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

Model Number	CMCV-009-LRG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on 18-oct-2021, showing that all units were quality released on 18-aug-2021 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot m21e1186 (prt-20679-03) was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 18-jun-2021 having met all quality requirements including product sterility testing following eo sterilization, as well as internal bioburden and product pyrogen (lal) testing requirements.In lieu of a request for the oem supplier for a dhr review of the ecm material lots, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing.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.
Event or Problem Description
Email from clinical research manager regarding a patient who had the removal of complete cardiovascular implantable electronic device (cied) system, including the aziyo cangaroo device on (b)(4) 2021.It was removed due to a left-sided pocket hematoma and a recent history of infection in previous right-sided pocket, without indication of infection of current site.On (b)(6) 2021, he went to the emergency department due to left pocket draining sanguineous drainage and slightly dehisced opening.He was placed on vancomycin/cefepime iv.Drainage changed from sanguineous to serous, no purulence.Patient was afebrile throughout hospital stay with one exception in emergency department of 100.5 degrees fahrenheit.On (b)(6) 2021, device was explanted.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: 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: 12770641
• Report Number: 3005619880-2021-00042
• Device Sequence Number: 14288595
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2023
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M21H1308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PACER CRT-P MRI MULTI-POINT RF-QUADRA ALLURE 3562
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 93 KG