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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-MED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/07/2020
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 04/17/2020 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. The reason for the explantation of the aziyo device is was related to a tuning issue with the implanted cied and device leads resulting in high pacing thresholds which would potentially decrease battery life. A replacement device and cangaroo envelope were implanted following removal. Device tuning issues are a recognized procedural complication associated with cied implantation, and not associated with usage of the cangaroo envelope. 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 #m20d1137) was used with a boston scientific device (model # / serial # unknown) and implanted on (b)(6) 2020. On (b)(6) 2020 the device and cangaroo pouch were explanted due to a lead revision procedure required due to high pacing thresholds. A new device and cangaroo envelope were implanted. This issue was reported to aziyo biologics by boston scientific on 10/22/2020 and further information received on 11/18/2020.
 
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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
4705144023
MDR Report Key10861895
MDR Text Key216963589
Report Number3005619880-2020-00095
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 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMCV-009-MED
Device Lot NumberM20D1137
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 Received10/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2020
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: 11/18/2020 Patient Sequence Number: 1
Treatment
BSC CIED (MODEL# / SERIAL# - UNKNOWN)
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