DRAGONFLY

Additional Manufacturer Narrative

THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

THE FOLLOWING WAS PUBLISHED IN CIRCULATION JOURNAL : OFFICIAL JOURNAL OF THE JAPANESE CIRCULATION SOCIETY TITLED "VENTRICULAR FIBRILLATION DURING OPTICAL COHERENCE TOMOGRAPHY/OPTICAL FREQUENCY DOMAIN IMAGING - A LARGE SINGLE-CENTER EXPERIENCE" BY TERADA, NORIKO ET AL.: A TOTAL OF 31 CASES OF VFIB OCCURRED IN 30 PATIENTS (PER PATIENT, 30/1,754 [1.7%]; PER PULLBACK, 31/4,467 [0.69%]). THE INCIDENCE OF VFIB PER PATIENT WAS 1.6% (14/855) DURING DIAGNOSTIC CATHETERIZATION, 2.2% (12/538) DURING ELECTIVE PCI, AND 1.1% (4/361) DURING PRIMARY OR EMERGENCY PCI (P=0.466). (DOI:10.1252/CIRCJ.CJ-19-0736).

Additional Manufacturer Narrative

THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

Description of Event or Problem

THE RISKS OF VENTRICULAR FIBRILLATION (VFIB) ASSOCIATED WITH FREQUENCY-DOMAIN OPTICAL COHERENCE TOMOGRAPHY (OCT)/OPTICAL FREQUENCY DOMAIN IMAGING (OFDI) REMAIN UNDETERMINED. THE OCCURRENCE OF VFIB DURING OCT/OFDI FOR UNSELECTED INDICATIONS WAS RETROSPECTIVELY STUDIED AND THE FREQUENCY OF VFIB AND PATIENT AND PROCEDURAL CHARACTERISTICS WERE INVESTIGATED. A TOTAL OF 4,467 OCT/OFDI PULLBACK EXAMINATIONS WERE PERFORMED IN 1,754 PATIENTS. IN CASES WHERE OCT WAS USED, VFIB OCCURRED IN 23 OF 1,651 PATIENTS. (DOI:10.1252/CIRCJ.CJ-19-0736)