MAUDE Adverse Event Report: AZIYO BIOLOGICS INC. CORMATRIX ECM FOR CAROTID REPAIR; PATCH, PLEDGET AND INTRACARDIAC - DXZ

Model Number CMCV-072-606

Device Problem Off-Label Use (1494)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the cormatrix ecm for carotid repair device history record could not be completed as the lot/serial number was not provided.It is noted that the usage of the cormatrix ecm for carotid repair, now vascure for carotid repair for forming a tubular graft and usage for arteriovenous fistula is an unapproved, off-label usage.Should the device have been used per approved indications, the instructions for use (ifu - art-20702b) provided with the finished cormatrix ecm for carotid repair device lists stenosis and thrombosis as potential complications associated with the procedure and device.Futher, the same instructions for use state in warnings & precautions, and in the suggested instructions for implantation (step #6), reflect that the edges of the device must be sutured to viable native tissue and must not be sutured to homografts, synthetic or chemically cross-linked materials.The joining of three 10cm pieces of ecm tissue does not provide suturing of device ends to viable native tissue.Should aziyo receive any additional details related to this event, a supplemental report will be filed.

Event Description

As part of the post market surveillance process, this prospective pilot case study report published in the journal of vascular access 1-7.2019 titled "using cormatrix for partial and complete (re)construction of arteriovenous fistulas in haemodialysis patients: (re)construction of arteriovenous fistulas with cormatrix" was reviewed.This article provides the results of six (6) patients who underwent surgery between may 2016 and july 2018 for vascular access reconstruction due to thrombosis of unsalvageable arteriovenous fistulas, patients with high-flow arteriovenous fistulas and patients with microvasculature in which autologous arteriovenous fistulas did not mature.This report is focused on patient #2 (per publication table 1: patient demographics) where a (b)(6) yr.Old male with thrombosed radiocephalic arteriovenous fistula (avf) with ptfe graft on left upper arm.The surgeon utilized a tunneling device and a three (3) pieces of 2cm x 10cm cormatrix ecm for carotid repair (now aziyo biologics model #: cmcv-072-606; lot #: unknown) off-label to create an 30cm (6mm diameter) loop between brachial artery and basilicvein with additional outflow to cephalic vein following excision of ptfe graft.At 5 months post-op, stenosis of the cormatrix venous anastomosis and avf thrombosis resulting in a percutaneous tea + pta.At 6 months post-op, stenosis of the cormatrix and at 10 months stenosis recurred at venous anastomosis and avf thrombosis resulting in a percutaneous tea + pta.At 17 months post-op, stenosis of cormatrix anastomosis with basilic vein treated with pta and insertion of venous stent.At 19 months avf thrombosis due to hypotension treated with percutaneous tea, and placement of additional venous stent.Finally at 21 months avf thrombosis because of relative in-stent stenosis, relative cormatrix stenosis at punction area and hypotension treated with percutaneous tea, pta of entire avf and deb of in-stent stenosis.Performed.Graft remained implanted through article follow-up period of 24 months.Attempts to contact corresponding author have been unsuccessful for any additional information.Should any additional information be received a follow-up report will be filed.

• Brand Name: CORMATRIX ECM FOR CAROTID REPAIR
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC - DXZ
• 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; 4705144023
• MDR Report Key: 10744177
• MDR Text Key: 213420179
• Report Number: 3005619880-2020-00056
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00859389005089
• UDI-Public: 00859389005089
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K111187
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMCV-072-606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR