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

Model Number	CMCV-014-609
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the aziyo biologics device/lot history record for the reported lot shows that all units were quality released on 1/29/19 having met all internal qc acceptance requirements and met criteria for manufacturing release.There were no non-conformances associated with the lot.Oem supplier reviewed the sub-lots associated with the reported lot and it was stated that, "review confirms that all devices met specifications." a review of the complaint log shows that this is the only complaint associated with this lot number.Instructions for use (art-20708a) under the section warnings and precautions it states, "if delamination is observed, do not use vascure.Suggested instructions for using vascure for vascular repair: 5.If required, vascure can be cut to the appropriate size, using aseptic technique, in order to adequately cover the tissue deficiency/defect or treatment area.If delamination is observed, do not implant vascure." samples were returned to aziyo for investigation.The first sample reviewed was approximately 4.7cm in length, by approximately 1cm wide.The sample was observed to have peeled back approximately 1cm in length and 0.5cm high (or up the width of the sample).The second sample was reviewed and was observed to be 5cm in length, by approximately 1cm wide with a portion of separation/delamination approximately 1.7cm down the entire width of the device.A suture was observed to be attached to one of the ends.It can be noted that it appears that the whole portion of the original piece of vascure (1cm by 10cm) was returned in 2 sample portions as detailed above.No other remarkable findings were observed.
Event or Problem Description
It was reported that a vascure for vascular repair (model cmcv-014-609, lot m19a1044) was implanted for a carotid endarterectomy (cea) procedure on (b)(6) 2019 in a (b)(6) male patient.The device was soaked for one minute in saline.The device was sutured to carotid artery with a 7-0 prolene suture.No adhesive agents were used.After implanting the product along the carotid artery, surgeon says it did not look normal and was concerned that product separation had occurred.The product was explanted ((b)(6) 2019) after the surgeon was able to confirm on ultrasound that separation had occurred.A different product was then used for the procedure.The site states that the event is not related to the procedure and not related to the device and no patient comorbidities.No concerns with patient outcome.

• Brand Name: VASCURE FOR VASCULAR REPAIR
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 8593042
• Report Number: 3005619880-2019-00005
• Device Sequence Number: 2010781
• Product Code: DXZ
• UDI-Device Identifier: 00859389005140
• UDI-Public: 00859389005140
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2019

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: 03/31/2020
• Device Model Number: CMCV-014-609
• Device Lot Number: M19A1044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/08/2019
• 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
• Patient Age: 63 YR