MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-03-18 for COVERA VASCULAR COVERED STENT SYSTEM AVFME09060 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[187056101]
As the lot number for the device was provided, a manufacturing review will 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. (expiry date: 04/2018).
Patient Sequence No: 1, Text Type: N, H10
[187056102]
It was reported through the results of a clinical trial, approximately 1 year post index procedure, 50% stenosis lesion was identified and re-intervention was performed to treat difficulty puncturing using a standard pta balloon and final residual stenosis was 10%. It was further reported that the patient expired; however, there is no relation to the device, procedure, and av access circuit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2020-00065 |
| MDR Report Key | 9850912 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2016-04-08 |
| Date Added to Maude | 2020-03-18 |
| 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 SYSTEM |
| Generic Name | VASCULAR COVERED STENT |
| Product Code | PFV |
| Date Received | 2020-03-18 |
| Catalog Number | AVFME09060 |
| Lot Number | ANBN0972 |
| 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. Required No Informationntervention | 2020-03-18 |