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

Model Number CMCV-009-LRG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the device history record for the reported lot shows that all units were quality released on 7/14/2017 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.It can be noted that per the instructions for use [ifu] (art-20524b provided with device) for the cangaroo ecm envelope currently lists hematoma as potential complications associated with the procedure and device.It can also be noted that under the section warnings and precautions it states "do not use the cormatrix cangaroo with fibrin glue or glue containing glutaraldehyde or other cross-linking agents." it can be noted that the event was stated to have used an arista product in conjunction with the ecm.Although the exact ifu is unknown, it can be referenced that arista ah ifu pk3798864 155r - states under section action: "enhance natural hemostasis by concentrating blood solids such as platelets, red blood cells, and blood proteins on the particle surfaces to form a gelled matrix.The concentration of clotting factors and platelets in the gel serves to enhance normal clotting reactions and creates stable hemostatic plugs." other adverse reactions include: cutaneous bleed, seroma, and hematoma.Also, it was found that the mechanism of action for the arista ah product is through microporous particles synthesized by cross-linking purified plant starch through a proprietary process (arista, 2006).Although the exact cause of the reported event cannot be conclusively determined, hematoma is a known complication with the cangaroo ecm.It can also be noted that the cangaroo ecm should not be used with any other cross-linking agents.Reference arista ah absorbable hemostatic particles.(2006, september 15).Retrieved april 3, 2018, from https://www.Accessdata.Fda.Gov/cdrh_docs/pdf5/p050038c.Pdf.

Event Description

It was discovered during a generator change out on (b)(6) 2018 swelling at the pocket, redness, and a hematoma was observed.Implant date was (b)(6) 2018.A hematoma was evacuated from the pocket and from that rapid cultures were negative and 48 hour culture from same fluid also negative.The hydration solution and time is unknown, but has been requested (only stated "no vancomycin" used).It was stated that arista, the hemostatic agent, was used in the pocket.No product was explanted.It was not noted if the event is related to the device or the procedure.

• Brand Name: CORMATRIX CANGAROO ECM ENVELOPE
• Type of Device: MESH, 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 Key: 7396767
• MDR Text Key: 104357030
• Report Number: 3005619880-2018-00003
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/17/2020
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M17E1115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention