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U.S. Department of Health and Human Services

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

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AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE MESH, SURGICAL - FTM Back to Search Results
Model Number CMCV-009-XLG
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Sepsis (2067)
Event Date 11/19/2020
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 quality 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 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 also noted that per the instructions for use (ifu - art-20662) provided with the finished cangaroo envelope device, infection is listed as a potential complication associated with the procedure and device. Although the exact cause of the reported infection and resulting sepsis event cannot be conclusively determined, infection is a known complication associated with the use of a cangaroo envelope and a surgical implant procedure. 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-xlg; lot #m20a1016) was used with a boston scientific cied (model # / serial # unknown) and implanted on (b)(6) 2020. It was reported by bsc that on (b)(6) 2020 the cied device, leads, and cangaroo envelope were explanted due to pocket infection with sepsis. The device and leads will not be returned for analysis. Unknown if antibiotics were given. This issue was reported to aziyo biologics by boston scientific on (b)(6) 2020. Attempts to obtain additional information from the physician regarding sepsis determination have been unsuccessful up to time of this report. Should aziyo receive any additional information regarding this event, a supplemental report will be filed.
 
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Brand NameCANGAROO ENVELOPE
Type of DeviceMESH, 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 Key11098005
MDR Text Key230450808
Report Number3005619880-2020-00108
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial
Report Date 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/23/2022
Device Model NumberCMCV-009-XLG
Device Lot NumberM20A1016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/30/2020 Patient Sequence Number: 1
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