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 2019-05-09 for VENOVO VENOUS STENT SYSTEM VENEL14100 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[144606179]
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.
Patient Sequence No: 1, Text Type: N, H10
[144606180]
It was reported that a few weeks after successful stent placement the patient was identified with an alleged arm swelling. It was further reported that venograms revealed an alleged stent fracture; therefore, two additional interventions were necessary with additional pta angioplasty. Reportedly, no further treatment has been administered post second intervention. The patient is stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2019-00065 |
| MDR Report Key | 8596598 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-09 |
| Date of Report | 2019-09-17 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-09-14 |
| Device Manufacturer Date | 2017-02-17 |
| Date Added to Maude | 2019-05-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | VENOVO VENOUS STENT SYSTEM |
| Generic Name | VENOUS STENT SYSTEM |
| Product Code | QAN |
| Date Received | 2019-05-09 |
| Catalog Number | VENEL14100 |
| Lot Number | ANBP0895 |
| Device Expiration Date | 2019-02-08 |
| 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. Required No Informationntervention | 2019-05-09 |