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 2020-02-24 for COVERA PLUS VASCULAR COVERED STENT SYSTEM UNK COVERA PLUS manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[182333475]
The catalog number identified has not been cleared in the us but is similar to the covera vascular stent graft products that are cleared in the us. The 510 k number and pro code for the covera vascular 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: gennai, s. , antonello, m. , leone, n. , migliari, m. , andreoli, f. , dall? Antonia, a. ,? Silingardi, r. (2019). Early experience with the covera stent graft as a bridging stent in branched thoraco-abdominal endovascular aneurysm repairs. Journal of vascular and interventional radiology, 30(12), 1949? 1955. Doi: 10. 1016/j. Jvir. 2019. 08. 006. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182333476]
It was reported in an article from the journal of vascular and international radiology (jvir) titled " early experience with the covera stent graft as a bridging stent in branched thoraco-abdominal endovascular aneurysm repairs " that after stent graft placement, on 30-day computed tomography angiography (cta) one type ic and four type ii endoleaks were diagnosed; type ic endoleak was successfully corrected with a distal extension. One patient with upper limb ischemia was corrected with endoluminal thrombectomy and stenting of the previous axillary access and another patient with splenic hemorrhage was managed with the deployment of a covered stent. Spinal cord ischemia was identified in 2 patients and contrast induced acute kidney injury was identified in 3 patients; 2 partially recovers and 1 required dialysis. The status of the patients was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2020-00052 |
| MDR Report Key | 9746612 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-07-06 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-24 |
| 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 PLUS VASCULAR COVERED STENT SYSTEM |
| Generic Name | VASCULAR COVERED STENT |
| Product Code | PFV |
| Date Received | 2020-02-24 |
| Catalog Number | UNK COVERA PLUS |
| 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; 2. Required No Informationntervention | 2020-02-24 |