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

Model Number CMCV-009-XLG

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

Patient Problem Sepsis (2067)

Event Date 08/06/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, aziyo was notified by business partner boston scientific that a patient with a pulse generator implanted on (b)(6) 2021 and aziyo biologics cangaroo envelope (model cmcv-009-xlg, lot number m21d1130) presented with bacteremia.The aziyo device was explanted as part of the removal of the entire cardiovascular implantable electronic device (cied) system on (b)(6) 2021.The patient received iv antibiotics before and after the explant and the pocket was flushed with vancomycin prior to being sutured closed.Patient was reportedly discharged home with a wound vac and is currently doing well.The physician stated that he did not believe the aziyo product was related to, or responsible for, the infection.

Manufacturer Narrative

No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on (b)(6) 2021, showing that all units were quality released on (b)(6) 2021 having met all internal qc acceptance requirements.There was one nonconformance associated with the manufacturing lot during the final packaging which was addressed through a nonconforming materials report.It was resolved and was unrelated to the reported adverse event.Sterile subassembly lot m20m1337 (prt-20679-09) was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on (b)(6) 2020 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 nonsterile envelope materials by cutting, suturing, packaging, and sterilizing.It is also noted that per the instructions for use (ifu - art-20662c) provided with the finished cangaroo envelope device, "infection" is listed as a potential complication associated with this procedure and device usage.

• Brand Name: CANGAROO
• Type of Device: FTM. SURGICAL MESH
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 12631298
• MDR Text Key: 281005823
• Report Number: 3005619880-2021-00034
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 00859389005072
• Combination Product (y/n): N
• PMA/PMN Number: K201313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2023
• Device Model Number: CMCV-009-XLG
• Device Lot Number: M21D1130
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention