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 2020-01-16 for FLUENCY PLUS VASCULAR STENT GRAFT FVM14040 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[177153656]
As the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. The catalog number identified has not been cleared in the u. S. But, it is similar to the fluency plus endovascular stent graft products that are cleared in the us. The 510 k number and pro code for the fluency plus endovascular stent graft products are identified. (expiry date: 09/2022).
Patient Sequence No: 1, Text Type: N, H10
[177153657]
It was reported that post stent graft placement in the superior vena cava via right basilic vein, the ring at the tip of the delivery system detached and migrated to a small branch of the pulmonary artery. It was further reported that unsuccessful attempts were made to recover the fragment with a lasso; the device fragment currently remains in the patient. No clinical consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2019-00260 |
| MDR Report Key | 9599210 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-16 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-10-31 |
| Date Added to Maude | 2020-01-16 |
| 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 | FLUENCY PLUS VASCULAR STENT GRAFT |
| Generic Name | VASCULAR STENT GRAFT |
| Product Code | PFV |
| Date Received | 2020-01-16 |
| Returned To Mfg | 2020-02-18 |
| Catalog Number | FVM14040 |
| Lot Number | ANDW4268 |
| 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 | 1. Other | 2020-01-16 |