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 2020-02-12 for VENA SEAL CLOSURE SYSTEM manufactured by Medtronic Ireland.
[182473244]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[189009322]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[189009323]
The purpose of the a singapore venaseal real world post-market evaluation study (asvs) is to evaluate the performance of cyanoacrylate closure (cac) for varicose veins in a prospective multi-racial asian population registry from singapore. We report early clinical and patient satisfaction outcomes at 3 months post intervention. The study evaluated the technical, anatomical and clinical performance of vscs performed on multiple truncal varicose veins, and without mandatory postoperative compression stockings of the great saphenous vein (gsv), small saphenous vein (ssv) and/or anterior accessory saphenous vein (aasv). The two primary endpoints for this evaluation are technical success at the time of the procedure, and anatomical success, reported as complete closure at 2-weeks, 3, 6 and 12 months. 100 patients (151 legs; 100 procedures, 59 females and mean age was 60. 1? 12. 7 years) underwent cac between april - december 2018. 49 (32. 5%) legs were treated for great saphenous vein (gsv) incompetence, 96/151 (63. 6%) bilateral gsv, 1/151 (0. 7%) small saphenous vein (ssv) and 5 (3. 3%) combined unilateral gsv and ssv reflux. At baseline, 68/151 legs (45. 0%) had c4-c6 disease and 67/151 (44. 4%) legs had concomitant multiple stab avulsions. There was no deviation of the protocol. All gsv and ssv/atv were successfully punctured percutaneously. There were no device? Related complications and the venaseal catheter was delivered without incident to the intended position in the truncal vein in all cases (100% technical success). During treatment, transducer 2cm cranial to 5cm to allow some spread of glue cranially during plunging but probe distal to iev to allow flow and minimise thrombus extension proximally. There were no challenges or deviations related to the location of catheter tip prior to initial delivery of adhesive. The most common ae was minor bruising (<(><<)> 25% of the treated area) in 45 (45%) patients and this was typically at the puncture site at the mid calf level. These all resolved by the 3-month review. Two patients had thrombus extension that protruded 5mm into the saphenofemoral junction at the 2-week duplex ultrasound visit. These patients, although asymptomatic, were treated as a dvt with anticoagulation, and the thrombus extension was no longer evident at the 3-month duplex ultrasound scan. Twenty seven patients developed phlebitis. Most of the phlebitis was noted along the line of the treated gsv rather than its tributaries and generally more widespread in the thigh. In all cases, this was mild and self-limiting. At three-months follow-up these cases had fully resolved. One patient developed total body hives within the first 2 weeks of the procedure, consistent with cyanoacrylate allergy, which improved after treatment with antihistamines and a short course of steroids. Patients were treated with self limiting, nsaids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-00686 |
| MDR Report Key | 9699128 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-02-12 |
| 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 | 2020-02-12 |
| 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. Required No Informationntervention | 2020-02-12 |