MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-02-18 for COVERA VASCULAR COVERED STENT UNK COVERA manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[182331261]
The catalog number identified has not been cleared in the us but is similar to the covera stent graft products that are cleared in the us. The 510 k number and pro code for the covera stent graft products are identified. As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. Journal article citation: caradu, c. , dubourg, a. P. , colacchio, e. C. , midy, d. , b? Rard, x. , & ducasse, e. (2019). Endovascular treatment of complex aneurysms with the use of covera stent grafts. Journal of vascular and interventional radiology, 30(12). Doi: 10. 1016/j. Jvir. 2019. 05. 004.
Patient Sequence No: 1, Text Type: N, H10
[182331262]
It was reported in an article from the journal of vascular and interventional radiology (jvir) titled " endovascular treatment of complex aneurysms with the use of covera stent grafts " that after the stent graft placement, immediate postoperative aphasia identified in one patient with complete recovery and it was associated with the use of bilateral brachial approach for the implantation of 3 chimneys and the navigation through the aortic arch by larger catheter sheath. In one patient, persistent type ia "short" gutter endoleak remained under surveillance with the stability of the sac at 49 mm at 2 months follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2020-00049 |
| MDR Report Key | 9720594 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-02-05 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-18 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Street | WACHHAUSSTRASSE 6 |
| Manufacturer City | KARLSRUHE 76227 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COVERA VASCULAR COVERED STENT |
| Generic Name | VASCULAR COVERED STENT |
| Product Code | PFV |
| Date Received | 2020-02-18 |
| Catalog Number | UNK COVERA |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Address | WACHHAUSSTRASSE 6 KARLSRUHE 76227 GM 76227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-18 |