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

Model Number CMCV-009-XLG

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

Patient Problem Unspecified Infection (1930)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cangaroo envelope device history record for the reported lot shows that all packaged and labeled units were released to distribution on (b)(6) 2020 having met all internal qc acceptance requirements.All sterilization processing records and bioburden testing indicate a successful sterilization cycle, and passing results for product lal and sterility samples allowed this subassembly lot to be released for further packaging and labeling.One non-conformance was associated with this lot, however it was issued to allow implementation of new 510(k) issuance for shelf life.This non-conformance had no impact on the sterility or lal results or the final acceptance criteria for this manufacturing lot.In lieu of a request for oem supplier dhr review for ecm lot, it is noted that aziyo processes the non-sterile envelope materials including cutting, suturing, packaging, and sterilizing the product.The returned sample was not capable of being evaluated for the reported event (not in envelope form etc.) and it would have provided no additional information to this investigation.No product defect was noted (e.G.Package breach, damage etc.), and infection is a known complication of the surgical procedure and implantation of a cied device with cangaroo.It is noted that per the instructions for use (art-20662) provided with the finished cangaroo envelope, that infection is listed as a potential complication associated with the procedure and device.Although the exact cause of the reported infection cannot be conclusively determined at this time, should any additional details be received by aziyo relating to this event, a supplemental report will be filed.

Event Description

It was reported by aziyo sales representative on (b)(6) 2020 that a physician reported an infection following implant of a biv device using a cangaroo envelope (model # cmcv-009-xlg, lot# m20a1025) on (b)(6) 2020.Physician reported gram negative growing from pocket and lead tip.Physician stated that "most likely not innoculation at implant site since those are usually gram positive.Most likely innoculated at home water is notorious for giving pseudomonas infection a gram negative." biv device and cangaroo envelope were explanted on (b)(6) 2020.

• Brand Name: CANGAROO ENVELOPE
• Type of Device: MESH, SURGICAL, FTM
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell, ga
• Manufacturer (Section G): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell, ga
• Manufacturer Contact: michael hennick ; 1100 old ellis road; ste 1200; roswell, ga ; 5144023
• MDR Report Key: 10261797
• MDR Text Key: 198553762
• Report Number: 3005619880-2020-00039
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 00859389005072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2022
• Device Model Number: CMCV-009-XLG
• Device Lot Number: M20A1025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2020
• 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