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 2020-02-11 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[182473603]
Image review: two images were returned for evaluation. The 1st image appears to be dilated proximal segment of a gsv. The image does not clearly show thrombus given the quality. The 2nd image shows what appears to be non-occlusive thrombus at the saphenofemoral junction. The non-occlusive thrombus may have slightly extended into the common femoral vein. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[189007981]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[189007982]
Physician use venaseal occluding device during procedure to treat 2 segments in the great saphenous vein and anterior accessory great saphenous vein (gsv and aagsv). Local anesthesia was used. The lumen was flushed prior to use. The ifu was followed during preparation, procedure and post procedure. A guide wire was used for the insertion of the catheter. The procedure was finished per ifu. It was reported that during the initial follow up scan 2 days post procedure clot/thrombus was noted. The area that was treated was reported to be very swollen and the patient was unable to bend the leg that was treated. Mild erythema and warmth to the right leg noted. The physician prescribed a prednisone dose pack, oral pills, for the patient's treatment. Patient on xarelto also. The patient's condition has been reported to have been resolved a week after and the follow up scan revealed no deep vein thrombus left. There was no further patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-00654 |
| MDR Report Key | 9691579 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-02-11 |
| 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 | 2020-02-11 |
| 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 | 2020-02-11 |