MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CORMATRIX ECM FOR VASCULAR REPAIR; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number CMCV-011-606

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pseudoaneurysm (2605)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

The cormatrix ecm for vascular repair product was returned to aziyo for histological analysis.The sample was shipped to a lab for histological analysis on 9/17/2018.The histological evaluation is currently pending and has not been received as of 10/8/2018.A review of the complaint log shows that this is the only complaint/event associated with this lot number.Manufacturing review of the device history record for the reported lot shows that all units were quality released on 5/5/2017 having met all internal qc acceptance requirements.There were no aziyo non-conformances associated with the manufacturing lot during production and final packaging.The ifu instructions for the vascular product that was provided with the product (part number 20438-032514) was reviewed.Under the section "potential complications", pseudoaneurysm is listed.The exact cause of the reported event cannot be conclusively determined; the site states that the patient was on cardiac drugs that could have caused or contributed to the event.It was stated that the patient having pre-existing conditions of: coronary heart disease, hypertension, and smoking could have contributed to the event as well.A follow-up report with supplemental information will be submitted following receipt of the histological analysis.

Event Description

It was reported that a cormatrix ecm for vascular repair (cmcv-011-606, lot #m17e1099) was implanted on (b)(6) 2017 for a right iliofemoral endarterectomy on a (b)(6) -year-old male.The device was explanted on (b)(6) 2018 due to right groin pseudoaneurysm and peripheral vascular disease with right leg claudication.

Manufacturer Narrative

Histological analysis on (b)(6) 2018 revealed that the sample had "marked intimal hyperplasia with chronic inflammation resembling a foreign body reaction to the multilaminate ecm device.".

• Brand Name: CORMATRIX ECM FOR VASCULAR REPAIR
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 7952938
• MDR Text Key: 123356195
• Report Number: 3005619880-2018-00010
• Device Sequence Number: 0
• Product Code: DXZ
• PMA/PMN Number: K140789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: CMCV-011-606
• Device Lot Number: M17E1099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 VESSEL FEN-EVAR W/PMEG ZFEN-P & ZFEN-D; PTA & STENT BILAT ILIAC ARTERIES W/VIABAHNS & PTA; PTA & STENT OF R EXT ILIAC W/10MM X 10CM VIABAHN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 96