MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-29 for COVERA PLUS VASCULAR COVERED STENT SYSTEM AASME09040 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[176812027]
Images and videos were provided to the manufacturer for review. The lot number for the device was provided. The device history records are currently under review. The device is not available for return. The investigation is currently underway. Medical device - expiry date: 08/2021.
Patient Sequence No: 1, Text Type: N, H10
[176812030]
It was reported that after implantation in the common iliac artery, the stent graft allegedly migrated 1-1. 5 cm and obstructed the internal iliac artery. It was further reported that another device was used to cover the entirety of the lesion. The current patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2020-00040 |
| MDR Report Key | 9642494 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-29 |
| Date of Report | 2020-02-27 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-08-21 |
| Date Added to Maude | 2020-01-29 |
| 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 | 2020-01-29 |
| Catalog Number | AASME09040 |
| Lot Number | ANDV1989 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-29 |