MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-05 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[177765916]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177765917]
Patient received venaseal treatment of the great saphenous vein (gsv). Ifu was followed. 1 segment was treated, and the vein is reported to have closed. An ultrasound carried out one-week post procedure showed a class 2 non-occlusive thrombus distal to the common femoral junction (cfj). Patient was prescribed xarelto for 3 months. The physician believes this may not be due to venaseal migration as ultrasound was compared with images which were taken right after the procedure which show that cfj was clear of any thrombus or foreign body. No further patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[182473025]
Additional information: the patient is doing well and is being monitored. The physician estimates that no further action will be required. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188587752]
Image review: three cines were received for evaluation. Per the cines, it was observed "thrombus extension? Into the deep system of the gsv. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00560 |
| MDR Report Key | 9669589 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-05 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-03-30 |
| Date Added to Maude | 2020-02-05 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENA SEAL CLOSURE SYSTEM |
| Generic Name | AGENT, OCCLUDING, VASCULAR, PERMANENT |
| Product Code | PJQ |
| Date Received | 2020-02-05 |
| Catalog Number | VS-402 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-05 |