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

Model Number CMCV-009-LRG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on 8sep2021, showing that all units were quality released on 3jun2021 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot m21c1120 (prt-20679-03) was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 29apr2021 having met all quality requirements including product sterility testing following eo sterilization, as well as internal bioburden and product pyrogen (lal) testing requirements.Expiration date was 29sep2023.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, infection is listed as a potential complication associated with this procedure and device usage.

Event Description

On (b)(6) 2021 patient had icd implanted along with aziyo envelope cmcv-009-lrg, lot # m21e1181.On (b)(6) 2021 patient returned to facility with superior margins dehiscence of icd pocket noted and explant performed.Patient was treated with multiple iv antibiotics including cefazolin, ceftriaxone, vancomycin and nafcillin for mssa infection.According to the cath lab, the aziyo device was removed because the icd system was removed.The aziyo device was not believed to be the primary product requiring explantation of the system.

• 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: 12541836
• MDR Text Key: 276838173
• Report Number: 3005619880-2021-00031
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• 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: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2021

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
• Device Expiration Date: 09/29/2023
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M21E1181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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
• Patient Age: 76 YR
• Patient Weight: 143