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 Hematoma (1884)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

No sample was returned for evaluation.Manufacturing review of the cangaroo device history record could not be performed as the model/lot/serial numbers were not reported.It is also noted that per the instructions for use (ifu - art-20828a) provided with the finished cangaroo envelope device, 'hematoma' is listed as a potential complication associated with this procedure and device usage.The patient was on anticoagulants which would have increased the likelihood of post-operative hematoma formation.The ifu provided with the aziyo product indicates that the usage of certain glues in contact with the device can interrupt the remodeling process.However, the reference to the use of glue to seal the incision likely had no impact on the reported hematoma formation.The presence of the hematoma likely led to the wound dehiscence as there would have been pressure exerted on the incision, allowing for the failure of the glue.Therefore, the wound opening was not a separate adverse event related to the aziyo product itself but likely caused by the adverse event of the hematoma.

Event Description

Clindex report from site stated adverse event during (b)(6) study indicating that patient was implanted with a cangaroo envelope on (b)(6) 2021 (model # / lot # not reported) hydrated with saline and gentamicin and a st.Jude pacemaker (quadra allure mp 3562).Patient was given iv antibiotics (cefazolin) intra-op.No hemostatic agents were given intra-pocket during the implant.Pocket incision was closed with glue (type not specified).On (b)(6) 2021, patient presented at follow-up visit with a hematoma and procedure/visit notes state that there was a 1.5cm opening in the wound noted.Surgical site was repaired with 3 silk sutures and prophylactic oral antibiotics (keflex for 7 days) prescribed.Event resolved without sequelae.Hematoma event listed as "mild" and "probably-related" to procedure and "possibly" related to aziyo device.

• 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: 12811001
• MDR Text Key: 282357991
• Report Number: 3005619880-2021-00044
• 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: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/15/2021
• 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
• Treatment: QUADRA ALLURE MP 3562 (ST. JUDE)
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American