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

Model Number	CMCV-014-609
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an aziyo sales representative on (b)(6) 2020 that a 1cm x 10cm vascure for vascular repair (model #: cmcv-014-609, lot #: m20g1210) was used in a carotid endarterectomy procedure on a male patient on (b)(6) 2020.On (b)(6) 2020, the patient presented with a hematoma covering his right neck.The patient was transferred to baptist health, where the original implanting surgeon elected to re-open the site.Upon accessing the carotid artery, the surgeon reported that the integrity of the patch appeared to be compromised, reporting that the ecm patch appeared to have disintegrated.It was also noted that the implanting surgeon recalled the patch in question being difficult to penetrate while suturing during the original procedure.The vascure patch was explanted and replaced with bovine pericardium.Patient is doing well.
Additional Manufacturer Narrative
Manufacturing review of the vascure for vascular repair device history record shows that the referenced lot was released to distribution on 7/15/2020 having met all aziyo quality release requirements.There were no non-conformances identified during the manufacturing process.Review of the raw material device history record by the component lot manufacturer identified no manufactuirng issues associated with the specified lot that would lead to the reported material thickness or difficult needle penetration issue.Needle penetration of the ecm material can be influenced by many factors including a damaged needle tip, angle of approach taken during suturing etc.Evaluation of the lot sample from same batch/manufacturing lot returned from the user facility found that the device met the original part specification (dimensions/visual characteristics) for the sis-ecm material.Further, the returned lot sample was functionally evaluated prior to and following device hydration according to the instructions for use and the sample had no visual defects within the 1cm x 10cm piece of tissue potentially contributing to alleged thickness issues.Visual inspection as well as evaluation of tissue for potential delamination issues yielded no discrepant results.As the ecm material is a biologic made from decellularized porcine small intestinal submucosal layers and lyophilized, material thickness was assessed and found negligible (~0.002") material thickness variation prior to, and following hydration unlikely impacting needle penetration forces.While the exact cause of the reported event for hematoma, and subsequent identification of patch dehiscence/rupture cannot be conclusively determined, both hematoma and patch dehiscence are known potential complications associated with carotid endartarectomy procedures and both complications are provided in the vascure for vascular repair instructions for use (art-20708a) provided with each distributed device.No further details are available at this time, should aziyo receive any additional details related to this event, a supplemental report will be filed.

• 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: 11051758
• Report Number: 3005619880-2020-00107
• Device Sequence Number: 2665649
• Product Code: DXZ
• UDI-Device Identifier: 00859389005140
• UDI-Public: 00859389005140
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K111187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: 09/30/2021
• Device Model Number: CMCV-014-609
• Device Lot Number: M20G1210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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