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

Model Number CMCV-014-609

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Rupture (2208)

Event Type  Injury  

Event Description

Email from business partner with an adverse event report filed by their sales representative.Incident report, dated on (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 (patient 1 [this report]), mdr 3005619880-2023-00006 (patient 2), and mdr 3005619880-2023-00007 (patients 3 - 6).This report is associated with patient #1 who was reported to have a "blowout" with a hole in the patch.This patient also reportedly developed an infection.The event was resolved by "clear[ing] the infection and go[ing] back in to stop the bleeding from the blowout" in a follow-up procedure.No additional information was provided despite repeated inquiries.Should any additional information of significance be received, a follow-up report will be filed.

Manufacturer Narrative

Manufacturing review of the vascure for vascular repair device history record for the reported event could not be completed, as the lot/serial number was not provided.Without additional information regarding this event, it is difficult to know if the description of the patch "blowout" is a failure of the patch itself or if the patch was displaced by the infection that developed post-operatively.It can be deduced that the patch site was noted to have displayed characteristics that required intervention, such as swelling.There is no mention of symptoms related to infection or further treatment for infection.Infections for this complaint (encompassing six patients) were reported to have developed between 2-6 weeks post-operative and patient 1 was not identified specifically nor was the treatment specified other than to report the infection was cleared out and bleeding arrested.There was no mention of the patch being replaced, repaired or other treatment to mitigate.The root cause of the infection was likely procedure-related and could occur regardless of the use of the device.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(s) are known potential complications of any surgical procedure.It is noted that per the instructions for use provided with the finished vascure for vascular repair device, infection and patch dehiscence/ rupture (deterioration) are listed as potential complications associated with an endarterectomy procedure and device usage.Should elutia receive any additional details related to these events, a supplemental report will be filed.

• 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: 18145216
• MDR Text Key: 328225228
• Report Number: 3005619880-2023-00005
• 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