MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-03-07 for HEMASHIELD manufactured by Intervascular Sas.
[138209212]
(b)(4). Device is not accessible for testing since it remained implanted in patient. No investigation could be performed to date since there is no graft identification available. 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
[138209213]
This is a published case report of microangiopathic hemolytic anemia and hemoglobinuric acute kidney injury (aki) presenting 9 days after repair of an ascending aortic dissection with a prosthetic graft. After an unremarkable recovery following the initial procedure, the patient presented on postoperative day 9 with dyspnea, fatigue, and cola-colored urine. A follow-up mri/a revealed a kink in the aortic graft causing turbulent blood flow. After surgical release of the kinked graft, his aki and hemolysis labs improved immediately. On follow-up, his anemia resolved, and renal function returned to baseline, although he continued to have subclinical hemolysis. The hemolysis and hemoglobinuric aki seen in this patient was directly the result of a kink in the nonvalvular prosthetic aortic graft. The authors speculate that without appropriate surgical repair the ongoing hemolysis would have led to irreversible end-stage renal disease and life-threatening transfusion-dependent anemia. The reference of the article is the following: sheelvanth hv, et al. Hemoglobinuric acute kidney injury in a patient with a kinked prosthetic aortic graft. Clin nephrol 2018;89(4):286-290.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2019-00017 |
| MDR Report Key | 8401862 |
| Report Source | LITERATURE |
| Date Received | 2019-03-07 |
| Date of Report | 2019-07-03 |
| Date Facility Aware | 2019-02-05 |
| Date Mfgr Received | 2019-06-21 |
| Date Added to Maude | 2019-03-07 |
| 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 | MAQUET CARDIOVASCULAR LLC (IMPORTER) |
| 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 | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2019-03-07 |
| Device Availability | N |
| 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 | 2019-03-07 |