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 2020-02-03 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[177361585]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177361586]
Patient received venaseal treatment of the great saphenous vein (gsv). 11 segments were treated, and the vein is reported to have closed. Procedure was completed as per ifu. It is reported the patient reported 9-10 days post implant with redness along the treated vein tract. The physician instructed the patient to use warm compresses and nsaids to treat. It is reported the symptoms continued to get worse with redness spreading to the abdomen and opposite thigh. The treating physician then prescribed a course of steroids to treat the hypersensitivity. At this time symptoms have improved.
Patient Sequence No: 1, Text Type: D, B5
[182473241]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182473854]
Additional information: the patient's condition has fully resolved and is doing well with no issues. No further patient injury. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188585734]
Additional information: the left gsv was treated and 1. 8cc of venaseal were used to treat the vessel. The hypersensitivity is almost fully resolved. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00518 |
| MDR Report Key | 9659026 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-03 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-01-15 |
| Date Added to Maude | 2020-02-03 |
| 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 | 2020-02-03 |
| Catalog Number | VS-402 |
| Lot Number | 54320 |
| 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 | 2020-02-03 |