved with this procedure.No product was returned to aziyo biologics for investigation.There were few details provided with this complaint and no dates were reported for any of these events.Since the use of antibiotics appeared to resolve the reported symptoms, it can be deduced that the source of the skin perforations was a pocket infection or cellulitis at the site of the implant, but not the actual incision.It is not possible to determine if the aziyo product was related to this event or if this was procedure-related, caused by trauma to the site, or due to an underlying patient condition.Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication associated with the use of a cangaroo envelope device and a surgical implant procedure (instructions for use - (b)(4)).Should aziyo receive any additional details related to this event, a supplemental report will be filed.

Manufacturer Narrative

No information was received providing the model or the lot number involved with this procedure.No product was returned to aziyo biologics for investigation.There were few details provided with this complaint and no dates were reported for any of these events.Since the use of antibiotics appeared to resolve the reported symptoms, it can be deduced that the source of the skin perforations was a pocket infection or cellulitis at the site of the implant, but not the actual incision.It is not possible to determine if the aziyo product was related to this event or if this was procedure-related, caused by trauma to the site, or due to an underlying patient condition.Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication associated with the use of a cangaroo envelope device and a surgical implant procedure (instructions for use - (b)(4)).Should aziyo receive any additional details related to this event, a supplemental report will be filed.

Event Description

Email received from aziyo sales representative reporting that patient who underwent placement of a de novo icd (implantable cardioverter-defibrillator) with cangaroo envelope (model and lot unknown) developed a skin perforation with sanguineous drainage over the implant one month post-operatively (not at site of incision).Patient was given oral antibiotics which initially resolved the issue.Another skin perforation formed in a different location over the implant site and was again treated with oral antibiotics which appeared to resolve the issue.When a third perforation developed, the patient was hospitalized and given iv antibiotics which resolved the issue.There have been no further issues.

• 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: 13523560
• MDR Text Key: 285543368
• Report Number: 3005619880-2022-00007
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• 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: 01/21/2022
• 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; Hospitalization
• Patient Sex: Male