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

Model Number	CMCV-014-609
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Hematoma (1884); Rupture (2208)
Type of Reportable Event	Serious Injury
Event or Problem Description
Report from business partner regarding adverse event described as "patch blew out 5 weeks after a carotid endarterectomy." patient had been implanted with vascure for vascular repair (model # cmcv-014-609, lot #unknown).Event failure reported as device-related large hematoma requiring repair by carotid bypass.Date report received by partner 10oct2023, and forwarded to aziyo/elutia on 11oct2023 - actual date of event not known.No further information is available, a follow-up report will be updated if more information is received regarding this event.
Additional Manufacturer Narrative
No sample was returned for evaluation.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.It is noted that per the instructions for use provided with the finished vascure for vascular repair device, hematoma and patch dehiscence/ rupture (deterioration) are listed as potential complications associated with an endarterectomy procedure and device usage.The additional information provided by the surgeon implies that the patch dissolved and did not repair the defect."hematoma" was the original diagnosis, indicating that there was bleeding at the site of the patch.The source of the bleeding cannot be conclusively determined.However, the surgeon indicated that the patch was hydrated in heparinized saline prior to implantation (not indicated in the ifu).This could have had an impact on the integrity of the patch itself.It is also likely the patient was placed on anticoagulation therapy for the underlying condition that required the endarterectomy, making the development of a post-op hematoma more likely than a patient who was not on anticoagulants.

• Brand Name: VASCURE FOR VASCULAR REPAIR
• Common Device Name: 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 30076
• MDR Report Key: 18144317
• Report Number: 3005619880-2023-00004
• Device Sequence Number: 18044706
• Product Code: DXZ
• UDI-Device Identifier: 10859389005147
• UDI-Public: 10859389005147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: CMCV-014-609
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown