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

Model Number	CMCV-014-609
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the vascure for vascular repair device history record for the reported lot shows that all final packaged and labeled units were quality released to distribution on 04/29/2020 having met all internal aziyo qc acceptance requirements.Device manufacture and sterilization activities are performed by a contract manufacturer, request for review of associated batch and sterilization records indicate no nonconformances associated with the subassemblies utilized in this manufacturing lot.It is also noted that per the instructions for use (ifu - art-20708a) provided with the finished vascure for vascular repair device, hematoma, patch dehiscence/ rupture (deterioration), and infection are listed as a potential complications associated with an endartarectomy procedure and device usage.It is further noted that klebsiella bacteria (pneumonia, or oxytoca) are mostly spread through person-to-person contact.Less commonly, they are spread by contamination in the environment.As with other healthcare-associated infections, the bacteria can be spread in a health care setting via the contaminated hands of health care workers.Although the exact cause of the reported issue cannot be conclusively determined the reported hematoma or resulting dehiscence/ rupture (deterioration) are known complications associated with the use of a vascure for vascular repair and a surgical implant procedure.Should aziyo receive any additional details related to this event, a supplemental report will be filed.
Event or Problem Description
It was reported on 09/24/2020 by a aziyo sales representative that they spoke with physician this morning regarding an adverse event related to an implant of a aziyo vascure (model #: cmcv-014-609; lot #: m20d1145) performed on (b)(6) 2020 for a carotid endarterectomy on a relatively young and otherwise healthy patient.The patient returned this week with a hematoma and was reoperated on this morning.The patch was found to have disintegrated at the corner for no apparent reason.A sample was sent for to the hospital pathology lab for histology.Upon exposure during re-op, the physician observed that the vascure patch had dehisced in the center, with original sutures left intact anchoring the patch to the artery.Further information received from physician indicating that the hospital lab sample was found to have been infected with klebsiella.

• Brand Name: VASCURE FOR VASCULAR REPAIR
• Common Device Name: PATCH, PLEDGET & INTRACARDIAC - DXZ
• Manufacturer (Section D): AZIYO BIOLOGICS INC; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 10736414
• Report Number: 3005619880-2020-00075
• Device Sequence Number: 13921269
• Product Code: DXZ
• UDI-Device Identifier: 10859389005147
• UDI-Public: 10859389005147
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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 Expiration Date: 06/30/2021
• Device Model Number: CMCV-014-609
• Device Lot Number: M20D1145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention