MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-08 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175824P0 manufactured by Intervascular Sas.
[135555621]
Device is not accessible for testing as it remained implanted in the 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 a backlit table to reveal the presence of any holes in the textile structure. The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number. The investigation is still ongoing. A follow-up report will be sent upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[135555622]
The event occurred during an on-pump surgery without intra-aortic balloon (iab) use. After completing the anastomosis of the graft to the aorta, a hole was identified by the appearance of a blood leak at the junction of the single branch of the graft. It was first mentioned that the surgeon sutured the hole to complete the operation. It was then stated that bleeding was stopped by the application of pressure for about 5 minutes. The graft remained implanted and no remaining fragment is available for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2019-00007 |
| MDR Report Key | 8321283 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-08 |
| Date of Report | 2019-11-14 |
| Date of Event | 2019-01-06 |
| Date Mfgr Received | 2019-10-18 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-02-08 |
| 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 | 2019-02-08 |
| Model Number | M00202175824P0 |
| Catalog Number | M00202175824P0 |
| Lot Number | 18H01 |
| 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 | 2019-02-08 |