MAUDE Adverse Event Report: ELUTIA INC VASCURE FOR VASCULAR REPAIR; PATCH, PLEDGET-INTRACARDIAC-DXZ

Model Number CMCV-014-609

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the vascure for vascular repair device history record for the reported events could not be completed, as the lot/serial numbers were not provided.Infections for this complaint were reported to have developed between 2-6 weeks post-operative.The description from the rep's follow-up conversation with the physician implies that the patients all developed symptoms of a systemic infection, likely exhibiting fevers, and were placed on antibiotics.The reference to the infection not being at the site of the patch leads to the conclusion that there was no evidence of localized infection at the implant site.Had the physician believed the patch to be the source of the infection, it is likely he would have removed the patch; there was no such report in any of the six infections reported.The root cause of the infection is possibly due to a nosocomial infection and the device was not a direct contributor.The device was sterilized with ethylene oxide gas and was supplied to the end user as a sterile device.Post-operative infection are known potential complications of any surgical procedure.Without further information, it is assumed that the antibiotics mitigated the infection, as there is no report of further need for treatment.It is noted that per the instructions for use provided with the finished vascure for vascular repair device, infection is listed as a potential complication associated with an endarterectomy procedure and device usage.Should aziyo receive any additional details related to this event, a supplemental report will be filed.See attached excel spreadsheet for summary of four patients.

Event Description

Email from business partner with an adverse event report filed by their sales representative.Incident report, dated (b)(6) 2023, lists six (6) occurrences of infection of femoral endarterectomies over the past 9 months following repair using the vascure for vascular repair device (model #: unknown, lot #: unknown) and no specified implant date(s).The report from the sales representative states "they don't know if it was due to the patch; they typically would see 1-2 infections over a year." all patients were reported as having "no infections present at the time of initial surgery".Patients reported to have developed the infections between 2-6 weeks post-operatively.All patients reported now as doing well; no deaths reported.The reported 6 events will be filed in 3 different adverse event reports specific to the patient and health event codes associated with each event - specifically mdr 3005619880-2023-00005, (patient 1), mdr 3005619880-2023-00006 (patient 2), and mdr 3005619880-2023-00007 (patients 3 - 6 [this report]).This report is associated with patients #3 - #6 covering the four patients with reported post-op infections.Rep reported that "the surgeon told me that there were four 'primary infections' that were not 'superficial' in his words.He said for these four infections that they were not at the site where the patch was implanted." "they were put on antibiotics to clear the infection.".

• Brand Name: VASCURE FOR VASCULAR REPAIR
• Type of Device: PATCH, PLEDGET-INTRACARDIAC-DXZ
• Manufacturer (Section D): ELUTIA INC; 1100 old ellis road; ste. 1200; roswell GA 30076
• Manufacturer (Section G): ELUTIA INC; 1100 old ellis road; ste. 1200; roswell GA 30076
• Manufacturer Contact: michael hennick ; 1100 old ellis road; ste 1200; roswell, GA 27215
• MDR Report Key: 18145224
• MDR Text Key: 328223932
• Report Number: 3005619880-2023-00007
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 10859389005147
• UDI-Public: 10859389005147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMCV-014-609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2023
• 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