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 2020-01-15 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[175027103]
Image review: (physician notes and photo of leg): the physician notes describe two separate patient visits with led to the approval from treatment. The notes indicate symptomatic varicose veins have been identified. The notes did not specifically indicate the varicose veins would be treated using venaseal. Final physician note indicating ablation: "plan: varicose veins of right lower extremity with pain continue aspir-81, notes: right gsv reflux. Schedule ablation. The provided photo shows a leg with necrosis at the suspected access site and proximal from access site which was identified during post procedure follow up according to the customer. Redness around the identified areas of necrosis was identified. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175027104]
Patient was treated with venaseal great saphenous vein (gsv) was treated. The vein is reported to have closed. Patient returned for follow-up appointment 5 days post implant and underwent a venous ultrasound which showed a dilated and refluxing left gsv. Patient continues to have left lower extremity aching, burning and cramping with varicosities despite conservative therapy including compression therapy, leg elevation and avoidance of prolonged sitting and standing over a period of 3 months with only partial relief reported. Patient cannot stand during the day without having to sit and elevate legs. It has been reported a reaction occurred post procedure resulting in necrosis at the access site and proximal from access site which was identified during post procedure follow up. Patient had been hospitalised for another condition. This resulted in partial explant of the cyanoacrylate at the access site and at the proximal from the access site. The patient is now reported to have open wounds at the mid and lower leg from the partial explant. Patient has been referred to a wound care centre for treatment. No further patient injuries reported
Patient Sequence No: 1, Text Type: D, B5
[188422187]
Additional information: necrosis at the access site was noticed by the physician a few days after the procedure. Access site was an open wound above the ankle. Physician note and image review: the physician notes describe two separate patient visits which led to the approval for treatment. The notes indicate symptomatic varicose veins have been identified. The provided photo shows a leg with necrosis at the suspected access site and proximal from access site which was identified during post procedure follow up according to the customer. Redness around the identified areas of necrosis was identified. Correction: patient age updated. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188422365]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00236 |
| MDR Report Key | 9590515 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-15 |
| Date of Report | 2020-02-20 |
| Date of Event | 2019-08-27 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-01-15 |
| 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 | 2020-01-15 |
| Catalog Number | VS-402 |
| Lot Number | UNK |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-15 |