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

Model Number	CMCV-009-XLG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: MESH, SURGICAL, FTM
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell, ga
• MDR Report Key: 10261797
• Report Number: 3005619880-2020-00039
• Device Sequence Number: 3083803
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 00859389005072
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2020

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention