INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLE
Report
- Report Number
- 3008262715-2025-00003
- Event Type
- Death
- Date Received
- November 26, 2025
- Date of Event
- October 9, 2025
- Report Date
- January 21, 2026
- Manufacturer
- VARIAN MEDICAL SYSTEMS
- Product Code
- NEY
- UDI-DI
- 00810563022278
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G6- TYPE OF REPORT WAS MISTAKENLY NOTED AS A 5-DAY REPORT AND SHOULD HAVE BEEN AN INITIAL REPORT.
THIS SUPPLEMENTAL SUBMISSION IS PROVIDED TO FORMALLY CORRECT INFORMATION PREVIOUSLY REPORTED REGARDING THE CAUSE OF DEATH. THE CAUSE OF DEATH WAS BASED ON PRELIMINARY DATA AVAILABLE AT THE TIME OF THE INITIAL SUBMISSION AND HAS NOT BEEN SUBSTANTIATED; THEREFORE, THIS INFORMATION HAS BEEN REMOVED. ADDITIONALLY, THIS SUPPLEMENTAL SUBMISSION INCLUDES UPDATED DETAILS OBTAINED UPON COMPLETION OF THE INVESTIGATION. THE INVESTIGATION AND CORRESPONDING INVESTIGATION CODES WERE FINALIZED AT INVESTIGATION CLOSURE ON DECEMBER 22, 2025. CORRECTED: B5 - DESCRIBE EVENT OR PROBLEM HAS BEEN UPDATED TO REMOVE THE CAUSE OF DEATH AND TO ADD A STATEMENT NOTING THAT INFORMATION WAS PROVIDED BY THE TREATING PHYSICIAN. LANGUAGE UPDATED FROM ¿PREFERRED¿ TO ¿MORE CONDUCTIVE¿ WAS IMPLEMENTED TO AVOID UNINTENDED IMPLICATION OF A SINGULAR OR UNIVERSALLY OPTIMAL ROUTE. G1 - THE MANUFACTURER ADDRESS HAS BEEN CORRECTED. H6 - INVESTIGATION CODES HAVE BEEN ADDED/UPDATED TO REFLECT THE COMPLETED EVALUATION. MANUFACTURER NARRATIVE INCLUDES AN UPDATE TO REMOVE THE CAUSE OF DEATH AND ADDITIONAL NARRATIVE RELATED TO INVESTIGATION CONCLUSION: VARIAN RECEIVED AN INITIAL REPORT ON OCTOBER 28, 2025, REGARDING UNEXPECTED INTELLIBLATE ABLATIONS DURING A Y90 SALVAGE PROCEDURE. ADDITIONAL DETAILS WERE REQUESTED AND OBTAINED IN PERSON BY VARIAN STAFF AT THE CUSTOMER SITE ON NOVEMBER 25, 2025. THE FOLLOWING DETAILS OF THE SURGERY WERE PROVIDED BY THE TREATING PHYSICIAN: DUAL PROBES WERE USED AT THE INITIAL LIVER TARGET WITHOUT ISSUE. THE PROBES WERE THEN REPOSITIONED FOR A COMBINED 160W, 3-MINUTE ABLATION IN A PREVIOUSLY TREATED Y90 BED. POST-ABLATION, THROMBOSIS OF THE HEPATIC ARTERY, AND VEIN OCCURRED AT THE LIVER PEDICLE. THE PATIENT EXPIRED FIVE DAYS POST ABLATION. INVESTIGATION INTO THE DEVICE DETERMINED THE ADVERSE EVENT WAS NOT DUE TO THE PERFORMANCE OF THE INTELLIBLATE SYSTEM AND THE XPA PROBES BUT APPEARS TO HAVE RESULTED FROM THE CIRCUMSTANCE OF THE ABLATION CASE.
