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 Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930)

Event Date 12/03/2021

Event Type  Injury  

Event Description

Clinical research manager of cangaroo study reported patient adverse event as follows: on (b)(6) 2021, patient received de novo implant of a biventricular pacemaker automatic implantable cardioverter defibrillator (biv aicd) with cangaroo envelope (model cmcv-009-lrg, lot number m21e1177636).On follow-up visit (b)(6) 2022, patient had signs of infection at implant site and was admitted to the hospital.Device explanted on (b)(6) 2022 and patient started on cephalexin.Physician reported that patient had a wound dehiscence which resulted in pocket infection.Physician reported that event was "probably related" to the implant procedure.Patient is male, (b)(6).

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) 2022, showing that all units were quality released on (b)(6)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 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 (b)(6) 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, "infection" is listed as a potential complication associated with this procedure and device usage.Although the exact cause of the reported issues cannot be conclusively determined, the root cause of the wound dehiscence, and resulting infection, is likely procedure related and could occur regardless of the use of the aziyo device.The aziyo device was sterilized with ethylene oxide gas and was supplied to the end user as a sterile device.The wound dehiscence is possibly related to the surgical technique of the surgeon--either in pocket sizing to accommodate all parts of the implant or in surgical closure of the implant site.It is also possibly related to the post-op care of the implant site provided by the patient.The presence of a dehiscence in the suture line would make the possibility of pocket infection extremely likely, as there is the creation of a communication from outside the patient into the wound pocket.Wound dehiscence and post-operative infection are both known potential complications of any surgical procedure.Should aziyo receive any additional details related to this event, a supplemental report will be filed.

Event Description

After initial filing of this mdr, it was reported that the patient developed a small hematoma on (b)(6) 2021, prior to the previously reported dehiscence/infection.It was described as clean, dry, and intact, likely the result of the surgical procedure, and unrelated to the implant of the aziyo device.No treatment was prescribed.

• 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: 13443917
• MDR Text Key: 288817785
• Report Number: 3005619880-2022-00003
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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: M21E1177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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): Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male