MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-08 for VASCURE FOR VASCULAR REPAIR CMCV-014-609 manufactured by Aziyo Biologics, Inc..
[144484135]
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.
Patient Sequence No: 1, Text Type: N, H10
[144484136]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005619880-2019-00005 |
| MDR Report Key | 8593042 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-08 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2019-01-29 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANDREW GREEN |
| Manufacturer Street | 1100 OLD ELLIS ROAD STE 1200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer G1 | AZIYO BIOLOGICS, INC. |
| Manufacturer Street | 1100 OLD ELLIS ROAD STE 1200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30076 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASCURE FOR VASCULAR REPAIR |
| Generic Name | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Product Code | DXZ |
| Date Received | 2019-05-08 |
| Returned To Mfg | 2019-04-22 |
| Model Number | CMCV-014-609 |
| Lot Number | M19A1044 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AZIYO BIOLOGICS, INC. |
| Manufacturer Address | 1100 OLD ELLIS ROAD STE 1200 ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-08 |