VELA XL
Report
- Report Number
- 2124215-2024-15585
- Event Type
- Injury
- Date Received
- March 14, 2024
- Date of Event
- June 27, 2023
- Report Date
- June 19, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ABHAY SETIA, SLOBODAN DIKIC, SAHIT DEMHASAJ, THOMAS SCHMITZ-RIXEN, RONALD SROKA, AND CLAUS-GEORG SCHMEDT. PROSPECTS OF ENDOVENOUS LASER ABLATION (EVLA) STANDARDIZATION-MID-TERM RESULTS OF A FOUR-ZONE DOSIMETRY GUIDING TOOL FOR 1940 NM LASER. J. CLIN. MED. 2023, 12, 4313. HTTPS://DOI.ORG/10.3390/JCM12134313.
ABHAY SETIA, SLOBODAN DIKIC, SAHIT DEMHASAJ, THOMAS SCHMITZ-RIXEN, RONALD SROKA, AND CLAUS-GEORG SCHMEDT. PROSPECTS OF ENDOVENOUS LASER ABLATION (EVLA) STANDARDIZATION-MID-TERM RESULTS OF A FOUR-ZONE DOSIMETRY GUIDING TOOL FOR 1940 NM LASER. J. CLIN. MED. 2023, 12, 4313. HTTPS://DOI.ORG/10.3390/JCM12134313.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF CLINICAL MEDICINE THAT A PROSPECTIVE, NON-RANDOMIZED, OBSERVATIONAL STUDY WAS CONDUCTED TO EVALUATE THE EFFICACY OF ENDOVENOUS LASER ABLATION (EVLA) USING A 1940 NM-LASER AND RADIAL-FIBER SUPPORTED BY A FOUR-ZONE DOSIMETRY TOOL. A TOTAL OF 152 CONSECUTIVE PATIENTS FOR THE STUDY WERE RECRUITED BETWEEN 01JUN2017 AND 30JUL2019. ALL PROCEDURES WERE CONDUCTED AT THE SAME HOSPITAL. ALL PATIENTS WERE GREATER THAN 18 YEARS OLD WITH PRIMARY VARICOSE VEINS WITH INCOMPETENT TRUNCAL VEINS WITH AN OUTER DIAMETER (OD) LESS THAN OR EQUAL TO 13 MM. PATIENTS WITH OD GREATER THAN 13 MM WERE ACCEPTED ONLY WHEN THEY HAD SMALL, LOCALIZED DILATATIONS THAT INVOLVED UP TO 3 CM SEGMENTS OF THE TRUNCAL VEIN. THE EVLA PROCEDURES WERE CARRIED OUT USING A THULIUM FIBER LASER SYSTEM EMITTING AT 1940NM, IN COMBINATION WITH A RADIAL EMITTING FIBER SYSTEM. THERE WERE NO INTRAOPERATIVE COMPLICATIONS OBSERVED. FOLLOW-UP EXAMINATIONS WERE PERFORMED WITHIN 1 MONTH, AND AT OR AFTER 12 MONTHS. WITHIN THE ONE-MONTH FOLLOW-UP PERIOD, 4 PATIENTS EXPERIENCED LASER-INDUCED PARAESTHESIA IN THE INNERVATION AREAS OF THE SAPHENOUS NERVE BELOW THE KNEE. THIS REGRESSED IN THREE PATIENTS AT 12 MONTHS AND WAS PERSISTENT BELOW THE KNEE IN ONE PATIENT. WITHIN THE ONE-MONTH FOLLOW-UP PERIOD, FOUR PATIENTS EXPERIENCED MECHANICALLY INDUCED PARAESTHESIA IN REGIONS OF MINI-PHLEBECTOMY INCISIONS ACCOMPANYING THE EVLA PROCEDURES. THIS WAS PERSISTENT IN ONE PATIENT AT THE 12-MONTH FOLLOW-UP VISIT. WITHIN THE ONE-MONTH FOLLOW-UP PERIOD, 10 PATIENTS HAD MECHANICALLY INDUCED HEMATOMAS IN REGIONS OF THE MINI-PHLEBECTOMY INCISIONS. FIVE OF THESE INVOLVED THE THIGH AND 5 INVOLVED THE LOWER LEG. ALL OF THE HEMATOMAS HAD REGRESSED AT THE 12-MONTH FOLLOW-UP VISIT. ENDOVENOUS HEAT-INDUCED THROMBOSIS (EHIT) WAS OBSERVED IN 3 PATIENTS WITHIN ONE MONTH. ALL OF THESE PATIENTS RECEIVED THERAPEUTIC ANTICOAGULATION AND WERE FOLLOWED-UP WEEKLY. EHIT WAS NO LONGER PRESENT AT THE 12-MONTH FOLLOW-UP VISIT. THERE WERE TWO PATIENTS WHO EXPERIENCED EARLY ANATOMICAL FAILURE OF THE EVLA PROCEDURE, WHICH WAS DEFINED AS NON-OCCLUSION. AT THE 12-MONTH FOLLOW-UP VISIT, EIGHT PATIENTS WERE DEVELOPING RECANALIZATION. OVERALL, PATIENTS EXPERIENCED SUCCESSFUL PROCEDURES WITH 98.9% OCCLUSION AT THE 1-MONTH FOLLOW-UP VISIT AND 93.7% OCCLUSION AT THE 12-MONTH FOLLOW-UP VISIT.