MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. VASCURE FOR VASCULAR REPAIR; PATCH, PLEDGET AND INTRACARDIAC, PETP

Model Number CMCV-014-609

Device Problem Peeled/Delaminated (1454)

Patient Problem Pseudoaneurysm (2605)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

No sample was returned for investigation.The hospital provided their evaluation from pathology lab which stated "diagnosis: right carotid pseudoaneurysm excision repair: arterial wall tissue with mixed inflammation and mural degenerative changes, consistent with stated origin.'" manufacturing review of the vascure for vascular repair device history record for the referenced lot number and respective device history record was conducted on 13may2021, showing that all units were quality released on 06/09/2020 having met all internal qc acceptance requirements for release.There were no non-conformances associated with the manufacturing lot during the final packaging.An additional request for lhr review was made to the oem supplier of the ecm and completed on 17may2021.This review concluded that all devices released for distribution met the final inspection specification requirements.It is noted that per the instructions for use (ifu - art-20708a) provided with the finished vascure for vascular repair device, (pseudo)aneurysm is listed as a potential complication associated with the procedure and device.No additional details are available for the reported event, should additional details be received a follow-up report will be filed.

Event Description

It was reported to an aziyo biologics' sales representative via email that surgeon used a aziyo vascure for vascular repair (model #cmcv-014-609, lot # m20f1174) for a de novo carotid endarterectomy on (b)(6) 2020.On routine post-op ultrasound, pseudoaneurysm was found in patch.On (b)(6) 2020, the patch was removed and replaced due to a pseudoaneurysm in the middle of the patch.The patient is doing well with the new patch.This issue was reported to aziyo biologics on 5/05/2021, on 5/11/2021 additional information received from hospital pathology stating diagnosis as right carotid pseudoaneurysm, excision repair: arterial wall tissue with mixed inflammation and mural degenerative changes consistent with stated origin.

• Brand Name: VASCURE FOR VASCULAR REPAIR
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• Manufacturer (Section G): AZIYO BIOLOGICS, 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: 11912522
• MDR Text Key: 253564450
• Report Number: 3005619880-2021-00017
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: CMCV-014-609
• Device Lot Number: M20F1174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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
• Patient Age: 83 YR