MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for HEMASHIELD manufactured by Intervascular Sas.
[188140287]
Implant date left empty because the implanted date is unknown, however the product was implanted more than 10 years ago. Device is not accessible as it remained implanted. An attempt to contact the author is ongoing. The investigation is still ongoing. A follow up report will be sent upon completion of the investigation. "web address location for the article : https://onlinelibrary. Wiley. Com/doi/abs/10. 1002/ccd. 28389.
Patient Sequence No: 1, Text Type: N, H10
[188140288]
(b)(4). This is a published case report of a (b)(6) with a posterio-malaligned ventricular septal defect (vsd) and type b interrupted aortic arch with aberrant right subclavian artery (rsca) that was initially repaired in infancy. Subsequently, he underwent dacron patch repair of recurrent transverse aortic arch obstruction and placement of a 14 mm hemashield dacron jump graft from the ascending aorta to thoracic descending aorta. The patient was lost to follow-up for 10 years. He presented with chest pain, lower extremity claudication, and severe upper extremity hypertension. Echography and catheterization showed the dacron jump graft was patent at its proximal takeoff, but tortuous and severely stenotic at its distal insertion into the thoracic aorta. A covered stent was used to treat the graft stenosis. The patient had an uneventful recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2020-00206 |
| MDR Report Key | 9783303 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-07-05 |
| Date Facility Aware | 2020-02-07 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-03 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Manufacturer Contact | MS. DOROTA WOLPIUK |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMASHIELD |
| Generic Name | GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE |
| Product Code | MAL |
| Date Received | 2020-03-03 |
| Model Number | HEMASHIELD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2020-03-03 |