MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-22 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175928P0 manufactured by Intervascular Sas.
[117892025]
Device is not accessible for testing as it remained implanted in patient. A review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests. These tests include a 100 % visual inspection of the graft using fluorescent light to reveal the presence of any holes in the textile structure. Moreover, the review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications. The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number. A video of the surgery was provided by the user. The corporate medical officer carefully observed this video and commented that "the patient appears to be still on extracorporeal circulation therefore fully heparinized. At this stage of the operation any leakage will be more evident because of the level of heparinization. Moreover, this kind of procedures requires relatively long extracorporeal circulation adoption therefore the coagulation parameters will be more adversely impacted. The leakages appear to be minimal in clinical significance and likely to stop after the administration of protamine. The graft remained implanted and to our knowledge the patient did not have any adverse clinical consequence due to this event. " the investigation is still ongoing. A non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.
Patient Sequence No: 1, Text Type: N, H10
[117892026]
During surgery for aneurysmal disease, the graft has a serious hole bleeding problem. There was no transfusion during the surgery. Surgeon used drugs as novoseven and bioglue to stop the bleeding. The patient remained implanted and stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2018-00019 |
| MDR Report Key | 7805508 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-22 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-07-19 |
| Date Mfgr Received | 2018-09-10 |
| Device Manufacturer Date | 2018-04-11 |
| Date Added to Maude | 2018-08-22 |
| 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 | MRS. LAURE FRAYSSE |
| Manufacturer Street | Z.I. ATHELIA I |
| Manufacturer City | LA CIOTAT CEDEX, 13705 |
| Manufacturer Country | FR |
| Manufacturer Postal | 13705 |
| Manufacturer G1 | INTERVASCULAR SAS |
| Manufacturer Street | Z.I. ATHELIA I |
| Manufacturer City | LA CIOTAT CEDEX, 13705 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 13705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2018-08-22 |
| Model Number | M00202175928P0 |
| Catalog Number | M00202175928P0 |
| Lot Number | 18D11 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVASCULAR SAS |
| Manufacturer Address | Z.I. ATHELIA I LA CIOTAT CEDEX, 13705 FR 13705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-22 |