VARIAN RECEIVED AN INITIAL REPORT ON OCTOBER 28, 2025 REGARDING UNEXPECTED INTELLIBLATE ABLATIONS DURING A Y90 SALVAGE PROCEDURE. ADDITIONAL DETAILS WERE REQUESTED AND OBTAINED IN PERSON BY VARIAN STAFF AT THE CUSTOMER SITE ON NOVEMBER 25, 2025. ACCORDING TO THE TREATING PHYSICIAN, DUAL PROBES WERE USED AT THE INITIAL LIVER TARGET WITHOUT ISSUE. THE PROBES WERE THEN REPOSITIONED FOR A COMBINED 160W, 3-MINUTE ABLATION IN A PREVIOUSLY TREATED Y90 BED. POST-ABLATION, THROMBOSIS OF THE HEPATIC ARTERY AND VEIN OCCURRED AT THE LIVER PEDICLE. THE PATIENT EXPIRED FIVE DAYS LATER DUE TO ISCHEMIC BOWEL, SUSPECTED TO BE RELATED TO SYSTEMIC HYPOPERFUSION. THE REPORTED SERIOUS ADVERSE EVENT INCLUDES HEPATIC ARTERY/VEIN THROMBOSIS AND SUBSEQUENT DEATH. INVESTIGATION INTO DEVICE INVOLVEMENT, PERFORMANCE, AND POTENTIAL CONTRIBUTING FACTORS IS ONGOING.
SEE COMPLETED MW-2025-0014 AND MFR 3008262715-2025-00003.
ON 28/OCT/2025, VARIAN REPRESENTATIVES MET WITH THE TREATING PHYSICIAN TO DISCUSS UNEXPECTED ABLATION RESULTS NOTED DURING A PROCEDURE. FOLLOW-UP WITH THE TREATING PHYSICIAN ON (B)(6) 2025 CONFIRMED THE PATIENT HAD EXPIRED DIED 5 DAYS POST ABLATION SURGERY. THE FOLLOWING DETAILS OF THE SURGERY WERE PROVIDED BY THE TREATING PHYSICIAN: MULTIFOCAL CHOLANGIOCARCINOMA - PATIENT WAS TREATED WITH TWO NEEDLES. PT HAD MULTIPLE ABLATIONS. FIRST ABLATION WAS NORMAL. SECOND ABLATION REQUIRED REPOSITIONING TO BE AWAY FROM BOWEL DUCTS. TREATED AT 160 WATTS FOR 3 MINS. ABLATION TOOK A MORE CONDUCTIVE ROUTE TO Y90 BED CAUSING PORTAL VEIN AND HEPATIC ARTERY THROMBOSIS. THE PATIENT WHO WAS PREVIOUSLY NOT A TRANSPLANT CANDIDATE IS NOW A CANDIDATE AND IS UNABLE TO MAKE IT TO THE TRANSPLANT DUE TO ISCHEMIC BOWEL. PATIENT DIED 5 DAYS POST ABLATION.
ON 28/OCT/25, VARIAN REPRESENTATIVES MET WITH THE TREATING PHYSICIAN TO DISCUSS UNEXPECTED ABLATION RESULTS NOTED DURING A PROCEDURE. FOLLOW-UP WITH THE TREATING PHYSICIAN ON (B)(6) 2025 CONFIRMED THE PATIENT HAD EXPIRED 5 DAYS POST ABLATION SURGERY. THE DETAILS OF THE SURGERY WERE PROVIDED: MULTIFOCAL CHOLANGIOCARCINOMA - PATIENT WAS TREATED WITH TWO NEEDLES. PT HAD MULTIPLE ABLATIONS. FIRST ABLATION WAS NORMAL. SECOND ABLATION REQUIRED REPOSITIONING TO BE AWAY FROM BOWEL DUCTS. TREATED AT 160 WATTS FOR 3 MINS. ABLATION TOOK PREFERRED ROUTE TO Y90 BED CAUSING PORTAL VEIN AND HEPATIC ARTERY THROMBOSIS. THE PATIENT WHO WAS PREVIOUSLY NOT A TRANSPLANT CANDIDATE IS NOW A CANDIDATE AND IS UNABLE TO MAKE TO THE TRANSPLANT DUE TO ISCHEMIC BOWEL. PATIENT DIED 5 DAYS POST ABLATION. PATIENT DIED LIKELY DUE TO SYSTEMIC HYPOPERFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2783071 | INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLE | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES | NEY | VARIAN MEDICAL SYSTEMS | HIB0093 | INT0086 | 00810563022278 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |