MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-04 for PROXICOR FOR CARDIAC TISSUE REPAIR CMCV-120-404 manufactured by Aziyo Biologics, Inc..
[177561445]
Manufacturing review of the device history record for the reported lot shows that all units were quality released on 11/27/2019 having met all internal qc acceptance requirements. There were no non-conformances associated with the manufacturing lot during production and final packaging. The oem supplier reviewed the sub-lots associated with the reported lot and confirmed that "all devices met specification. " the instructions for use provided with the proxicor for cardiac tissue repair product (art-20700b), under the section 'potential complications', states in part: "the following complications are possible. If any of these conditions occur, a medical professional should evaluate if the removal of the proxicor is required: patch dehiscence or rupture. " it can be noted that the reported saline soak time prior to use was 10 minutes. The ifu recommends soak time of 1-2 minutes. The exact cause of the reported event cannot be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[177561446]
On (b)(6) 2019 a newborn female patient underwent surgery for a diagnosis of aortic arch hypoplasia and ivc. Aziyo proxicor for cardiac tissue repair (ctr) was used. Once the patient was sutured, hemodynamic deterioration occured. Arterial line (umbilical artery cannulation) checked; malfunction is ruled out. An ecography checked the position of the ctr patch. Since the hemodynamic compromise was maintained, the patient was reconnected to extracorporeal circulation. Once again exposing the operative field, the doctor visualized that the ctr patch presents what he described as a "dissection" of the same. Ctr removed and replaced with a baxter peri-guard pericardium patch. Patient subsequently taken to neonatal icu where, after a couple of hours, patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005619880-2020-00001 |
| MDR Report Key | 9664341 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-12-24 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2019-11-27 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | PROXICOR FOR CARDIAC TISSUE REPAIR |
| Generic Name | PROXICOR FOR CARDIAC TISSUE REPAIR |
| Product Code | DXZ |
| Date Received | 2020-02-04 |
| Model Number | CMCV-120-404 |
| Lot Number | M19M1538 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Death | 2020-02-04 |