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

Model Number	CMCV-013-609
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Hematoma (1884); Failure of Implant (1924)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on (b)(6) 2022, showing that all units were quality released on (b)(6) 2022 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.A request for review from the oem supplier of the ecm was completed; however, no manufacturing related issues were identified potentially contributing to the reported issue.The exact cause of the reported delamination event cannot be conclusively determined.However, the ifu supplied with the device lists 'undesired tissue remodeling, including rapid degradation of vascure' as a known complication associated with the use of the vascure for vascular repair device and the surgical implant procedure.The exact cause of the hematoma event also cannot be conclusively determined.It is unknown if the hematoma arose from the delamination event.It could also have occurred due to the patient having her surgical site manipulated twice, the likelihood that she was anticoagulated, and her history of hypertension and diabetes.However, the ifu supplied with the device lists 'hematoma' as a known complication associated with the use of the vascure for vascular repair device and the surgical implant procedure.
Event or Problem Description
Aziyo sales rep reported that physician placed an aziyo vascure for vascular repair device (model cmcv-013-609, lot m21k1359) to repair a carotid artery.Physician reported "patch failed within the suture line".He stated that the patch appeared to "delaminate in the center of the patch".Date of implant reported as (b)(6) 2022.On (b)(6)2022, patient had a placement of a heparin-bond covered stent and (b)(6) 2022 had the drainage of a hematoma.The aziyo device remains in place.

• Brand Name: VASCURE FOR VASCULAR REPAIR
• Common Device Name: PATCH, PLEDGET-INTRACARDIAC
• 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: 14285962
• Report Number: 3005619880-2022-00013
• Device Sequence Number: 12314345
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2022

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: 12/31/2022
• Device Model Number: CMCV-013-609
• Device Lot Number: M21K1359
• 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: 04/12/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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 Age: 63 YR
• Patient Sex: Female