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF CLINICAL MEDICINE THAT A PROSPECTIVE, NON-RANDOMIZED, OBSERVATIONAL STUDY WAS CONDUCTED TO EVALUATE THE EFFICACY OF ENDOVENOUS LASER ABLATION (EVLA) USING A 1940 NM-LASER AND RADIAL-FIBER SUPPORTED BY A FOUR-ZONE DOSIMETRY TOOL. A TOTAL OF 152 CONSECUTIVE PATIENTS FOR THE STUDY WERE RECRUITED BETWEEN 01JUN2017 AND 30JUL2019. ALL PROCEDURES WERE CONDUCTED AT THE SAME HOSPITAL. ALL PATIENTS WERE GREATER THAN 18 YEARS OLD WITH PRIMARY VARICOSE VEINS WITH INCOMPETENT TRUNCAL VEINS WITH AN OUTER DIAMETER (OD) LESS THAN OR EQUAL TO 13 MM. PATIENTS WITH OD GREATER THAN 13 MM WERE ACCEPTED ONLY WHEN THEY HAD SMALL, LOCALIZED DILATATIONS THAT INVOLVED UP TO 3 CM SEGMENTS OF THE TRUNCAL VEIN. THE EVLA PROCEDURES WERE CARRIED OUT USING A THULIUM FIBER LASER SYSTEM EMITTING AT 1940NM, IN COMBINATION WITH A RADIAL EMITTING FIBER SYSTEM. THERE WERE NO INTRAOPERATIVE COMPLICATIONS OBSERVED. FOLLOW-UP EXAMINATIONS WERE PERFORMED WITHIN 1 MONTH, AND AT OR AFTER 12 MONTHS. WITHIN THE ONE-MONTH FOLLOW-UP PERIOD, 4 PATIENTS EXPERIENCED LASER-INDUCED PARAESTHESIA IN THE INNERVATION AREAS OF THE SAPHENOUS NERVE BELOW THE KNEE. THIS REGRESSED IN THREE PATIENTS AT 12 MONTHS AND WAS PERSISTENT BELOW THE KNEE IN ONE PATIENT. WITHIN THE ONE-MONTH FOLLOW-UP PERIOD, FOUR PATIENTS EXPERIENCED MECHANICALLY INDUCED PARAESTHESIA IN REGIONS OF MINI-PHLEBECTOMY INCISIONS ACCOMPANYING THE EVLA PROCEDURES. THIS WAS PERSISTENT IN ONE PATIENT AT THE 12-MONTH FOLLOW-UP VISIT. WITHIN THE ONE-MONTH FOLLOW-UP PERIOD, 10 PATIENTS HAD MECHANICALLY INDUCED HEMATOMAS IN REGIONS OF THE MINI-PHLEBECTOMY INCISIONS. FIVE OF THESE INVOLVED THE THIGH AND 5 INVOLVED THE LOWER LEG. ALL OF THE HEMATOMAS HAD REGRESSED AT THE 12-MONTH FOLLOW-UP VISIT. ENDOVENOUS HEAT-INDUCED THROMBOSIS (EHIT) WAS OBSERVED IN 3 PATIENTS WITHIN ONE MONTH. ALL OF THESE PATIENTS RECEIVED THERAPEUTIC ANTICOAGULATION AND WERE FOLLOWED-UP WEEKLY. EHIT WAS NO LONGER PRESENT AT THE 12-MONTH FOLLOW-UP VISIT. THERE WERE TWO PATIENTS WHO EXPERIENCED EARLY ANATOMICAL FAILURE OF THE EVLA PROCEDURE, WHICH WAS DEFINED AS NON-OCCLUSION. AT THE 12-MONTH FOLLOW-UP VISIT, EIGHT PATIENTS WERE DEVELOPING RECANALIZATION. OVERALL, PATIENTS EXPERIENCED SUCCESSFUL PROCEDURES WITH 98.9% OCCLUSION AT THE 1-MONTH FOLLOW-UP VISIT AND 93.7% OCCLUSION AT THE 12-MONTH FOLLOW-UP VISIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2077367 | VELA XL | POWERED LASER SURGICAL INSTRUMENT | GEX | BOSTON SCIENTIFIC CORPORATION | UNK-P-VELA_XL_4101_CONSOLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |