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U.S. Department of Health and Human Services

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

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AZIYO BIOLOGICS, INC. CORMATRIX CANGAROO ECM ENVELOPE MESH, SURGICAL Back to Search Results
Model Number CMCV-009-MED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 01/23/2017
Event Type  Injury  
Manufacturer Narrative
Manufacturing review of the device history record for the reported lot shows that all units were quality released on 8/22/2016 having met all internal qc acceptance requirements. 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. There were no non-conformances associated with the manufacturing lot during production, sterilization and final packaging. In lieu of a request for the oem supplier dhr review, it is noted that aziyo processes the non-sterile ecm materials by cutting, suturing, packaging, and sterilizing. In the ifu (p/n 20266-031314) under the section, potential complications, it states in part, "device-related complications are possible hematoma. " the cause for recurrent hematomas cannot be conclusively determined; however the site investigator states that the event's probable cause was therapeutic coumadin, anticoagulation with platelet dysfunction and bleeding diathesis.
 
Event Description
Original information received on 1/30/2017: ae#1 - it was reported that a cangaroo ecm envelope was used on a (b)(6) white male with risk factors of systemic anticoagulants, renal insufficiency and smoker. Implant procedure was on (b)(6) 2017 and a pm was placed. Ecm was soaked in gentamycin and iv antibiotic given pre-operatively. On (b)(6) 2017 subject was admitted to the hospital for thrombocytopenia (past medical history of this) with platelets at 111. He also was noted to have a hematoma at this time. It is currently unknown if the events are related to the cormatrix device or procedure. Additional information has been requested. On 2/1/2017 additional information received states that there were two recurrent events for hematoma's. Ae#1 on (b)(6) 2017 the patient was admitted for thrombocytopenia and was given a platelet infusion. The site investigator states that the event's probable cause was therapeutic coumadin and anticoagulation with platelet dysfunction. Ae#2 on (b)(6) 2017 the patient was hospitalized due to recurring hematoma and it was decided that the patient needed a pocket revision and exploration. The ecm pouch was removed and the event was concluded by investigator to be possibly related to procedure and not related to ecm device, but that the probable cause was bleeding diathesis. On 7/20/2018 following an audit/review of site clinical files, additional information was identified as follows: ae#1 - event resolved on (b)(6) 2017 and the description for the event as recorded on the case report form (crf) changed to "patient admitted on (b)(6) 2017 for bleeding with hematoma and history of thrombocytopenia. Given a platelet infusion and therapeutic anticoagulation. Platelet count
=
145. Also the site indicated that the event was "possibly related" to the device. Ae#2 - information recorded on the initial case report form was revised to reflect: event was "possibly related" to the device and probable cause of the event was "bleeding diathesis".
 
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Brand NameCORMATRIX CANGAROO ECM 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 Key7806686
MDR Text Key117915611
Report Number3005619880-2018-00008
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/25/2018
Device Model NumberCMCV-009-MED
Device Lot NumberM16H1209
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 Received07/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2016
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: 08/22/2018 Patient Sequence Number: 1
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