MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-04 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175926P0 manufactured by Intervascular Sas.
[167825870]
(b)(4). The investigation is still ongoing. A follow-up report will be sent upon completion of the investigation. Device is not accessible for testing as it remained implanted in the patient.
Patient Sequence No: 1, Text Type: N, H10
[167825871]
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 | 1640201-2019-00077 |
| MDR Report Key | 9157413 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-04 |
| Date of Report | 2019-10-04 |
| Date of Event | 2019-08-31 |
| Date Mfgr Received | 2019-09-09 |
| Device Manufacturer Date | 2018-11-07 |
| Date Added to Maude | 2019-10-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | ZONE INDUSTRIELLE ATHELIA I |
| Manufacturer City | LA CIOTAT |
| Manufacturer Country | US |
| Manufacturer G1 | INTERVASCULAR SAS |
| Manufacturer Street | ZONE INDUSTRIELLE ATHELIA I |
| Manufacturer City | LA CIOTAT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR |
| Generic Name | GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE |
| Product Code | MAL |
| Date Received | 2019-10-04 |
| Model Number | M00202175926P0 |
| Catalog Number | M00202175926P0 |
| Lot Number | 18L07 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2019-10-04 |