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

Model Number	CMCV-009-LRG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	05/23/2020
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 quality released to distribution on 01/29/2020 having met all internal qc acceptance requirements.All sterilization processing records and bioburden testing indicate a successful sterilization cycle and passing results of product lal and sterility samples allowing the subassembly lot to be released for further packaging and labeling having met all criteria for release.There were no non-conformances during manufacturing or sterilization potentially impacting the final acceptance of this manufacturing lot.In lieu of a request for the oem supplier dhr review, it is noted that aziyo processes the non-sterile envelope materials including cutting, suturing, packaging and sterilizing the product.It is noted that the reported events do not meet the criteria for a complaint, in that the event was physician induced through incision manipulation, however as the result of the event involved a pocket revision involving the cangaroo envelope, an adverse event report is still warranted.Although the reported event cannot be traced specifically to the cangaroo envelope, pocket revisions are a known complication to the surgical implant procedure of a cied.Should aziyo receive any additional details related to this event, a supplemental report will be filed.
Event or Problem Description
It was reported by aziyo biologics' business partner, boston scientific, that a cangaroo envelope (model #cmcv-009-lrg, lot #m20a1044) was used with a boston scientific cied (model # / serial # unknown) and implanted on (b)(6) 2020.On (b)(6) 2020, the physician was removing a scab from the incision line which resulted in an opening of the incision.Hence, the physician performed a pocket revision.The entire system remained in service including the aziyo cangaroo envelope.There were no additional patient effects reported.This issue was reported to aziyo biologics on 06/09/2020 by boston scientific, with additional details provided on 07/09/2020.

• 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: 10255874
• Report Number: 3005619880-2020-00038
• Device Sequence Number: 16914953
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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: 05/06/2022
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M20A1044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 07/09/2020
• 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