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U.S. Department of Health and Human Services

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

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AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE MESH, SURGICAL Back to Search Results
Model Number CMCV-009-MED
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problem Reaction (2414)
Event Date 06/18/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturing review of the aziyo biologics device/lot history record for the reported lot shows that all units were quality released to finished goods on 4/11/2019 having met all internal qc acceptance requirements and met criteria for manufacturing release. There were no non-conformances associated with the manufacturing lot. All sterilization records, and bioburden testing indicate successful sterilization process, and passing lal and product sterility results allowed the lot to be released having met all criteria for manufacturing release. The exact relationship to the device cannot be conclusively determined. It can be noted that culture results were negative. The final assessment from the ep team is that the pocket was not infected. However, focus was placed on the purulent exudate and they assume the patient had some type of non-infectious reaction to the pouch utilized during the system upgrade on (b)(6) 2019. Although the exact cause of the reported event cannot be conclusively determined, allergic reaction is a known potential complication with the cangaroo envelope. Instructions for use with the cangaroo envelope state (art 20662b) under the section potential complications: allergic reaction to ecm.
 
Event Description
A male patient (age unknown) underwent an upgrade to a biv pacemaker with cangaroo envelope on (b)(6) 2019. The lv lead dislodged and lead revision was performed on (b)(6) 2019. The incision was opened and excessive fluid was noted draining from the pocket, which appeared to be a mixture of blood and a pus-like substance. Cultures were taken of this fluid. Once the fluid was cleared from the pocket, cultures were obtained on a portion of the pouch. Total system extraction (to include biv pacemaker and cangaroo envelope) was on (b)(6) 2019. The patient was re-implanted with a biv icd on (b)(6) 2019 on the right side of the chest (without cangaroo). Nasal screen on (b)(6) 2019 confirmed chronic (b)(6). All lab results/cultures resulted as negative. Patient discharged from hospital on (b)(6) 2019 with doxycycline 14-day treatment (for (b)(6)). Final assessment from the ep team is that the pocket was not infected. However, focus was placed on the purulent exudate and they assume the patient had some type of non-infectious reaction to the pouch utilized during the system upgrade on (b)(6) 2019.
 
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Brand NameCANGAROO ENVELOPE
Type of DeviceMESH, SURGICAL
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
andrew green
1100 old ellis road
ste 1200
roswell, GA 30076
MDR Report Key8841103
MDR Text Key152633455
Report Number3005619880-2019-00007
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/21/2021
Device Model NumberCMCV-009-MED
Device Lot NumberM19D1147561
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 Received07/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2019
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: 07/30/2019 Patient Sequence Number: 1
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