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 2020-02-13 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[179425364]
Event date: month and year valid. Implant date: month and year valid. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179425365]
Patient underwent bilateral great saphenous vein (gsv) treatment. 10 days post index procedure the had patient presented with swelling, erythema, and pain and was treated with antihistamines. Approximately 2 years post venaseal implant the patient experienced the same symptoms of swelling, erythema, and pain and was treated with antibiotics for 10 days by a family doctor. Patient visited a vein clinic approximately 3 years and 4 months post venaseal implant presenting with symptoms of swelling, erythema, and pain in superficial segment of the gsv. The patient was treated with antihistamines to treat the pain and tenderness and the symptoms resolved in 3 days.
Patient Sequence No: 1, Text Type: D, B5
[188632105]
Additional information: the patient complained of varicose veins of both legs, where there was swelling and night cramps. The patient was diagnosed with venous insufficiency. The physician planned to treat with venaseal. The physician conducted a duplex ultrasound and found the id to be to be 7. 2mm and 5. 1 mm, with varicose veins of the lateral branches, swelling of both legs. Procedure was successful, the procedure and immediate postoperative period had no issues. The patient was in good general condition the next day and was discharged from the hospital for further outpatient rehabilitation. The physician prescribed bandages and control in bkv, repeated control in keb, and medication of powder nimesi twice daily for 7 days, 2 detralex daily for 2 months, xarelto daily for 5 days. For when allergic reactions appear on the skin along the veins, the patient was prescribed rupafin daily for 7 days. The patient noticed a thickened vein in lower leg from the venaseal treatment about 4 months and 6 months later. The patient had returned back to the same hospital about 25 months after the procedure, with complaints of being ill with acute respiratory viral infection (arvi) 3 weeks prior, where ant ibiotics were prescribed. It was concluded that, from the venaseal procedure, there was varicose vein of the abu kaju reticular vein. The physician performed a foam sclerotherapy on both feet with aethoxysclerol (0. 5%). The procedure for both legs were teleangiectasis. The procedure was reported to be successful. No thrombotic mass was noted in the lumen. The patient went to another clinic about 13 months later, where the physician there had marked vein in red where plar was observed. According to the physician, the patient had swelling, erythema, and pain. The patient was treated with antihistamines and nsaids for 3 days and the symptoms were reported to have disappeared. The physician has planned another examination to see how the patient is currently doing. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188632274]
Additional information: the antihistamines were prescribed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00701 |
| MDR Report Key | 9705230 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-02-13 |
| 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 | 2020-02-13 |
| 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 | 2020-02-13 |