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

Model Number CMCV-009-MED

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

Patient Problem Unspecified Infection (1930)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cangaroo envelope device history record for the reported lot reflects that all packaged and labeled units were quality released to distribution on 2/21/2020 having met all internal qc acceptance requirements.All sterilization processing records and bioburden testing results indicate a successful sterilization cycle, and passing results of lal and sterility bis allowed the subassembly to be released for further packaging and labeling activities.There were no non-conformances during manufacturing or sterilization potentially impacting 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 also noted that per the instructions for use (art-20662) provided with the packaged cangaroo envelope device, that infection is listed as a potential complication associated with the surgical procedure and usage of the cangaroo envelope.Although an exact cause of the reported infection cannot be conclusively determined, infection is a known complication associated with the surgical implantation of cieds and cangaroo envelope devices.Should aziyo receive any additional details related to this event, a supplemental report will be filed.

Event Description

It was reported by aziyo biologics' business partner boston scientific, that a cangaroo envelope (model cmcv-009-med lot# m20b1078) was used with a boston scientific device (model #/serial # unknown) and implanted on (b)(6) 2020.Patient developed an infection and on (b)(6) 2020 the entire system was explanted.The issue was reported to aziyo biologics 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 30076
• Manufacturer (Section G): AZIYO BIOLOGICS INC.; 1100 old ellis road; ste 1200; roswell 30076
• Manufacturer Contact: michael hennick ; 1100 old ellis road; ste 1200; roswell 30076 ; 4705144023
• MDR Report Key: 10554903
• MDR Text Key: 207732514
• Report Number: 3005619880-2020-00046
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• 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: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: CMCV-009-MED
• Device Lot Number: M20B1078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• 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