MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-18 for M00202175926P0 manufactured by Intervascular Sas.
[163189945]
(b)(6). Follow-up report will be submitted once new information is available.
Patient Sequence No: 1, Text Type: N, H10
[163189946]
The doctor did the operation on (b)(6) 2019. During the operation, they used one hemashield 4b graft and found the connection between the graft body and these three branches was bleeding a lot. And then they used the autologous pericardium to mend the bleeding site. It took around 15 hours to do this operation because of the bleeding issue and therefore they delayed sternal closure for the edema.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2019-01168 |
| MDR Report Key | 9211428 |
| Date Received | 2019-10-18 |
| Date of Event | 2019-08-31 |
| Date Facility Aware | 2019-09-30 |
| Report Date | 2019-10-18 |
| Date Reported to FDA | 2019-10-18 |
| Date Reported to Mfgr | 2019-10-18 |
| Date Added to Maude | 2019-10-18 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE |
| Product Code | MAL |
| Date Received | 2019-10-18 |
| Catalog Number | M00202175926P0 |
| Lot Number | 18L07 |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVASCULAR SAS |
| Manufacturer Address | ZONE INDUSTRIELLE ATHELIA I LA CIOTAT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-18 |