ICEFORCE 2.1 CX

Additional Manufacturer Narrative

A2: AGE AT TIME OF EVENT: THE MEAN AGE AT THE TIME OF TREATMENT WAS 64 YEARS. A3: SEX: THE PERCENTAGE OF FEMALES IN THE STUDY WAS 65%. B3: DATE OF EVENT: THE EVENT DATE WAS ESTIMATED TO THE EARLIEST KNOWN PROCEDURE INCLUDED IN THE STUDY. D3: MANUFACTURER ADDRESS 1: TAVOR BUILDING 1, INDUSTRIAL PARK. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WESTPHAL, J. A., GRAUR, A., AND FINTELMANN, F. J. (2025). INTERCOSTAL NERVE PROTECTION USING EXTRAPLEURAL AIR DURING PERCUTANEOUS CRYOABLATION OF PERIPHERAL LUNG TUMORS. RADIOLOGY: CARDIOTHORACIC IMAGING, 7(5), E250057. HTTPS://DOI.ORG/10.1148/RYCT.250057.

Description of Event or Problem

IT WAS REPORTED THAT PATIENTS EXPERIENCED A RANGE OF ADVERSE EVENTS FOLLOWING CRYOABLATION PROCEDURES. THIS WAS A RETROSPECTIVE SINGLE-CENTER INTERVENTIONAL COHORT STUDY WITH A GOAL TO ASSESS THE FEASIBILITY OF EXTRA-PLEURAL AIR INJECTION AS A SIMPLE TECHNIQUE TO PROTECT INTERCOSTAL NERVES AGAINST THERMAL INJURY DURING IMAGE-GUIDED PERCUTANEOUS CRYOABLATION OF PERIPHERAL LUNG TUMORS. THIS STUDY ANALYZED DATA FROM 26 PATIENTS WHO UNDERWENT 27 CRYOABLATION PROCEDURES OF 31 PERIPHERAL LUNG TUMORS COMBINED WITH AIR INJECTION DEEP TO THE ENDOTHORACIC FASCIA BETWEEN AUGUST 2022 AND NOVEMBER 2024. CRYOABLATIONS WERE PERFORMED BY ONE FELLOWSHIP-TRAINED RADIOLOGIST WITH 10 YEARS OF EXPERIENCE IN PERCUTANEOUS LUNG ABLATION USING THE ICEFX CRYOABLATION SYSTEM FROM BOSTON SCIENTIFIC WITH 14-GAUGE (ICEPEARL 2.1 CX OR ICEFORCE 2.1 CX; BOSTON SCIENTIFIC) AND 17-GAUGE (ICESPHERE 1.5 CX; BOSTON SCIENTIFIC) CRYOPROBES. PATIENTS WERE SCREENED FOR ADVERSE EVENTS AT 1 DAY, 1 WEEK, AND 1 MONTH AFTER ABLATION USING A STRUCTURED QUESTIONNAIRE. INTERCOSTAL NEURALGIA WAS DEFINED AS NEW POST-ABLATION BANDLIKE IPSILATERAL CHEST WALL NUMBNESS MATCHING THE DERMATOME OF AN INTERCOSTAL NERVE ADJACENT TO THE CRYOABLATION ZONE FOLLOWED BY PAIN WITH OR WITHOUT DYSESTHESIA IN THE SAME DISTRIBUTION. ADVERSE EVENTS WITHIN 30 DAYS FOLLOWING LUNG CRYOABLATION WERE PROSPECTIVELY RECORDED AND CLASSIFIED ACCORDING TO THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) VERSION 5.0. ADVERSE EVENTS OCCURRED AFTER 20 OF 27 (74%) SESSIONS DURING THE 30-DAY OBSERVATION PERIOD. ADVERSE EVENTS OCCURRED WITHIN 3 HOURS AFTER ABLATION IN 6/27 SESSIONS (22%), 3-24 HOURS AFTER ABLATION IN 12/27 SESSIONS (44%), 1-7 DAYS AFTER ABLATION IN 7/27 SESSIONS (26%), AND 7-30 DAYS AFTER ABLATION IN 1/27 SESSIONS (4%). MORE THAN ONE ADVERSE EVENT MAY HAVE OCCURRED IN A SINGLE SESSION. THE MOST COMMON ADVERSE EVENTS WERE GRADE 1-2 HEMOPTYSIS (13/27, 48%), GRADE 1-2 PAIN (10/27, 37%), AND GRADE 1-2 PNEUMOTHORAX (6/27, 22%), INCLUDING THREE PNEUMOTHORAXES REQUIRING CHEST TUBE PLACEMENT. PAIN OCCURRED 3-24 HOURS AFTER ABLATION IN 7/27 (26%) SESSIONS, WITHIN 1-7 DAYS AFTER ABLATION IN TWO SESSIONS (7%), AND 7-30 DAYS AFTER ABLATION IN A SINGLE SESSION (4%). PAIN WAS CLASSIFIED AS GRADE 1 IN SEVEN (26%) SESSIONS AND AS GRADE 2 IN THREE (11%) SESSIONS. GRADE 3 EVENTS OCCURRED IN 1/27 (4%) SESSIONS, INCLUDING PAIN LIMITING ACTIVITIES OF DAILY LIVING. GRADE 1 INTERCOSTAL NEURALGIA OCCURRED IN ONE PATIENT FOR WHOM AIR WAS INJECTED UNSUCCESSFULLY. NEURALGIA STARTED TO DEVELOP 7 DAYS AFTER ABLATION. THE PATIENT DID NOT REPORT NEURALGIA DURING OR IMMEDIATELY AFTER ABLATION. THE PATIENT HAD PREVIOUSLY UNDERGONE IPSILATERAL LUNG RESECTION.