MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for VENOVO VENOUS STENT SYSTEM VENEM12060 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[143586568]
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. The catalog number identified in section d4 has not been cleared in the u. S. But, it is similar to the venovo venous stent products that are cleared in the us. The 510 k number and pro code for the venovo venous stent products are identified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[143586569]
It was reported that a segment of the sheath of the delivery system allegedly detached during the stent placement procedure. Reportedly, the delivery system was removed and the procedure was halted. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2019-00062 |
| MDR Report Key | 8558725 |
| Date Received | 2019-04-26 |
| Date of Report | 2019-06-05 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-06-04 |
| Device Manufacturer Date | 2018-11-15 |
| Date Added to Maude | 2019-04-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 1625 W 3RD ST. |
| 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 | 0 |
| Brand Name | VENOVO VENOUS STENT SYSTEM |
| Generic Name | VENOUS STENT SYSTEM |
| Product Code | QAN |
| Date Received | 2019-04-26 |
| Returned To Mfg | 2019-04-18 |
| Catalog Number | VENEM12060 |
| Lot Number | ANCX1874 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-26 |