MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-25 for CORMATRIX ECM FOR VASCULAR REPAIR CMCV-014-609 manufactured by Aziyo Biologics, Inc..
[143117348]
A review of the complaint log shows that this is the only complaint associated with this lot number. Manufacturing review of the device history record for the reported lot shows that all units were quality released on 6/19/18 having met all internal qc acceptance requirements. There were no non-conformance's associated with the manufacturing lot during production and final packaging. Oem supplier reviewed the sub-lots associated with the reported lot and provided specific disposition details of non-conformance's. It was stated that, "based upon the review results, the non-conformance had no impact on the reported issue". The ifu instructions for the vascular product that was provided with the product (part number art-20713a) was reviewed and based on the information provided by the site, the ecm patch was prepared according to instructions for use. Under the section warnings and precautions, it states: "device is not recommended to be used with platelet gel. " pseudoaneurysm /aneurysm is listed as a potential complication. Additional information will be submitted once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[143117349]
It was reported that a vascular ecm (fp-20437-09, cmcv-014-609, 1cm x 10cm) was implanted for a carotid endarterectomy (cea) on (b)(6) 2018 in a male patient. The device was soaked for 30 seconds in saline. Standard procedure guidelines were followed. The ecm was sutured to patient tissue with a prolene suture. No adhesive agents were used; may have used thrombin. Symptoms occurred around 3-month checkup. Noticeable bulge at wound site. Ultrasound confirmed carotid aneurysm. Pictures during excision on (b)(6) 2019 show large, ballooned aneurysm in the patch. The ecm patch aneurysm was completely excised and replaced with an autologous vein patch. The site states that the event is possibly related to the procedure and probably related to the device. Patient is reported as doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005619880-2019-00004 |
| MDR Report Key | 8551247 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 2018-06-19 |
| Date Added to Maude | 2019-04-25 |
| 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 | CORMATRIX ECM FOR VASCULAR REPAIR |
| Generic Name | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Product Code | DXZ |
| Date Received | 2019-04-25 |
| Returned To Mfg | 2019-04-16 |
| Model Number | CMCV-014-609 |
| Lot Number | M18F1152 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-04-25 |