MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-13 for VENOVO VENOUS STENT SYSTEM VENUL14140 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[179109882]
Two medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The device was not returned for evaluation. The investigation is currently underway. (expiry date: 01/2021).
Patient Sequence No: 1, Text Type: N, H10
[179109883]
It was reported that during treatment of the left common iliac and left external iliac vein via great saphenous vein, after the stent had begun to deploy, the healthcare provider (hcp) realized that the stent should be placed lower and attempted to move the stent to the desired location; however, the movement caused the stent to allegedly fracture into two segments. Therefore, the stent was completely deployed in the external iliac and common femoral vein. It was further reported that a pta balloon and an additional stent of a different size were used to cover the entirety of the lesion, completing the procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2019-00215 |
| MDR Report Key | 9317452 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-13 |
| Date of Report | 2019-11-13 |
| Date of Event | 2019-10-17 |
| Date Mfgr Received | 2019-10-17 |
| Device Manufacturer Date | 2019-02-11 |
| Date Added to Maude | 2019-11-13 |
| 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 | VENOVO VENOUS STENT SYSTEM |
| Generic Name | VENOUS STENT |
| Product Code | QAN |
| Date Received | 2019-11-13 |
| Model Number | VENUL14140 |
| Catalog Number | VENUL14140 |
| Lot Number | ANDN1805 |
| 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 | 2019-11-13 |