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 2020-01-02 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[173704631]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[173704632]
Patient had entire great saphenous vein (gsv) treated with venaseal during a late afternoon procedure. No images were recorded during the procedure. The procedure was completed as per ifu. 2 days later the patient presented at the hospital and had a venous ultrasound which did not show any dvt. 30 minutes post ultrasound the patient had a computed tomography angiography (cta) scan which showed a pe. The scan revealed moderate acute bilateral pulmonary emboli with evidence of mild right heart strain. No further information reported.
Patient Sequence No: 1, Text Type: D, B5
[188281107]
Additional information: patient had essentially normal exam except venous insufficiency findings. Patient had no cardiovascular or pulmonary history prior to this event. Patient was hospitalized and treated with iv heparin followed by eliquis on discharge. All venous ultrasounds done showed no thrombus in superficial or deep veins. Patient status is improved. Patient will be referred to haematology regarding possible hypercoagulable state. No further patient injury was reported for this event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00015 |
| MDR Report Key | 9537592 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2018-12-19 |
| Date Added to Maude | 2020-01-02 |
| 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 | 2020-01-02 |
| Catalog Number | VS-402 |
| Lot Number | 53940 |
| 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 | 2020-01-02 |