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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 Twiddlers Syndrome (2114); Insufficient Information (4580)
Event Date 07/14/2020
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 01/27/2020 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. 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 #: m20a1045) was used with a boston scientific device (model # / serial # - unknown) and implanted on (b)(6) 2020. On (b)(6) 2020, the surgeon needed to reopen the pocket due to a lead tip becoming dislodged from the heart. A replacement ecm envelope was used as the previous envelope was damaged upon device removal. No migration within the pocket was noted and it was confirmed that the lead tip had dislodged from the heart. The root cause was likely patient induced from excessive arm movement.
 
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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
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 Key10477397
MDR Text Key205134657
Report Number3005619880-2020-00044
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,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/11/2022
Device Model NumberCMCV-009-XLG
Device Lot NumberM20A1045
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 Received08/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2020
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: 09/01/2020 Patient Sequence Number: 1
Treatment
BSC CIED (MODEL# / SERIAL# -UNKNOWN)
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