MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-19 for VENOVO VENOUS STENT SYSTEM VENUM16080 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[179108160]
The lot number for the device was provided. The device history records are currently under review. The device has been returned for evaluation. The investigation is currently underway.
Patient Sequence No: 1, Text Type: N, H10
[179108161]
It was reported that during a stent placement in the left common iliac vein via left common femoral approach, the stent allegedly failed to deploy more than 50%. Reportedly, a glove was caught in transition when the second catheter went into the third catheter. It was further reported that a hemostat was used to open the device and manually deploy the stent. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2019-00226 |
| MDR Report Key | 9344741 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-19 |
| Date of Report | 2019-11-19 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2019-10-23 |
| Device Manufacturer Date | 2019-09-13 |
| Date Added to Maude | 2019-11-19 |
| 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 |
| Product Code | QAN |
| Date Received | 2019-11-19 |
| Returned To Mfg | 2019-11-08 |
| Model Number | VENUM16080 |
| Catalog Number | VENUM16080 |
| Lot Number | ANDV1267 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-11-19 |